Howard N. Winfield, MD, discussed surgeons’ mistakes from the genitourinary (GU) perspective in his presentation “Prevention & Management of Urological Laparoscopic Complications.” The rate of complications increases
Howard N. Winfield, MD, discussed surgeons’ mistakes from the genitourinary (GU) perspective in his presentation “Prevention & Management of Urological Laparoscopic Complications.” The rate of complications increases
The Efficacy of Viewing an Educational Video as a Method for the Acquisition of Basic Laparoscopic Suturing Skills. Akl MN et al. 2008;15(4):410–413 • The twelve participants in this prospective observational study were evaluated performing 5 tasks after watching a 6 minute basic principles video: needle intro through trocar, needle loading and positioning, running continous suture, intra- and extracorporeal knot tying. The authors concluded that an educational video appears to be an effective method.
ASIANAMERICAN MULTISPECIALTY SUMMIT: A DIVERSE PROGRAM COVERING INNOVATIVE TECHNIQUES
WILLIAM E. KELLEY, JR., MD
SLS members attending the AsianAmerican MultiSpecialty Summit III in Honolulu were treated to an excellent and diverse program of scientific as well as cultural presentations. We learned about endoscopic breast surgery in India, multiple approaches to laparoscopic colon surgery (including robotic), complex laparoscopic surgery for endometriosis, the varied surgical presentations of tuberculosis, robot-assisted laparoscopic aortoiliac surgery, and complex advanced laparoscopic surgery through a single 18-mm umbilical incision.
Dr. Paul Curcillo and his colleagues from Drexel University presented their multidisciplinary experience with single-port access (SPA) laparoscopic surgery, also known as single-incision laparoscopy (SIL). Laparoscopic gallbladder, foregut, and gynecologic procedures were described in detail. Other current applications include urologic, colorectal, hernia, and spleen surgery.
The multidisciplinary applications of SPA are expanding, and the potential significance of the technique is yet to be recognized. Safety and efficacy studies of SPA are underway in many institutions. The technique has potential incremental advantages over traditional MIS for cosmesis, wound infection, postoperative pain (especially in upper abdominal surgery), and recuperation. Specialized disposable and reusable instruments are being produced to facilitate SPA, but no major capital investments are required. Many advanced laparoscopic procedures are being performed via SPA using traditional laparoscopic instruments, thus keeping costs competitive with costs for traditional MIS. Traditional laparoscopic 2-handed dissection, ablation, and suturing techniques are utilized, so surgeon training in SPA should be much less painful than the transition from open surgery to traditional laparoscopic surgery in the early 1990s was. Most procedures are currently being carried out using a 5-mm camera trocar and two 5-mm working trocars, all introduced through one peri-umbilical incision. A flexible, radially dilating, 3- or 4-channel port could certainly be envisioned for the near future.
Much attention is being paid to totally incision-free, natural orifice translumenal endoscopic surgery (NOTES). This surgery, presently experimental, has the potential for more significant improvement in cosmesis, skin infections, hernias, postoperative pain, and recuperation. NOTES must be distinguished from fully endolumenal, natural orifice surgery (NOS), such as cystoscopic, colonoscopic, transanal, and endoscopic procedures carried out within a hollow structure. NOTES technology, by contrast, is designed to produce an opening in an unrelated organ which must be safely and reliably repaired at the end of the procedure. In NOTES, a highly specialized, sophisticated instrument is passed through an incision in the stomach, vagina, bladder, or colon to access the peritoneal cavity, thus upgrading the potential severity of complications as a result of the entry process. Animal studies are underway in many institutions evaluating the risks of transluminal entry of this kind and attempting to develop the optimal endoscopic closure technique , as well as the ideal endoscopic vehicle and effector instruments. As of July, 2008, seven clinical papers have been published describing experience with 10 peritoneoscopies , 3 appendectomies , 1 cholecystectomy , and 1 repair of a dislodged PEG tube , four cholecystectomies , and two hybrid studies of one cholecystectomy with two 3 mm umbilical trocars , and three cholecystectomies with a 5mm left upper quadrant trocar . It is widely recognized that substantial technological development and years of experience in dedicated centers will be needed to evaluate and perfect NOTES technology.1 As the instrumentation evolves, safety and efficacy studies will be needed followed by extensive outcome studies comparing NOTES results with results for traditional MIS.
In the meantime, SPA has a much stronger potential to be safely learned by experienced laparoscopic surgeons and may offer some advantages over traditional MIS with comparable cost. Practicing surgeons and community hospitals that are so inclined should be able to acquire the skills and instrumentation and offer patients this alternative to NOTES during the early developmental phase of the translumenal procedures. SPA may serve as a bridge, a transition, an adjunctive safety procedure, or ultimately an alternative to NOTES. Comparative outcome studies among all of these techniques will be critically important.
SLS is indeed fortunate to have hosted the first presentation of single-port access surgery at a national meeting, delivered by Dr. Curcillo at the SLS Cyber Café during the San Francisco meeting in 2007. The first scientific paper presentations were performed by Dr. Curcillo and his colleagues at the AsianAmerican MultiSpecialty Summit in February. They have submitted 4 papers for the SLS Meeting and EndoExpo in Chicago this September discussing SPA hysterectomy and oophorectomy, SPA colon resection, their first 100 SPA cholecystectomies, and 1-year follow-up for their early cohort of SPA cholecystectomies. Dr. Dan Geisler will also be presenting Single-Port Laparoscopic Colectomy in Chicago.
William E. Kelley, Jr., MD, President of the Society of Laparoendoscopic Surgeons, is the Director of General Surgery for the Minimally Invasive Surgery Center of Virginia. He is in private practice with The Richmond Surgical Group in Richmond, Virginia, and serves on the clinical faculty at the Medical College of Virginia. Dr. Kelley serves on the editorial board of JSLS. He has contributed over one hundred-fifty papers and presentations in the fields of surgical oncology, minimally invasive surgery, image guided breast surgery, and robot-assisted surgery, and textbook chapters in laparoscopic antireflux, colon and spleen surgery.
Correspondence: William E. Kelley, Jr., MD, 8921 Three Chopt Rd, Ste 300, Richmond, VA 23229, USA. Telephone: 804 285 9416, Fax: 804 285 0840, Email: Bill.Kelley@Earthlink.com
1. Flora ED, Wilson TG, Martin IJ, O’Rourke NA, Maddern GJ. A review of natural orifice translumenal endoscopic surgery (NOTES) for intra-abdominal surgery, experimental models, techniques, and applicability to the clinical setting. Ann Surg. 2008;247;583-602.
2. Hazey JW, Narula VK, Renton DB, et al. Natural-orifice transgastric endoscopic peritoneoscopy in humans: initial clinical trial. Surg Endosc. 2008;22:16-20.
3. Tsin, DA, Colombero LT, Lambeck J, et al. Minilaparoscopy-assisted natural orifice surgery. JSLS. 2007;11:24-29.
4. Marescaux J, Dallemagne B, Perretta S, Wattiez A, Mutter D, Coumaros D. Surgery without scars. Arch Surg. 2007;142: 823-827.
5. Marks JM, Ponsky JL, Pearl JP, et al. PEG “rescue”: a practical NOTES technique. Surg Endosc. 2007;21:816-819.
6. Zorron R, Maggioni LC, Pombo L, et al. NOTES transvaginal cholecystectomy: preliminary clinical application. Surg Endosc. 2008; 22:542-547.
7. Decarli L, Zorron R, Branco A, et al. Natural orifice transluminal endoscopic surgery (NOTES) transvaginal cholecystectomy in a morbidly obese patient. Obes Surg. 2008;18:886-889.
8. Forgione A, Maggioni D, Sansonna F, et al. Transvaginal endoscopic cholecystectomy in human beings: preliminary results. Laparoendosc Adv Surg. 2008;18:345-351.
FROM THE 16TH SLS ANNUAL MEETING AND ENDO EXPO 2007, SAN FRANCISCO, CALIFORNIA, SEPTEMBER 5–8, 2007
A great new approach to poster presentations was launched at the 16th SLS Annual Meeting and Endo Expo 2007. It is called the Poster Town Hall. From all the posters presented, the “Best Poster” was chosen in general surgery, urology, gynecology, and multispecialty. Recipients of these Best Poster awards re-presented there work in five minute oral slide presentations. The “Best of the Best” poster was chosen, and the authors received a $500 prize. This year’s “Best of the Best” poster award went to “Does Purchasing a da Vinci Robot Make Sense for a Mature Laparoscopic Prostatectomy Program?” by Peter L. Steinberg, MD, Paul A. Mergurian, MD, John A. Heaney, MB, William Bihrle, III, MD, John D. Seigne, MB.
Development of a Method for the Consistent Creation of Experimental Pelvic Adhesions in a Swine Model
Submitted by Bradford W. Fenton, MD, PhD, Michelle Evancho-Chapman, James Fanning, DO
An animal model is lacking that allows for an easily replicable wound that produces consistent pelvic adhesions for use in adhesion prevention research. In this study using a swine model, a low-powered longitudinal electrocautery injury to the pelvic sidewall adjacent to a similar injury of the uterus and held in place with retention sutures for 14 days consistently generated dense, but anatomically delimited, adhesions between the pelvic sidewall and uterine horn. This technique can provide the basis for further quantitative analysis of adhesion prevention techniques.
Best Poster—General Surgery
Does Purchasing a da Vinci Robot Make Sense for a Mature Laparoscopic Prostatectomy Program?
Submitted by Peter L. Steinberg, MD, Paul A. Mergurian, MD, John A. Heaney, MB, William Bihrle, III, MD, John D. Seigne, MB
Robotic-assisted prostatectomy (RAP) and laparoscopic prostatectomy (LRP) are equivalent in terms of outcomes. We performed a cost benefit analysis of obtaining a da Vinci robot to provide recommendations about transitioning from LRP to RAP. We found that if a center does a high volume of prostatectomies, then converting to RAP is feasible and profits can be maintained. However, for low-volume programs (<25 cases/year), the high cost of the robot makes if not fiscally viable. If a robot is donated, costs are less and allow for reasonable revenues without drastic increases in caseloads. Because LRP and RAP outcomes are comparable, hospitals should weigh the market forces against the intangible benefits of robotics to determine whether such benefits outweigh the expenses of owning and operating a robot.
A Case of Large Urachal Cyst Treated by Laparoscopic-assisted Surgery
Submitted by Takashi Yamada, MD, Hiroshi Mori, MD
Laparotomy is the usual treatment of symptomatic urachal cysts, which develop from persistent urachal remnants. Our patient had a clinical diagnosis of an ovarian cyst. However, upon laparoscopic surgery for its removal, no ovarian cyst was found. Through the laparoscope, a cystic mass was seen hanging from the anterior abdominal wall. Using laparoscopic assistance, the cystic fluid and the tissue were removed. A histology study indicated that this was a urachal cyst. Thus, laparoscopic-assistance was used both for removal of this large type of cyst as well as for its diagnosis.
From the 16th SLS Annual Meeting and Endo Expo 2007, San Francisco, California, September 5–8, 2007
Laparoscopy updates are presented at SLS Annual Meetings by members of SLS’ Special Interest Group (SIG) Committees. SIG committee members support the educational mission of SLS through prearation of the updates as well as preparing “Patient Information Pages. ” Learn more at www.SLS.org.
The Winners and Losers: Urologic Update in Minimally Invasive Surgery 2007
Presented by Howard Winfield, MD
Over the past 15 years, almost every type of abdominal or pelvic surgery has been tried laparoscopically or robotically. Which of these procedures have proven to be better than the open procedure (the winners) and which have proven to be worse (the losers)? Laparoscopic radical, simple and donor nephrectomy and laparoscopic adrenalectomy are winners and have become the gold standard. Patients have a better postoperative outcome and the end points of cancer cure or removal of the disease organ are equal to that of open surgery. Robotic-assisted radical prostatectomy for prostate cancer is a winner, being as good as or better than the open procedure in terms of blood loss, continence, hospitalization, and convalescence. In 2007, it is estimated that over 50% of radical prostatectomies will be done robotically. Some losers include laparoscopic partial nephrectomy, radical cystectomy and urinary diversion, ureterolysis for retroperitoneal fibrosis, and retroperitoneal lymph node dissection for testis tumor, which have not been shown to be better than the open procedures. Laparoscopic varix ligation for treatment of varicoceles and bladder neck suspension for female stress urinary incontinence are not as good as microsurgical varix ligation and transvaginal bladder suspension. As for pediatric laparoscopic and robotic procedures, they are still developing and have little strong support among practitioners.
Update Abdominal and Pelvic Pain and Adhesions
Does Adhesion Cause Pain? Should We Perform Adhesiolysis for Treatment of
Presented by Maurice K. Chung, MD
Adhesions, fibrous tissues connecting organs that are normally separated, cause infertility, chronic pelvic pain, small bowel obstruction, and intraoperative complications, all of which generally lead to subsequent surgery. Pelvic adhesions are very common after pelvic surgery. If adhesions to the peritoneum are mobile, pain is more frequent, but when adhesions are fixed, no pain is experienced. Pelvic adhesions exist in 15% to 45% of patients with chronic pelvic pain; however they may or may not be the cause of the pain. Treatment of adhesions is controversial because surgery may cause the formation of more adhesions. Adhesiolysis decreases pain, but many patients experience a recurrence over time. In a study of 105 patients with previous abdominal surgeries, 50% (52) had adhesions on second look, and 52% (27) had pelvic pain. Twenty of the 27, however, had a positive potassium sensitivity test (74%) and 2 had a positive cystoscopy/ hydrodistention (7.4%), indicating painful bladder syndrome. After treatment for IC/PBS, the pain stopped or decreased by at least 50%.
The Role of Laparoscopy and Robotics in Hysterectomy
Presented by Ceana Nezhat, MD
The rate of hysterectomies performed has remained stable for the past 2 decades, but the number of laparoscopic and laparoscopic-assisted vaginal hysterectomies has doubled. Laparoscopy is being used more frequently in complicated hysterectomies in patients with malignancy. Instruments are being improved that will decrease OR time, reduce morbidity and patient recovery time, and will advance minimally invasive hysterectomies. With progress in radio frequency technology, advances are being made in vessel sealing devices. These new devices allow quick sealing of uterine vessels and ligaments with little tissue damage and charring, thus decreasing OR time, blood loss, and recovery time. Robotic surgery has made laparoscopy even more advantageous because of the improved physical comfort for the surgeon, better visualization with 3-D images and magnification, and instrumentation that corrects for hand tremor and allows better access. Some drawbacks to robotic surgery, however, are expensive equipment, lack of tactile feedback for the surgeon, and increased preparation time and staff training.
FROM THE 16th SLS ANNUAL MEETING AND ENDO EXPO 2007, SAN FRANCISCO, CALIFORNIA, SEPTEMBER 5–8, 2007
Best Scientific Paper—Gynecology
Staging of Advanced Ovarian Cancers: Interest in Thoracoscopy
Submitted by Anne-Sophie Bats, MD, Sandra Cohen-Mouly, MD, Reda Souilamas, MD, Cherazade Bensaid, MD, Marie Junger, MD, Florence Larousserie, MD, Fabrice Leceru, MD, PhD
Thoracoscopy can improve the staging of ovarian cancer and allow the changing of therapeutic management of patients with advanced ovarian cancer associated with pleural effusion. Eight thoracoscopies were performed on the right side and 3 on the left side. One of them was stopped for refractory hypoxemia. Pleural effusion recurred in only one case. Of these 11 patients, 4 women had pleural metastases diagnosed by thoracoscopy, whereas the thoracic CT scan was normal; 3 patients were classified in the 4th stage of cancer because of pleural effusion, but thoracoscopy confirmed the diagnosis due to negative biopsies. In 2 patients, the pleural disease was more severe than was the abdominal extension. These women were recommended for chemotherapy.
Best Scientific Paper—Urology
Comparative Review of Laparoscopic and Robotic-assisted Radical Cystectomy with Ileal Conduit Urinary Diversion
Submitted Matthew N. Simmons MD, PhD, Inderbir S. Gill, MD, MCh
No uniform reporting methods are available to compare outcomes data for laparoscopic partial nephrectomy (LPN); therefore, outcomes data are limited. We used a standardized complications reporting system to analyze complications in a contemporary cohort of 200 patients from an LPN database of over 500 patients. Thirty-five (17.5%) patients had complications. The overall complication rate was 19%. Of the complications, 20% were grade I, 42% were grade II, 26% were grade III, and 2.6% were IV. No grade V complications occurred. Compared with the first 200 patients in our LPN cohort, this contemporary cohort had significant decreases in overall, urologic, and hemorrhagic complication rates despite an increase in tumor complexity. Increased experience with advanced laparoscopic techniques has allowed for a significantly reduced complication rate after contemporary laparoscopic partial nephrectomy (LPN), which now appears comparable to that of open partial nephrectomy. We advocate the development of a standardized complication reporting system.
Best Scientific Paper—Multispecialty
Experimental Studies of Peroral Transgastric Abdominal Surgery: Tubectomy, Hysterectomy. Is it the Next Minimal Invasive Approach?
Submitted by Stefanos Chandakas, MD, MBA, PhD, Chris Feretis, MD
Peroral transgastric surgery, a less invasive type of surgery, is technically feasible and safe in a porcine model and needs to be studied further. We performed incisionless endoscopic peroral transgastric procedures on 10 anesthetized pigs, which included peritoneoscopy, liver biopsy (1), cholecystectomy (6), fallopian tube excision (1), and hysterectomy (1). In 4 animals, peritoneoscopy liver biopsy and cholecystectomy were performed successfully without intraoperative complications. In survival studies, 6 of the 10 pigs that underwent cholecystectomy, tubectomy, and hysterectomy had uncomplicated recover at 4 to 6 weeks.
Best Scientific Paper—General Surgery
Laparoscopic-assisted Colonoscopic Polypectomy: Long-term Results
Submitted by Morris E. Franklin, Jr, MD, Guillermo Portillo, MD, Jefrey L. Glass, MD, John J. Gonzalez, Jr, MD
A combined endoscopic-laparoscopic approach offers a valid alternative for treating difficult colonic polyps and eliminates the morbidity of a segmental resection. Long-term follow-up demonstrates that this technique is safe and effective. A total of 190 polyps were removed as follows: 112 right colon (59%), 23 transverse (12%), 12 left colon (7%), and 33 rectosigmoid (22%). In 96% of patients, laparoscopic-monitored colonic polypectomies were performed successfully. Full-thickness resection was required in 4% of patients because of technique problems and positive margins. In a mean follow-up of 74 months, there have been no recurrences.
PRIMUM NON NOCERE
MICHAEL STARK, MD, HENNING BABERG, MD
Mortality and complications are undesirable but occur occasionally following any surgical procedure. Traditionally, many complications are considered unavoidable and result from uncontrollable factors related to the nature of the disease and general health condition of the patient (for example, the existence of diabetes or obesity) . Efforts have been made to reduce morbidity and mortality through preoperative risk assessment, identifying risk factors, and preparing patients accordingly . Preoperative assessment of patients with heart diseases, for example, has proved to be beneficial . Despite careful evaluation, complications still occur. In a prospective study of colon cancer operations, the mortality rate for elective cases was 3.5% and the complication rate 24% compared with 10% mortality and a 38% complication rate in emergency procedures . In the developing world, postoperative complications may be even higher. An audit of anesthesia-associated mortality in Zimbabwean teaching hospitals demonstrated that poor preoperative and postoperative management was a factor contributing to 51% of the avoidable deaths .
Although Hieronymus has already declared that “errare humanum est,” preventable complications are inexcusable. Despite the best of clinical intentions, preventable complications resulting from human factors are frequent and pervasive. Examples include improper procedures for identifying patients, inadequate preoperative evaluation, ignorance of important clinical history (like allergies), and the failure to confirm that adequate equipment and blood products are available when needed. Essential imaging, appropriate and timely administration of antibiotics, and venous thromboembolism prophylaxis, preparation for blood loss, confirmation of equipment sterility, surgical counts, and appropriate labelling of specimens are of utmost importance but are frequently neglected. In addition, clear plans for postoperative management are infrequently communicated but should be defined at the end of the operation, taking into account the condition of the patient and the procedure he or she underwent.
Despite over 100 years of modern surgical experience and many avoidable complications being reported in the media and professional literature, errors still do occur. Although the experience of the surgeon plays a vital role, communication between surgeons, anesthesiologists, and nurses is critical for success in avoiding preventable human error [6,7]. Checklists have proved useful to ensure safety in many industries that require complex human interaction. In aviation, checklists for flight safety are routine. The aviation safety authorities demand that pilots should use predesigned checklists before take off or landing, leaving nothing to the pilot’s memory. The items checked anticipate most seen or unforeseen occurrences. This approach is beginning to infiltrate the medical world, and checklists are already being used in anesthetia practice . Although safety measures have been taken for quality surgical improvement, such as the American College of Surgeon’s National Surgical Quality Improvement Program (NSQIP) , a general strategy has not been introduced.
The WHO Guidelines for Safe Surgery (Safe Surgery Saves Lives)
In 2002, the 55th World Health Assembly adopted a resolution calling to secure the safety of health care and monitoring systems. In May 2004, the 57th World Health Assembly approved the creation of an international alliance for improving patient safety, and the World Alliance for Patient Safety was launched in October 2004. As part of this initiative, the “Safe Surgery Saves Lives” program was formed. For the first time, policy makers, surgical associations, anesthesia societies, and nurses from the entire world met to discuss and find pathways to reduce the adverse consequences of unsafe health care .
One of the results of this work was the creation of a surgical safety checklist, introduced to a wide clinical audience after a year of intensive consultative work with surgeons, anesthesiologists, nurses, and patient safety experts. The project was lead by Atul Gawande from the Department of Health Policy and Management at the Harvard School of Public Health, who is a surgeon at Brigham and Women’s Hospital in Boston. The WHO Surgical Safety Checklist identifies crucial safety steps divided into 3 phases, each corresponding to a specific period during normal operative workflow: before the induction of anesthesia (“sign in”), before skin incision (“time out”), and before the patient leaves the operating room (“sign out”). In each phase, the checklist helps confirm that the surgical team has completed its critical safety tasks before proceeding. This checklist is clear and concise, user friendly, and promotes an ongoing dialogue among surgeons, anesthesiologists, and surgical nurses (Figure 1).
The WHO Surgical Safety Checklist identifying crucial safety steps corresponding to the following three stages:
• before the induction of anesthesia (“sign in”);
• before skin incision (“time out”);
• and before the patient leaves the operating room (“sign out”).
During the sign in, patient identity and consent for surgery are confirmed; the operative site is marked; and the risk of blood loss, airway difficulty, and allergic reaction is reviewed. For the time out, team members introduce themselves, confirm out loud that they are performing the correct operation on the correct patient and site, and then verbally review any critical elements of the operation. Antibiotic administration and imaging availability are also confirmed as appropriate. The sign out guides a review of the operation performed, completion of sponge and instrument counts, labeling of any surgical specimens, equipment malfunctions or issue, and the key plans and concerns for postoperative management and recovery.
This checklist was designed to be suitable for any operation in any surgical discipline and can be used in developed countries as well as in countries with limited resources. It is accompanied by a WHO Guideline book that outlines the 10 essential objectives of safe surgery, explaining the importance of each one and reviewing the relevant literature .
Introduction of the Checklist
The New European Surgical Academy (NESA) was a consultant in this project and decided to initiate use of the checklist. The checklist was introduced and accepted for use by the HELIOS Hospitals Group, one of the biggest of its kind in Europe. The departments of obstetrics and gynecology were the first to adopt the checklist into daily clinical practice.
The checklist was introduced to all the heads of Ob/Gyn departments on March 20, 2008, and the concept was unanimously accepted. Between April 15, 2008 and July 15, 2008, clinicians used the checklist during the performance of 1340 major operations. Using the checklist has not caused undue delays, and with practice it has been easily incorporated into the normal operating room routine. The staff were enthusiastic, and its use seems to have improved communication between all clinical disciplines involved in surgical care.
All patients undergoing surgery expect the best possible care and trust clinicians to minimize the risks of injury and death. There are always unavoidable risks related to the underlying condition and comprise an important part of the informed consent [11,12]. Risks resulting from lack of communication between staff members or from failure to follow basic standards of safe care can cause severe harm and violate the dictate of “primum non nocere.” Our goal as surgeons is to reduce this risk. In addition to the clear benefits to the patient and clinicians, the financial savings associated with reduced complication rates cannot be ignored [13,14].
The experience with the checklist demonstrates that introducing a checklist designed to improve safe practices has been uneventful, has promoted interdisciplinary dialogue, and has been enthusiastically accepted. Following this initial pilot study, the checklist will be introduced to all the surgical departments of the HELIOS Hospitals Group and is expected to contribute to the safety and well being of patients. We recommend any surgical department to start using this simple, efficient checklist as a tool to reduce the likelihood that proven standards of care have been omitted or overlooked and to improve the safety of surgery everywhere.
Michael Stark, MD, the president of the New European Surgical Academy, created the first European based working group on Natural Orifice Surgery. He is the chairman of the ob/gyn departments of the HELIOS group and developed modified surgical procedures like the Misgav-Ladach CS and the Ten-Step Vaginal Hysterectomy.
Henning Baberg MD, is a graduate of the Bochum Medical School (Germany) and also studied at San Diego University. He is a cardiologist and associate professor for internal medicine. Since 2005 he is the head of organization and process development of the HELIOS group which manages 60 hospitals with 30,000 employees.
The authors thank Dr. Thomas Weiser from the Department of Health Policy and Management of the Harvard School of Public Health for his assistance.
Correspondence: Michael Stark, MD, President, The New European Surgical Academy (NESA), Karower Str. 11 /214, 13125 Berlin, Germany. Telephone: +49 30 9401 2403, Fax: +49 30 9401 2430, Email: firstname.lastname@example.org
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2. Pan W, Hindler K, Lee VV, et al. Obesity in diabetic patients undergoing coronary artery bypass graft surgery is associated with increased postoperative morbidity. Anesthesiology. 2006;104(3):441-447.
3. Poldermans D, Hoeks SE, Feringa HH. Pre-operative risk assessment and risk reduction before surgery. J Am Coll Cardiol. 2008;51(20):1913-1924.
4. Mangano DT. Preoperative assessment of the patient with cardiac disease. Curr Opin Cardiol. 1995;10(5):530-542.
5. McKenzie AG. Mortality associated with anaesthesia at Zimbabwean teaching hospitals. S Afr Med J. 1996;86(4):338-342.
6. Zorcolo L, Covotta L, Carlomagno N, et al. Toward lowering morbidity, mortality, and stoma formation in emergency colorectal surgery: the role of specialization. Dis Colon Rectum. 2003;46(11):1461-1467; discussion 1467-1468.
7. Sexton JB, Makary MA, Tersigni AR, et al. Teamwork in the operating room: frontline perspectives among hospitals and operating room personnel. Anesthesiology. 2006;105(5):877-884.
8. Hart EM, Owen H. Errors and omissions in anesthesia: a pilot study using a pilot's checklist. Anesth Analg. 2005;101:246-250.
9. Rowell KS, Turrentine FE, Hutter MM, et al. Use of national surgical quality improvement program data as a catalyst for quality improvement. J Am Coll Surg. 2007;204(6):1293-1300.
10. WHO. World Alliance for Patient Safety. WHO guidelines for safe surgery. WHO/IER/PSP/2008.08-1E; 2008.
11. Dittmann V. Judgement and informed consent. Ther Umsch. 2008;65(7):367-370.
12. Giesen D. The patient's right to know--a comparative law perspective. Med Law. 1993;12(6-8):553-565.
13. Dimick JB, Weeks WB, Karia RJ, et al. Who pays for poor surgical quality? Building a business case for quality improvement. J Am Coll Surg. 2006;202(6):933-937.
14. Dimick JB, Chen SL, Taheri PA, et al. Hospital costs associated with surgical complications: a report from the private-sector National Surgical Quality Improvement Program. J Am Coll Surg. 2004;199(4):531-537.
PICK FROM JSLS, JOURNAL OF THE SOCIETY OF LAPAROENDOSCOPIC SURGEONS
PRATHIMA KANUMURI, MD, SABHA GANAI, MD, EYAD M. WOHAIBI, MD, RONALD W. BUSH, BS, DANIEL R. GROW, MD, NEAL E. SEYMOUR, MD
The advent of simulation training of minimally invasive surgical skills has created significant opportunities for ongoing development of innovative training methods. Several recent investigations have shown that the use of computer-driven simulation training devices results in transfer of skills into the operating room environment [1-4], and mandatory application of simulation methods has been forwarded as a means of improving surgical results and patient safety . A growing number of laparoscopic simulation training platforms and generally limited institutional resources have created difficulties for educators faced with the prospect of introducing these training methods into their programs . Ideally, the decision to procure a specific device ought to be based on the anticipated effectiveness in the specific application for which it will be used.
A wide variety of laparoscopic simulators is now available, and they can be broadly classified into videoscopic and computer-driven laparoscopic simulation platforms, which are further divided into virtual reality (VR) and computer-enhanced videoscopic (CE) trainers. These trainers primarily differ in their user interface and ability to provide reliable performance measurements. Videoscopic trainers allow manipulation of actual physical objects and require manual data collection. In contrast, VR trainers utilize a virtual environment and provide computer automated performance metrics. CE trainers attempt to bridge the gap between videoscopic and VR systems, their user interface is similar to the former, but they provide computer-generated performance metrics like VR trainers do . Despite these fundamental differences, their intended purpose is the same: To provide assessment and training in specific skills based on sophisticated performance measurement capabilities that would not be available without the use of desktop computing. Effective performance measurement is the basis for establishment of performance objectives and for proficiency-based training, which is emerging as the educational model of choice in skills training .
In the present study, we examined training effectiveness of examples of the 2 classifications of computer-driven laparoscopic skills trainers using proficiency-based training models with the specific aims of (1) demonstrating that novice surgical trainees can acquire complex laparoscopic skills using fundamentally different simulation systems and (2) to demonstrate that the use of performance objectives established by a homogeneous group of more advanced trainees will result in similar levels of
skills improvement with the 2 systems.
Study participants were 16 Tufts University School of Medicine third-year medical students on their General Surgery and Obstetrics and Gynecology clerkships at Baystate Medical Center. The study was exempted from full review by our Institutional Review Board, and informed consent was not required for enrollment. The general study design called for students to undergo a pretraining assessment in laparoscopic intracorporeal suturing and knot tying. Participants were then randomized to train to perform this task using either a VR (n=8) or CE (n=8) simulator. At the end of the 4-week clerkship, a posttraining assessment identical to the pretraining assessment was conducted, and students had to complete an end of study survey characterizing qualitative aspects of their training experience.
Pre- and Posttraining Assessments
The pre- and posttraining assessments consisted of performance of a laparoscopic suturing and intracorporeal knot tying task in a live anesthetized porcine model (25kg to 30kg, Yorkshire pig sedated with intramuscular ketamine 100mg/kg and xylazine 10mg/kg and maintained under general anesthesia using endotracheal isoflurane) under a specific protocol approved by the Institutional Animal Care and Use Committee. Immediately before both assessments, all participants received standardized didactic instruction explaining task performance as described in the SAGES Fundamentals of Laparoscopic Surgery (FLS) course, and viewed the FLS video demonstration of a suturing and knot tying sequence. This was followed by a brief quiz to assess their understanding of the task and associated errors. In the operating room, each student was given 5 minutes (min) to perform the task, which was video-recorded for subsequent analysis. The specific task consisted of approximation of 2 loops of small intestine using standard instrumentation and laparoscopic port placement. This was accomplished with 2-0 silk suture and SH needle (Ethicon) with an initial surgeon’s knot and then 2 subsequent square throws. The animal was euthanized after the assessments were completed. Although general instructions were provided, no mentoring or feedback was given during student performance of any task.
VR simulation training was conducted using MIST-Suture software (SimSurgery, AS, Oslo, Norway). “Interrupted Suture” task was run on a MIST-VR simulator (Mentice AB, Göteborg, Sweden) with an Immersion Virtual Laparoscopic Interface (Immersion Medical, Gaithersburg, MD) (Figure 1). Performance metrics consisted of a composite score for time and errors.
CE training was accomplished using a ProMIS simulator (Haptica Ltd., Dublin, Ireland) (Figure 2), and a custom model of 2 adjacent 1-inch Penrose drains that permitted the intracorporeal suturing and knot tying task to be performed with the same technique and instrumentation used for the operating room assessments. This simulator consists of a torso model containing optical motion sensors to detect instrument movement characteristics. Performance metrics consisted of time, instrument path length, and smoothness of motion.
To facilitate distributed learning of the task, students were scheduled for 8 one-hour mentored training sessions over the 4-week rotation, but were permitted to have additional training under the same conditions. VR and CE training was mentored by either the full-time skills lab training technician or a surgeon researcher, both of whom were experts in performing the task. The training objectives for each system were based on the performance scores of 2 fourth- and 2 fifth-year general surgery residents. For the purposes of this study, proficiency was defined as achievement of performance scores within one standard deviation (SD) of the predefined objectives on 3 consecutive task iterations.
After the posttraining assessment, students completed a survey soliciting demographic information and prior laparoscopic experience (description of specific activities during cases). Qualitative impressions of the importance of simulation training, the importance of haptic cues in simulators, and the educational value of the specific training system used, were surveyed with responses given on a 3-point scale of “very effective,” “effective,” or “not effective.”
The pre- and posttraining assessment videos were reviewed by 2 independent surgeon raters, blinded to student identity and training status, using a performance assessment tool previously validated at our institution . For the purposes of this analysis, the task was divided into 2 phases. In the “Suturing Phase,” the needle was brought to a functional position, driven through the 2 loops of bowel, and then secured after the suture was pulled through the tissue to the appropriate length to permit knot tying. The “Knot-tying Phase” was defined as the performance of a surgeon’s knot and then 2 successive square simple throws to complete a square knot. Video rating consisted of quantifying discreet events during each phase that pertained to efficiency, expert-defined correct behaviors, and specific errors to produce a summative performance score.
Data are expressed as means with 95% confidence intervals (CI). Comparisons between groups were conducted by Mann Whitney U test and comparisons within groups before and after training by Wilcoxon matched pairs test. Comparisons of achievement of proficiency, task completion rates, and questionnaire data were by Fisher’s exact test. The Mann Whitney U test was performed using Epi Info software (Version 3.3.2, Centers for Disease Control, Atlanta, GA), and Wilcoxon matched pairs test and Fisher exact test were performed using GraphPad Instat software (San Diego, CA). Statistical significance was taken at a P<0.05.
The average age of the participants was 26±1 years, and the sex distribution was 63% (n=10) male and 37% (n=6) female. The participants had minimal prior laparoscopic experience, ranging from no experience to holding the camera.
Performance curves for the VR and the CE-trained groups had a classic appearance of early, rapid improvement, followed by a more gradual pattern of incremental improvement (Figure 3). There were no significant differences in the proportion of students who reached proficiency [VR 75% (n=6); CE 88% (n=7)] and in percentage compliance for scheduled training sessions (VR 73%; CE 67%) (Table 1). The sum of total recorded task time was comparable between groups [VR 115 min (range, 61 to 169); CE 111 min (85-136); P>0.05]. However, the total number of iterations completed by the VR-trained students was significantly lower compared with that of CE-trained students [VR 17 (8-26); CE 38 (30-45); P<0.05], because the time taken to complete one iteration on the VR trainer was longer than that on the CE trainer (VR 9±2 min; CE 3±1 min). Time taken to reach the predefined proficiency level was significantly shorter in the VR group compared with that in the CE group [VR 43 min (range, 28 to 59); CE 75 min (range, 45 to 104); P<0.05).
Pre- versus Posttraining Assessment Performance
The interrater reliability for video analysis of pre- and posttraining performance was 0.88. The overall task completion rate was significantly higher posttraining for both the VR-trained and CE-trained groups (P<0.01) (Table 2). The time to task completion decreased on the posttraining assessment (P<0.01) for both the VR (P<0.05) and CE (P<0.01) groups. It must be noted that time to task completion did not represent a true value, reflecting completion of the task in all students because the longest possible figure for task time capped at the 300 second limit. This resulted in a larger effect on the pretraining assessment, where 13 of 16 students did not complete the task. Despite this limitation, the decrease in mean time after training was highly significant. Suturing phase time and video analysis score were also compared because all students completed this phase on both pre- and posttraining assessments. A significant improvement was demonstrated for both measures in the VR-trained group but not in the CE-trained group. Comparison of pre- and posttraining total video analysis scores was not feasible due to the very low task completion rate on pretraining assessment (3 of 16 participants). No significant differences were noted between groups on the pretraining assessment with the exception of the suturing phase score, which was higher in the CE group. The 2 groups did not differ in their posttraining assessment time or total video analysis score.
Survey responses indicated that students had minimal exposure to laparoscopic surgery, ranging from no experience to watching cases and holding the camera. Students generally felt that haptic feedback was important during training on simulators, and that the use of the 2 platforms was effective in increasing their skill levels, without any significant differences in the frequency of “effective” and “very effective” responses between the 2 groups (Table 3). However, all students in the CE group felt that their system simulated reality effectively, compared with only 38% in the VR group, a difference that was statistically significant.
Based on results from previous studies [1-4], we assumed that laparoscopic skills in novices would improve with objectives-based training and did not include an untrained control arm in the study design. This reflects our belief that properly implemented training on simulator systems with demonstrated face and construct validity will result in skills transfer to an OR setting and that examination of performance relative to totally untrained individuals does not have to be pursued in every circumstance. The repeated measures model utilizing each subject as his or her own control was selected instead, permitting us to address the study aim with an appropriate number of subjects. Medical students with minimal prior laparoscopic experience achieved a training benefit within the framework of a 4-week clerkship. Survey results indicate that over the course of their rotations, activities during laparoscopic teaching cases contributed minimally to the observed improvement in skills.
Although there were no significant differences in either the magnitude of skills improvement achieved with training on the VR system versus the CE system, or in the absolute levels of measured skills at the end of training, the study may not have been sufficiently statistically powered to detect small differences in the magnitude of skills transfer. Despite this, the skills transfer effects of simulation training to operative performance, can be described as comparable. Although pretraining skills were otherwise homogeneous in the 2 groups, a slightly higher CE-trained group pretraining suture phase scoring was observed. This is likely due to a sampling phenomenon with a fairly small experimental group size. The proficiency targets proved to be achievable for the majority of students, and the fact that 3 students did not achieve these objectives did not hinder demonstration of skills transfer. Because training was conducted on platforms that used different performance metrics (time and error composite scores on the VR trainer, and time, path length, and smoothness on the CE trainer), it is difficult to compare some of the training results. Students in the VR training group took less time to reach the designated proficiency targets compared with the CE training group. However, we cannot conclude that the VR system facilitates faster learning because we did not stop training on either system when the proficiency targets were reached, and some students did additional task iterations after achieving proficiency levels. In addition, as stated above, 3 of the students did not achieve proficiency levels. Performance objectives were based on historical performance of PGY 4 and 5 residents, with objectives for VR established 1 year before CE objectives. It is possible that uneven skill levels between disparate groups of residents may have confounded the simulator performance data on which the objectives were based, and also contributed to the differing times to achieve proficiency targets.
The inability to make comparisons of total video analysis scores pre- and posttraining due to the low task completion rate on the pretraining assessment was a limitation in our study. Although we have given the results of the suturing phase score, this value is limited as it represents only a portion of the task that is arguably less difficult than knot tying. The low task completion rate was probably because the task is a fairly difficult one for novices and task performance time was limited to 5 minutes. Time was capped based on the expectation that all students would be able to complete the task in the posttraining assessment after sufficient training. We felt that it was important not to allow the initial assessment to constitute a training opportunity by allowing essentially unlimited time to complete the task. Though a truncated task completion time may seem problematic, we successfully demonstrated a significant improvement in task completion rate and task completion time during the posttraining assessment.
Several prior studies have compared the effectiveness of videoscopic and VR trainers. These have made recommendations that both systems are effective in improving skills , that there may be training value to concurrent use of both system types , or that VR training has an advantage [12,13]. The application of performance objectives in our study allowed us, to a great extent, to ensure that desired performance benchmarks on the 2 system types were comparable. Under these circumstances, although a minority of participants (comparable proportions on the 2 systems) did not achieve these objectives, we have demonstrated that comparable levels of performance improvement can be achieved with trainers that are fundamentally different in the experience provided to users.
Although performance results were similar, we have found in our experience that VR trainers offer some practical advantages over videoscopic and CE trainers. These pertain to automated performance metrics that can be easily retrieved and examined, but more importantly, are obtained under very standardized conditions. During self-directed practice, even with the performance measures available with a sophisticated system such as ProMIS (CE trainer), it is impossible to comment on what actually occurred during training unless video recordings are examined. Because VR tasks are, for the most part, rules-based, performance measures reflect achievement of steps specifically defined in the simulator software. Although this facilitates standardization, software-dependent tasks can be less free-form compared with videoscopic and CE trainers, and such constraints can be viewed as a disadvantage.
Both VR and CE training devices are roughly equivalent in price ($35,000 to $50,000), and the number of facilitator hours for training on the respective systems was also approximately the same (despite the small difference in “time to reach proficiency” between the systems). Hence, there does not appear to be an advantage that would steer a program director to one or the other of these systems. However, it is important to note that VR trainers may prove to be more cost-effective when compared with videoscopic trainers (computer-enhanced, or not) due to considerations that enter the usage picture that might influence the quality of the training experience during self-directed practice. These include automation in the course of uniform task setup, consistent qualitative performance metrics, and mentoring cues in more advanced systems. These features allow more effective self-directed practice in VR, and might necessitate the use of a facilitator with all associated costs to achieve a similar effect on a videoscopic (or CE) trainer. Our study was not designed to analyze the cost-benefit ratio of individual systems, but we believe it is an important question that ought to be addressed in our future work.
The absence of haptic feedback features on the VR system we used permitted some information to be gleaned on the value of these characteristics in this type of training. The presence of “haptic cues,” defined as “sense of touch” or tactile characteristics associated with interactions between physical objects, may have contributed to the higher perceived level of realism associated with the CE trainer. The end-of-study survey results for the 2 systems were comparable, except that CE trainees were more likely to feel that their system simulated reality effectively compared with VR trainees. Because subjects performed pre- and posttests with real laparoscopic instruments in live porcine models, they were able to compare their simulation training experience with “reality,” despite the fact that laparoscopic surgical exposure was limited. Our results are supported by other studies comparing videoscopic trainers and nonhaptic VR trainers [12,14,15]. We hypothesize that this is due to both realism and familiarity issues that do not necessarily result in a degraded training experience. Although the ability to appreciate tactile features of objects with which a surgeon interacts may be perceived as an essential component of learning, there is no compelling evidence to show that it is necessary for the types of skills acquisition we have studied. Despite a clear perception among the participants, irrespective of the training platform used, that haptic features are important in a simulator, the performance results of our study do not substantiate this belief. Because VR trainers at an approximate price point less than $80,000 do not feature haptic user interfaces, this finding is an important one, irrespective of any preconceived beliefs. Considerable development efforts are required to achieve believable force feedback interactions, and newer generation high-fidelity VR simulators that offer this feature are quite expensive . It may be that this higher level of fidelity will be shown to be important for full procedural simulations, but for basic manipulative skills training, the haptic component of fidelity appears to be dispensable. The newest full haptic VR trainers may offer force feedback interactions of sufficiently high quality to permit a comparison of training effectiveness with nonhaptic VR systems to be made using identical software platforms. This would remove the variable of fundamentally different operating environments from the comparison.
Based on this study’s data, we conclude that novice surgical trainees can acquire complex laparoscopic skills using fundamentally different simulation systems provided that training is objectives based and ample opportunities are given to achieve these objectives. However, it is not possible to recommend one simulator type over another. Given the devices that are currently available, it is our belief that expected performance outcomes are more tightly linked to the quality of training and to the clinical assessment methodology, than to the specific features of the simulator. Although the assumption that haptic feedback is important for simulator fidelity may be supportable, it appears that use of a VR system with a nonhaptic user interface permits very similar training results to that achieved with a CE system that allows interaction with real physical objects. Based on our use of these 2 systems, we feel that either can be used in a formative training program with the expectation of a good training effect. The results of future use in routine training activities should provide additional opportunities to confirm the achievement of training goals with virtual reality and hybrid, computer-enhanced training platforms.
Figure 1. MIST-VR simulator (Mentice AB, Göteborg, Sweden) with Immersion Virtual Laparoscopic Interface (Immersion Medical, Gaithersburg, MD) (A). This device was set up to run MIST-Suture software (SimSurgery, AS, Oslo, Norway) on the “Interrupted Suture” task (B).
Figure 2. The ProMIS computer-enhanced simulator (Haptica Ltd., Dublin, Ireland) (A). This device was set up for users to approximate 2 segments of Penrose drain with an interrupted suture (B).
Figure 3. Performance curves for trainees on both virtual reality and computer-enhanced devices had a classic appearance of early, rapid improvement, followed by a more gradual pattern of incremental improvement. Virtual reality device: MIST-VR (A); Computer-enhanced device: ProMIS (B, C, D).
Reprinted from JSLS, Journal of the Society of Laparoendoscopic Surgeons. 2008;12(3):219–226.
Baystate Medical Center, Department of Surgery, Tufts University School of Medicine, Springfield, Massachusetts, USA (Drs Kanumuri, Ganai, Wohaibi, Seymour, Mr Bush).
Baystate Medical Center, Department of Obstetrics and Gynecology, Tufts University School of Medicine, Springfield, Massachusetts, USA (Dr Grow).
Correspondence: Neal E. Seymour, MD, Associate Professor of Surgery, Tufts University School of Medicine, Vice Chairman, Department of Surgery, Baystate Medical Center, 759 Chestnut Street, Springfield, MA 01199, USA. Telephone: 413 794 4025, Fax: 413 794 1764, E-mail: email@example.com
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FROM THE 16TH SLS ANNUAL MEETING AND ENDO EXPO 2007, SAN FRANCISCO, CALIFORNIA, SEPTEMBER 5–8, 2007
PRESENTED BY JOSEPH BRUNER, MD
The types of fetal surgeries being performed are growing. The first in utero surgery was bladder open fetal surgery for lower urinary tract obstruction (LUTO). Liver surgery has been performed, as has congenital high airway obstruction (CHAOS) surgery. PLUG, plug the lung until it grows, is a new method for treating congenital diaphragmatic hernias. A flexible endoscope is inserted in the mouth of the fetus, and a balloon is passed through the throat then expanded to open the lungs. The balloon is popped and the baby expels it. Congenital cystic adenomatoid malformation (of the lung) (CCAM) surgery is also being performed; however, sometimes the fetuses die before they heal. Sacrococcygeal teratoma, congenital germ cell tumor arising from the presacral area, surgery is being performed too, but it has a mortality rate of 30% to 50% because it is difficult to occlude vessels to prevent huge blood loss when the tumor is resected and it is hard to tell where the tumor ends and the fetus begins. Intrauterine therapy has also been performed for nonlethal disorders, such as spina bifida. The da Vinci robot has been used in the sheep model for intrauterine surgery, with all robotic surgeries being performed satisfactorily. Although fetal surgery is promising, it is not without problems. For example, all pregnancies need to be performed by cesarian delivery because of the port holes, the working space is small, it is difficult to work in a gas or liquid environment, fetal positioning, port size, and membrane damage.
FROM THE 16TH SLS ANNUAL MEETING AND ENDO EXPO 2007, SAN FRANCISCO, CALIFORNIA, SEPTEMBER 5–8, 2007
PRESENTED BY JOHN KENAGY, MD, MBA
John Kenagy, MD, a vascular surgeon broke his neck. “Despite the system, said Kenagy, “I had good outcomes.” The system got in the way; but, the good outcome was because of people going the extra mile. He is walking, talking, and has no impaired movements. However, he cannot practice surgery, so he went into management. He helps managers find solutions. It is important to understand that future success is based on one’s ability to adapt to a changing environment, said Kenagy. Current organizations will stall or block adaptive change. According to Clayton Christensen, it is almost impossible for established companies to be innovative. When an industry transforms, it starts at the low end, not the high end. But it is difficult for management leaders to make the leap from the high end to the low end. Toyota is so successful because it is “designed to adapt.” How can a company become adaptive? What is adaptive design? It is adaptive innovation and Toyota combined. First, establish an operational framework that fosters high performance and innovation focused on the patient. Second, eliminate ambiguity, assumptions, work-arounds, and tradeoffs. Third, develop every person’s skills, knowledge, creativity, and problem-solving ability. Fourth, embrace the team. And fifth, make inquiries if things aren’t working smoothly. Key points to remember are the following: senior management must decide where it wants to be; realize that advice of experts is usually useless; discover the adaptive spectrum of opportunity; inventory what you’re doing and rebalance your opportunities; execute your intentions; and the role of management needs to be revitalized. Adaptive units always outperform others. “It is not the strongest who survive,” said Kenagy, “but the most adaptable.”