Lee L. Swanstrom

Development and validation of a comprehensive program of education and assessment of the basic fundamentals of laparoscopic surgery

IN THE LATE 1990S THE Society of American Gastrointestinal Endoscopic Surgery (SAGES) formed a committee (Fundamentals of Laparoscopic Surgery or FLS) and charged it to develop educational materials covering the basic fundamentals of laparoscopic surgery. Four major principles guided the committee’s developmental process. First, comprehensive coverage of the domain of basic laparoscopy was seen as involving two components: one cognitive (declarative knowledge); and the other psychomotor (procedural skill). Second, the focus of the program was to be on the educational material considered unique to laparoscopy and not on material normally encountered during open surgical training. Third, in accordance with the idea of basic fundamentals, any content specific to a particular anatomic location or to a specific laparoscopic procedure was to be avoided. And fourth, the program was to contain mechanisms for assessment as well as for didactic instruction. The overall goal of the FLS program was to ‘‘teach a standard set of cognitive and psychomotor skills to practitioners of laparoscopic surgery’’ in the belief that knowledge and application of these fundamentals would help ‘‘ensure a minimal standard of care for all patients undergoing laparoscopic surgery.’’ The didactic learning modules are

A prospective, randomized comparison of laparoscopic appendectomy with open appendectomy

Background While the advantages of laparoscopic cholecyslectomy are clear, the benefits of laparoscopic appendectomy (LA) are more subtle. We conducted a randomized clinical trial to evaluate whether LA is deserving of more widespread clinical application than it has yet received. Materials and methods Two hundred fiftythree patients with a preoperative diagnosis of acute appendicitis were randomized into three groups. LA with an endoscopic linear stapler (LAS) (U.S. Surgical Corp., Norwalk, Connecticut) was performed on 78 patients, LA with catgut ligatures (LAL) on 89, and open appendectomy (OA) on 86. LA was performed with a three-trocar technique. OA was accomplished through a right lower-quadrant transverse incision. Data with normal distributions were analyzed by analysis of variance. Nonparametric data were analyzed with either the Kruskal-Wallis H test or Fishers exact test. Results The mean operative times for the procedures were 66 ± 24 minutes (LAS), 68 ± 25 minutes (LAL), and 58 ± 27 minutes (OA). The relative brevity of OA compared to LAS and LAL was statistically significant ( P P P = NS). Wound infections were more common following OA (n = 11) than LAL (n = 4) or LAS (n = 0) ( P P P P Conclusions Laparoscopic appendectomy appears to have distinct advantages over open appendectomy. The laparoscopic procedures produced less pain and allowed more rapid return to full activities, and LAS required shorter hospital stays. The only disadvantages to the laparoscopic approach were slightly increased operative time for both procedures, and increased emesis following LAL.

Biologic Prosthesis Reduces Recurrence After Laparoscopic Paraesophageal Hernia Repair: A Multicenter, Prospective, Randomized Trial

Objective:Laparoscopic paraesophageal hernia repair (LPEHR) is associated with a high recurrence rate. Repair with synthetic mesh lowers recurrence but can cause dysphagia and visceral erosions. This trial was designed to study the value of a biologic prosthesis, small intestinal submucosa (SIS), in LPEHR. Methods:Patients undergoing LPEHR (n = 108) at 4 institutions were randomized to primary repair −1° (n = 57) or primary repair buttressed with SIS (n = 51) using a standardized technique. The primary outcome measure was evidence of recurrent hernia (≥2 cm) on UGI, read by a study radiologist blinded to the randomization status, 6 months after operation. Results:At 6 months, 99 (93%) patients completed clinical symptomatic follow-up and 95 (90%) patients had an UGI. The groups had similar clinical presentations (symptom profile, quality of life, type and size of hernia, esophageal length, and BMI). Operative times (SIS 202 minutes vs. 1° 183 minutes, P = 0.15) and perioperative complications did not differ. There were no operations for recurrent hernia nor mesh-related complications. At 6 months, 4 patients (9%) developed a recurrent hernia >2 cm in the SIS group and 12 patients (24%) in the 1° group (P = 0.04). Both groups experienced a significant reduction in all measured symptoms (heartburn, regurgitation, dysphagia, chest pain, early satiety, and postprandial pain) and improved QOL (SF-36) after operation. There was no difference between groups in either pre or postoperative symptom severity. Patients with a recurrent hernia had more chest pain (2.7 vs. 1.0, P = 0.03) and early satiety (2.8 vs. 1.3, P = 0.02) and worse physical functioning (63 vs. 72, P = 0.03 per SF-36). Conclusions:Adding a biologic prosthesis during LPEHR reduces the likelihood of recurrence at 6 months, without mesh-related complications or side effects.

General surgery residency inadequately prepares trainees for fellowship: results of a survey of fellowship program directors.

Objective:To assess readiness of general surgery graduate trainees entering accredited surgical subspecialty fellowships in North America. Methods:A multidomain, global assessment survey designed by the Fellowship Council research committee was electronically sent to all subspecialty program directors. Respondents spanned minimally invasive surgery, bariatric, colorectal, hepatobiliary, and thoracic specialties. There were 46 quantitative questions distributed across 5 domains and 1 or more reflective qualitative questions/domains. Results:There was a 63% response rate (n = 91/145). Of respondent program directors, 21% felt that new fellows arrived unprepared for the operating room, 38% demonstrated lack of patient ownership, 30% could not independently perform a laparoscopic cholecystectomy, and 66% were deemed unable to operate for 30 unsupervised minutes of a major procedure. With regard to laparoscopic skills, 30% could not atraumatically manipulate tissue, 26% could not recognize anatomical planes, and 56% could not suture. Furthermore, 28% of fellows were not familiar with therapeutic options and 24% were unable to recognize early signs of complications. Finally, it was felt that the majority of new fellows were unable to conceive, design, and conduct research/academic projects. Thematic clustering of qualitative data revealed deficits in domains of operative autonomy, progressive responsibility, longitudinal follow-up, and scholarly focus after general surgery education.

Feasibility of radical sigmoid colectomy performed as natural orifice translumenal endoscopic surgery (NOTES) using transanal endoscopic microsurgery

BackgroundNatural orifice translumenal endoscopic surgery (NOTES), a recent development in the field of minimally invasive surgery, may offer advantages over open and laparoscopic surgery. Most investigations to date have focused on small end-organ resections, and none have described en bloc regional lymphadenectomy. This study aimed to describe a method of anal transcolonic sigmoid colon resection.MethodsA fresh frozen then thawed cadaver model was used. Three male human cadavers were subjected to transanal sigmoid colon mobilization, high vascular ligation, en bloc lymphadenectomy, and stapled end-to-end anastomosis performed by a single operator using transanal endoscopic microsurgery instrumentation.ResultsThe findings showed that NOTES sigmoid colon resection with en bloc lymphadenectomy and primary anastomosis can be performed successfully. The critical steps of the procedure were (1) luminal suture occlusion of the sigmoid colon, (2) transrectal bowel division, (3) entry through the mesorectum into the presacral space, (4) en bloc mobilization of the sigmoid colon mesentery off of the retroperitoneum, (5) high ligation of the superior hemorrhoidal artery, (6) transanal delivery of the intact sigmoid colon specimen, (7) extracorporeal division of the colon, and (8) creation of a stapled end-to-end colorectal anastomosis. Postprocedure laparotomy confirmed adequate lymphadenectomy and anastomosis with no untoward events.ConclusionsIt is possible to complete the critical steps of a NOTES sigmoid resection, en bloc lymphadenectomy, primary anastomosis, and retrieval of an intact specimen without any incisions using transanal endoscopic microsurgery instrumentation.

Dysphagia after laparoscopic antireflux surgery. The impact of operative technique.

BACKGROUND Concerns about laparoscopic antireflux surgery include the frequent appearance of troublesome postoperative dysphagia. This study reviews the frequency of early (less than 6 weeks) and persistent (greater than 6 weeks) solid food dysphagia in patients undergoing Toupet, Rosetti-Nissen, or Nissen fundoplications. METHODS One hundred eighty-four consecutive patients with normal esophageal peristalsis undergoing laparoscopic antireflux surgery were prospectively studied. Before operation, all patients had endoscopy, 24-hour pH study, and an esophageal motility study. The choice of operation was dependent on anatomy and surgeon preference. Before discharge, all patients were given instructions on a soft diet. Postoperative symptoms were scored by the patients as absent, mild, moderate, or severe 4 weeks and 12 weeks after operation. The option of esophageal dilation was offered to patients with moderate to severe persistent solid food dysphagia. RESULTS New onset moderate to severe dysphagia to solid foods was present in 30 (54%), 8 (17%), and 13 (16%) patients undergoing Rosetti-Nissen, Nissen, and Toupet fundoplications, respectively, in the first month after operation (p < 0.001). Moderate to severe dysphagia persisted at 3 months in six (11%), one (2%), and two (2%) patients undergoing laparoscopic Rosetti-Hell, Nissen, and Toupet fundoplications, respectively (p < 0.05). Esophageal dilatation was performed in five (4%), zero, and one (1%) patients undergoing laparoscopic Rosetti-Nissen, Nissen, and Toupet fundoplications, respectively (p < 0.05). There was no additional morbidity related to division of short gastric vessels in patients undergoing Nissen fundoplication. CONCLUSIONS Laparoscopic Rosetti-Nissen fundoplication is associated with a higher rate of early and persistent postoperative dysphagia than either laparoscopic Nissen fundoplication or Toupet fundoplication. Consideration of complete fundus mobilization should be a part of all laparoscopic antireflux procedures.

Development of a new access device for transgastric surgery.

Flexible endoscope-based endoluminal and transgastric surgery for cholecystectomy, appendectomy, bariatric, and antireflux procedures show promise as a less invasive form of surgery. Current endoscopes and instruments are inadequate to perform such complex surgeries for a variety of reasons: they are too flexible and are insufficient to provide robust grasping and anatomic retraction. The lack of support for a retroflexed endoscope in the peritoneal cavity makes it hard to reach remote structures and makes vigorous retraction of tissues and organs difficult. There is also a need for multiple channels in scopes to allow use of several instruments and to provide traction/countertraction. Finally, secure means of tissue approximation are critical. The aim was to develop and test a new articulating flexible endoscopic system for endoluminal and transgastric endosurgery. A multidisciplinary group of gastrointestinal physicians and surgeons worked with medical device engineers to develop new devices and instruments. Needs assessments and design parameters were developed by consensus. Prototype devices were tested using inanimate models until usable devices were arrived at. The devices were tested in nonsurvival pigs and dogs. The devices were accessed through an incision in the wall of the stomach and manipulated in the peritoneal cavity to accomplish four different tasks: right upper quadrant wedge liver biopsy, right lower quadrant cecal retraction, left lower quadrant running small bowel, and left lower quadrant exposure of esophageal hiatus. In another three pigs, transgastric cholecystectomy was attempted. The positions of the device, camera, and endosurgical instruments, with and without ShapeLock technology, were recorded using laparoscopy and endoscopy and procedure times and success rates were measured. Instrument design parameters and their engineering solutions are described. Flexible multilumen guides which could be locked in position, including a prototype which allowed triangulation, were constructed. Features of the 18-mm devices include multidirectional mid body and/or tip angulation, two 5.5-mm accessory channels allowing the use of large (5-mm) flexible endosurgical instruments, as well as a 4-mm channel for an ultraslim prototype video endoscope (Pentax 4 mm). Using the resulting devices, the four designated transgastric procedures were performed in anesthetized animals. One hundred percent of the transgastric endosurgical procedures were accomplished with the exception of a 50% success for hiatal exposure, a 90% success rate for wedge liver biopsy, and a 33.3% success rate for cholecystectomy. A new endosurgical multilumen device and advanced instrumentation allowed effective transgastric exploration and procedures in the abdominal cavity including retraction of the liver and stomach to allow exposure of the gallbladder, retraction of the cecum, manipulation of the small bowel, and exposure of the esophageal hiatus. This technology may serve as the needed platform for transgastric cholecystectomy, gastric reduction, fundoplication, hiatus hernia repair, or other advanced endosurgical procedures.

Endoluminal Methods for Gastrotomy Closure in Natural Orifice TransEnteric Surgery (NOTES)

Natural orifice transenteric surgery (NOTES) is a new and rapidly evolving concept for intra-abdominal operations that offers the potential for a revolutionary advance in patient care. Conceptually, operations that currently require an open or laparoscopic approach could be performed without incisions in the abdomen, with their concomitant pain and scarring. A recent consensus statement by a joint group of gastrointestinal surgeons and gastroenterologists has identified several technical and technologic hurdles that would need to be overcome before NOTES becomes a clinical reality. One of the most significant requirements identified is the need for a very secure closure of the gastrotomy site that is required for scope passage and specimen removal. Although a rapidly expanding variety of transgastric procedures has been reported, only a few reports address the basic problem of gastrotomy closure. Availability of a safe and simple gastrotomy closure device, however, will be essential for the widespread adoption of the new field of NOTES. Unless new safe and simple devices for endoscopic gastrotomy closure are available and have proven efficacy, NOTES will remain in the hands of a few specialists at centers of excellence because the risk of complications due to insufficient gastrotomy closure will not be acceptable for the surgeon and gastroenterologist in general practice. In this article, we describe three new devices in development or newly on the market that are targeted to advance the safe endoscopic closure of gastrotomy from NOTES.

Long-term outcomes of an endoscopic myotomy for achalasia: the POEM procedure.

Background:Esophageal achalasia is most commonly treated with laparoscopic myotomy or endoscopic dilation. Per-oral endoscopic myotomy (POEM), an incisionless selective myotomy, has been described as a less invasive surgical treatment. This study presents 6-month physiological and symptomatic outcomes after POEM for achalasia. Methods:Data on single-institution POEMs were collected prospectively. Pre- and postoperative symptoms were quantified with Eckardt scores. Objective testing (manometry, endoscopy, timed-barium swallow) was performed preoperatively and 6 months postoperatively. At 6 months, gastroesophageal reflux was evaluated by 24-hour pH testing. Pre-/postmyotomy data were compared using paired nonparametric statistics. Results:Eighteen achalasia patients underwent POEMs between October 2010 and October 2011. The mean age was 59 ± 20 years and mean body mass index was 26 ± 5 kg/m2. Six patients had prior dilations or Botox injections. Myotomy length was 9 cm (7–12 cm), and the median operating time was 135 minutes (90–260). There were 3 intraoperative complications: 2 gastric mucosotomies and 1 full-thickness esophagotomy, all repaired endoscopically with no sequelae. The median hospital stay was 1 day and median return to normal activity was 3 days (3–9 days). All patients had relief of dysphagia [dysphagia score ⩽ 1 (“rare”)]. Only 2 patients had Eckardt scores greater than 1, due to persistent noncardiac chest pain. At a mean follow-up of 11.4 months, dysphagia relief persisted for all patients. Postoperative manometry and timed barium swallows showed significant improvements in lower esophageal relaxation characteristics and esophageal emptying, respectively. Objective evidence of gastroesophageal reflux was seen in 46% patients postoperatively. Conclusions:POEM is safe and effective. All patients had dysphagia relief, 83% having relief of noncardiac chest pain. There is significant though mild gastroesophageal reflux postoperatively in 46% of patients in 6-month pH studies. The lower esophageal sphincter shows normalized pressures and relaxation.

Biologic Prosthesis to Prevent Recurrence after Laparoscopic Paraesophageal Hernia Repair: Long-term Follow-up from a Multicenter, Prospective, Randomized Trial

BACKGROUND In 2006, we reported results of a randomized trial of laparoscopic paraesophageal hernia repair (LPEHR), comparing primary diaphragm repair (PR) with primary repair buttressed with a biologic prosthesis (small intestinal submucosa [SIS]). The primary endpoint, radiologic hiatal hernia (HH) recurrence, was higher with PR (24%) than with SIS buttressed repair (9%) after 6 months. The second phase of this trial was designed to determine the long-term durability of biologic mesh-buttressed repair. METHODS We systematically searched for the 108 patients in phase I of this study to assess current clinical symptoms, quality of life (QOL) and determine ongoing durability of the repair by obtaining a follow-up upper gastrointestinal series (UGI) read by 2 radiologists blinded to treatment received. HH recurrence was defined as the greatest measured vertical height of stomach being at least 2 cm above the diaphragm. RESULTS At median follow-up of 58 months (range 42 to 78 mo), 10 patients had died, 26 patients were not found, 72 completed clinical follow-up (PR, n = 39; SIS, n = 33), and 60 repeated a UGI (PR, n = 34; SIS, n = 26). There were 20 patients (59%) with recurrent HH in the PR group and 14 patients (54%) with recurrent HH in the SIS group (p = 0.7). There was no statistically significant difference in relevant symptoms or QOL between patients undergoing PR and SIS buttressed repair. There were no strictures, erosions, dysphagia, or other complications related to the use of SIS mesh. CONCLUSIONS LPEHR results in long and durable relief of symptoms and improvement in QOL with PR or SIS. There does not appear to be a higher rate of complications or side effects with biologic mesh, but its benefit in reducing HH recurrence diminishes at long-term follow-up (more than 5 years postoperatively) or earlier.