Development and preliminary validation of a new task-based objective procedure-specific assessment of inguinal hernia repair procedural safety.

BACKGROUND: Surgical videos coupled with structured assessments enable surgical training programs to provide independent competency evaluations and align with the American Board of Surgery's entrustable professional activities initiative. Existing assessment instruments for minimally invasive inguinal hernia repair (IHR) have limitations with regards to reliability, validity, and usability. A cross-sectional study of six surgeons using a novel objective, procedure-specific, 8-item competency assessment for minimally invasive inguinal hernia repair (IHR-OPSA) was performed to assess inter-rater reliability using a "safe" vs. "unsafe" scoring rubric. METHODS: The IHR-OPSA was developed by three expert IHR surgeons, field tested with five IHR surgeons, and revised based upon feedback. The final instrument included: (1) incision/port placement; (2) dissection of peritoneal flap (TAPP) or dissection of peritoneal flap (TEP); (3) exposure; (4) reducing the sac; (5) full dissection of the myopectineal orifice; (6) mesh insertion; (7) mesh fixation; and (8) operation flow. The IHR-OPSA was applied by six expert IHR surgeons to 20 IHR surgical videos selected to include a spectrum of hernia procedures (15 laparoscopic, 5 robotic), anatomy (14 indirect, 5 direct, 1 femoral), and Global Case Difficulty (easy, average, hard). Inter-rater reliability was assessed against Gwet's AC2. RESULTS: The IHR-OPSA inter-rater reliability was good to excellent, ranging from 0.65 to 0.97 across the eight items. Assessments of robotic procedures had higher reliability with near perfect agreement for 7 of 8 items. In general, assessments of easier cases had higher levels of agreement than harder cases. CONCLUSIONS: A novel 8-item minimally invasive IHR assessment tool was developed and tested for inter-rater reliability using a "safe" vs. "unsafe" rating system with promising results. To promote instrument validity the IHR-OPSA was designed and evaluated within the context of intended use with iterative engagement with experts and testing of constructs against real-world operative videos.

Long-Term, Prospective, Multicenter Study of Poly-4-Hydroxybutyrate Mesh (Phasix Mesh) for Hernia Repair in Cohort at Risk for Complication: 60-Month Follow-Up.

BACKGROUND: Long-term resorbable mesh represents a promising technology for ventral and incisional hernia repair (VIHR). This study evaluates poly-4-hydroxybutyrate mesh (P4HB; Phasix Mesh) among comorbid patients with CDC class I wounds. STUDY DESIGN: This prospective, multi-institutional study evaluated P4HB VIHR in comorbid patients with CDC class I wounds. Primary outcomes included hernia recurrence and surgical site infection. Secondary outcomes included pain, device-related adverse events, quality of life, reoperation, procedure time, and length of stay. Evaluations were scheduled at 1, 3, 6, 12, 18, 24, 30, 36, and 60 months. A time-to-event analysis (Kaplan-Meier) was performed for primary outcomes; secondary outcomes were reported as descriptive statistics. RESULTS: A total of 121 patients (46 male, 75 female) 54.7 ± 12.0 years old with a BMI of 32.2 ± 4.5 kg/m 2 underwent VIHR with P4HB Mesh (mean ± SD). Fifty-four patients (44.6%) completed the 60-month follow-up. Primary outcomes (Kaplan-Meier estimates at 60 months) included recurrence (22.0 ± 4.5%; 95% CI 11.7% to 29.4%) and surgical site infection (10.1 ± 2.8%; 95% CI 3.3 to 14.0). Secondary outcomes included seroma requiring intervention (n = 9), procedure time (167.9 ± 82.5 minutes), length of stay (5.3 ± 5.3 days), reoperation (18 of 121, 14.9%), visual analogue scale-pain (change from baseline -3.16 ± 3.35 cm at 60 months; n = 52), and Carolinas Comfort Total Score (change from baseline -24.3 ± 21.4 at 60 months; n = 52). CONCLUSIONS: Five-year outcomes after VIHR with P4HB mesh were associated with infrequent complications and durable hernia repair outcomes. This study provides a framework for anticipated long-term hernia repair outcomes when using P4HB mesh.

SAGES white paper on the current state of community practice surgeons: re-discovering the value of our community practice surgeons.

BACKGROUND: The Community Practice (CP) surgeon is the first point of access to surgical care globally and performs the majority of procedures in the USA. CP surgeons include those of various practice models, locations and communities, education and training, and much more. It is a diverse group that drives quality, access to care, research, and innovation. The SAGES CP Committee was formed to better define the role and highlight the contribution of the CP surgeon, as well as advocate for the position of CP surgeons in our society. METHODS: In 2018, a survey was distributed to the SAGES membership asking members to self-identify as either a Community Surgeon or Academic Surgeon. RESULTS: The majority (71%) of SAGES members surveyed self-identified as "Community Surgeons." This was in stark contrast to the distribution of Community versus Academic Surgeons in SAGES leadership (25% versus 75%, respectively). CONCLUSION: By better defining the characteristics and role of the CP, SAGES will be better informed on how to effectively engage with this large group within the society and increase its representation within the leadership. The CP Committee met on a biannual basis over a period of two years focusing on assessing their role in the SAGES organization. The committee members created the following initial goals: (1) define in a broad sense the characteristics of a CP Surgeon, (2) discuss and characterize the value of the CP surgeons, (3) highlight past and future areas of contributions of the group, and (4) delineate ways to engage and represent this subgroup. This manuscript is a culmination of the work of this committee while also serving as a way to support the initiatives and direction of SAGES leadership.

Prospective, multicenter study of P4HB (Phasix™) mesh for hernia repair in cohort at risk for complications: 3-Year follow-up.

BACKGROUND: This study represents a prospective, multicenter, open-label study to assess the safety, performance, and outcomes of poly-4-hydroxybutyrate (P4HB, Phasix™) mesh for primary ventral, primary incisional, or multiply-recurrent hernia in subjects at risk for complications. This study reports 3-year clinical outcomes. MATERIALS AND METHODS: P4HB mesh was implanted in 121 patients via retrorectus or onlay technique. Physical exam and/or quality of life surveys were completed at 1, 3, 6,12, 18, 24, and 36 months, with 5-year (60-month) follow-up ongoing. RESULTS: A total of n = 121 patients were implanted with P4HB mesh (n = 75 (62%) female) with a mean age of 54.7 ± 12.0 years and mean BMI of 32.2 ± 4.5 kg/m2 (±standard deviation). Comorbidities included: obesity (78.5%), active smokers (23.1%), COPD (28.1%), diabetes mellitus (33.1%), immunosuppression (8.3%), coronary artery disease (21.5%), chronic corticosteroid use (5.0%), hypo-albuminemia (2.5%), advanced age (5.0%), and renal insufficiency (0.8%). Hernias were repaired via retrorectus (n = 45, 37.2% with myofascial release (MR) or n = 43, 35.5% without MR), onlay (n = 8, 6.6% with MR or n = 24, 19.8% without MR), or not reported (n = 1, 0.8%). 82 patients (67.8%) completed 36-month follow-up. 17 patients (17.9% ± 0.4%) experienced hernia recurrence at 3 years, with n = 9 in the retrorectus group and n = 8 in the onlay group. SSI (n = 11) occurred in 9.3% ± 0.03% of patients. CONCLUSIONS: Long-term outcomes following ventral hernia repair with P4HB mesh demonstrate low recurrence rates at 3-year (36-month) postoperative time frame with no patients developing late mesh complications or requiring mesh removal. 5-year (60-month) follow-up is ongoing.

Robotic-Assisted Laparoscopic Ventral Hernia Repair.

Robotic-assisted laparoscopic ventral hernia repair (RA-LVHR) has many options. Before applying these techniques, it is important to identify the patient's goals for hernia repair, align yourself with those goals, and apply a technique appropriate for the clinical scenario, and most likely to meet the goals. Fundamental principles of hernia repair must be maintained: avoiding thermal injury to hollow viscera, adequate dissection of abdominal wall, appropriate mesh:defect ratio, stronger fixation where overlap is limited, and more overlap where fixation points are weak. This manuscript will detail available techniques for RA-LVHR along with their their advantages and disadvantages.

Utilising the Delphi Process to Develop a Proficiency-based Progression Train-the-trainer Course for Robotic Surgery Training.

CONTEXT: As the role of robot-assisted surgery continues to expand, development of standardised and validated training programmes is becoming increasingly important. OBJECTIVE: To provide guidance on an optimised "train-the-trainer" (TTT) structured educational programme for surgical trainers, in which delegates learn a standardised approach to training candidates in skill acquisition. We aim to describe a TTT course for robotic surgery based on the current published literature and to define the key elements within a TTT course by seeking consensus from an expert committee formed of key opinion leaders in training. EVIDENCE ACQUISITION: The project was carried out in phases: a systematic review of the current evidence was conducted, a face-to-face meeting was held in Philadelphia, and then an initial survey was created based on the current literature and expert opinion and sent to the committee. Thirty-two experts in training, including clinicians, academics, and industry, contributed to the Delphi process. The Delphi process underwent three rounds of survey in total. Additions to the second- and third-round surveys were formulated based on the answers and comments from the previous rounds. Consensus opinion was defined as ≥80% agreement. EVIDENCE SYNTHESIS: There was 100% consensus that there was a need for a standardized TTT course in robotic surgery. A consensus was reached in multiple areas, including the following: (1) definitions and terminologies, (2) qualifications to attend, (3) course objectives, (4) precourse considerations, (5) requirement of e-learning, (6) theory and course content, and (7) measurement of outcomes and performance level verification. The resulting formulated curriculum showed good internal consistency among experts, with a Cronbach alpha of 0.90. CONCLUSIONS: Using the Delphi methodology, we achieved an international consensus among experts to develop and reach content validation for a standardised TTT curriculum for robotic surgery training. This defined content lays the foundation for developing a proficiency-based progression model for trainers in robotic surgery. This TTT curriculum will require further validation. PATIENT SUMMARY: As the role of robot-assisted surgery continues to expand, development of standardised and validated training programmes is becoming increasingly important. There is currently a lack of high-level evidence on how best to train trainers in robot-assisted surgery. We report a consensus view on a standardised "train-the trainer" curriculum focused on robotic surgery. It was formulated by training experts from the USA and Europe, combining current evidence for training with experts' knowledge of surgical training.

Prospective evaluation of poly-4-hydroxybutyrate mesh in CDC class I/high-risk ventral and incisional hernia repair: 18-month follow-up.

BACKGROUND: Long-term resorbable mesh represents a promising technology for complex ventral and incisional hernia repair (VIHR). Preclinical studies indicate that poly-4-hydroxybutyrate (P4HB) resorbable mesh supports strength restoration of the abdominal wall. This study evaluated outcomes of high-risk subjects undergoing VIHR with P4HB mesh. METHODS: This was a prospective, multi-institutional study of subjects undergoing retrorectus or onlay VIHR. Inclusion criteria were CDC Class I, defect 10-350 cm2, ≤ 3 prior repairs, and ≥ 1 high-risk criteria (obesity (BMI: 30-40 kg/m2), active smoker, COPD, diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, hypoalbuminemia, advanced age, and renal insufficiency). Physical exam and/or quality of life surveys were performed at regular intervals through 18 months (to date) with longer-term, 36-month follow-up ongoing. RESULTS: One hundred and twenty-one subjects (46M, 75F) with an age of 54.7 ± 12.0 years and BMI of 32.2 ± 4.5 kg/m2 (mean ± SD), underwent VIHR. Comorbidities included the following: obesity (n = 95, 78.5%), hypertension (n = 72, 59.5%), cardiovascular disease (n = 42, 34.7%), diabetes (n = 40, 33.1%), COPD (n = 34, 28.1%), malignancy (n = 30, 24.8%), active smoker (n = 28, 23.1%), immunosuppression (n = 10, 8.3%), chronic corticosteroid use (n = 6, 5.0%), advanced age (n = 6, 5.0%), hypoalbuminemia (n = 3, 2.5%), and renal insufficiency (n = 1, 0.8%). Hernia types included the following: primary ventral (n = 17, 14%), primary incisional (n = 54, 45%), recurrent ventral (n = 15, 12%), and recurrent incisional hernia (n = 35, 29%). Defect and mesh size were 115.7 ± 80.6 and 580.9 ± 216.1 cm2 (mean ± SD), respectively. Repair types included the following: retrorectus (n = 43, 36%), retrorectus with additional myofascial release (n = 45, 37%), onlay (n = 24, 20%), and onlay with additional myofascial release (n = 8, 7%). 95 (79%) subjects completed 18-month follow-up to date. Postoperative wound infection, seroma requiring intervention, and hernia recurrence occurred in 11 (9%), 7 (6%), and 11 (9%) subjects, respectively. CONCLUSIONS: High-risk VIHR with P4HB mesh demonstrated positive outcomes and low incidence of hernia recurrence at 18 months. Longer-term 36-month follow-up is ongoing.

The NOVEL trial: natural orifice versus laparoscopic cholecystectomy-a prospective, randomized evaluation.

INTRODUCTION: The evolution of Natural Orifice Translumenal Endoscopic Surgery® (NOTES®) represents a case study in surgical procedural evolution. Beginning in 2004 with preclinical feasibility studies, and followed by the creation of the NOSCAR® collaboration between The Society of American Gastrointestinal and Endoscopic Surgeons and the American Society for Gastrointestinal Endoscopy, procedural development followed a stepwise incremental pathway. The work of this consortium has included white paper analyses, obtaining outside independent funding for basic science and procedural development, and, ultimately, the initiation of a prospective randomized clinical trial comparing NOTES® cholecystectomy as an alternative procedure to laparoscopic cholecystectomy. METHODS: Ninety patients were randomized into a randomized clinical trial with the primary objective of demonstrating non-inferiority of the transvaginal and transgastric arms to the laparoscopic arm. In the original trial design, there were both transgastric and transvaginal groups to be compared to the laparoscopic control group. However, after enrollment and randomization of 6 laparoscopic controls and 4 transgastric cases into the transgastric group, this arm was ultimately deemed not practical due to lagging enrollment, and the arm was closed. Three transgastric via the transgastric approach were performed in total with 9 laparoscopic control cases enrolled through the TG arm. Overall a total of 41 transvaginal and their 39 laparoscopic cholecystectomy controls were randomized into the study with 37 transvaginal and 33 laparoscopic cholecystectomies being ultimately performed. Overall total operating time was statistically longer in the NOTES® group: 96.9 (64.97) minutes versus 52.1 (19.91) minutes. RESULTS: There were no major adverse events such as common bile duct injury or return to the operating room for hemorrhage. Intraoperative blood loss, length of stay, and total medication given in the PACU were not statistically different. There were no conversions in the NOTES® group to a laparoscopic or open procedure, nor were there any injuries, bile leaks, hemorrhagic complications, wound infections, or wound dehiscence in either group. There were no readmissions. Visual Analogue Scale (VAS) pain scores were 3.4 (CI 2.82) in the laparoscopic group and 2.9 (CI 1.96) in the transvaginal group (p = 0.41). The clinical assessment on cosmesis scores was not statistically different when recorded by clinical observers for most characteristics measured when the transvaginal group was compared to the laparoscopic group. Taken as a whole, the results slightly favor the transvaginal group. SF-12 scores were not statistically different at all postoperative time points except for the SF-12 mental component which was superior in the transvaginal group at all time points (p < 0.05). CONCLUSION: The safety profile for transvaginal cholecystectomy demonstrates that this approach is safe and produces at least non-inferior clinical results with superior cosmesis, with a transient reduction in discomfort. The transvaginal approach to cholecystectomy should no longer be considered experimental. As a model for intersociety collaboration, the study demonstrated the ultimate feasibility and success of partnership as a model for basic research, procedural development, fundraising, and clinical trial execution for novel interventional concepts, regardless of physician board certification.

Development of a rapid response plan for intraoperative emergencies: the Circulate, Scrub, and Technical Assistance Team.

BACKGROUND: Unplanned intraoperative events are inevitable and cause stress and inefficiency among staff. We believe that developing a technical rapid response team with explicitly defined, narrow roles would reduce the amount of chaos during such emergencies. This article provides a detailed description of the development and implementation of such a program. METHODS: In-situ simulation of an intraoperative emergency was used for a formal assessment of the current practice. Debriefing sessions identified areas of improvement and solicited solutions. A multidisciplinary working group then developed and implemented the technical rapid response team based on the needs assessment. The program was designed to create a Circulating, Scrubbing, and Technical Assistance Team that helps with equipment, supplies, anesthesia, and communication. RESULTS: We anticipate the program will foster a culture of safety, and promote positive relationships and attitudes of the entire multidisciplinary team. CONCLUSIONS: In the future, research regarding patient outcomes and staff satisfaction and safety attitudes may help provide objective evidence of the benefits of the program.

Repair of umbilical and epigastric hernias.

Umbilical and epigastric hernias are primary midline defects that are present in up to 50% of the population. In the United States, only about 1% of the population carries this specific diagnosis, and only about 11% of these are repaired. Repair is aimed at symptoms relief or prevention, and the patient's goals and expectations should be explicitly identified and aligned with the health care team. This article details some relevant and interesting anatomic issues, reviews existing data, and highlights some common and important surgical techniques. Emphasis is placed on a patient-centered approach to the repair of umbilical and epigastric hernias.

NOTES(®) stapled cystgastrostomy: a novel approach for surgical management of pancreatic pseudocysts.

BACKGROUND: Traditional approach for surgical management of mature pancreatic pseudocysts is by internal surgical drainage. Endoscopic drainage procedures have also been described. We describe Natural Orifice Translumenal Endoscopic Surgery (NOTES(®)) stapled cystgastrostomy as a less invasive surgical procedure. STUDY DESIGN: Case series. METHODS: NOTES(®) cystgastrostomy was performed in six patients with mature pseudocysts from June 2007 to July 2009 under institutional review board (IRB) protocol. The size of the pseudocysts varied from 8 to 23 cm, and all of the pseudocysts were considered complex pseudocysts. The operative team included two general surgeons and a gastroenterologist. The procedure included endoscopic ultrasound (EUS)-guided puncture of the stomach just below the gastroesophageal (GE) junction to gain access to the pseudocyst, guidewire placement, and then dilatation with a balloon to 18-20 mm. Endoscopic necrosectomy and debridement were performed when possible, followed by transoral surgical anastomosis under endoscopic visualization with the SurgAssist™ SLC 55 (Power Medical Interventions, Langhorne, PA) 4.8-mm stapler. Anastomotic length varied from 5.5 to 8 cm. In one patient, diagnostic laparoscopy was performed after the procedure due to inadvertent pneumoperitoneum; no leak or perforation was identified. RESULTS: Length of stay varied between 2 and 14 days. All patients had routine esophagogastroduodenoscopy (EGD) at 1 and 6 weeks postoperatively to evaluate patency; computed tomography (CT) scan was done at 2-3 months to demonstrate resolution of the pseudocyst. All patients had significant decrease in pseudocyst size with patent anastomosis on postoperative EGD, although one patient required endoscopic anastomotic dilatation due to continued symptoms 6 weeks after the operation. Her pseudocyst completely resolved 4 months postoperatively. An additional patient required subsequent distal pancreatectomy due to recurrent symptoms of chronic pancreatitis. CONCLUSION: NOTES(®) cystgastrostomy is comparable to previously described surgical approaches, yet is as minimally invasive as endoscopic drainage procedures previously described for management of pseudocysts. It is less invasive than laparoscopic or open cystgastrostomy, yet provides definitive treatment.

Gastrotomy closure with the lock-it system and the Padlock-G clip: a survival study in a porcine model.

BACKGROUND AND STUDY AIMS: The success of natural orifice surgery depends on secure closure of the transmural gut opening, so a rapid, secure, and easy-to-place closure method is desirable. Our aim was to determine whether a gastrotomy can be closed safely and effectively from within the stomach in a survival model by using a novel, endoscopically placed device: the Padlock-G system. PATIENTS AND METHODS: This was a pilot study of 4 survival animals in an animal laboratory setting. Gastrotomies were made in the stomachs of laboratory swine, and the abdomen was explored by using a standard gastroscope. Gastrotomies were then closed by using the Padlock-G system. Survival for 2 or 6 weeks was the primary outcome measurement. Secondary outcomes included ease of use, visual assessment of closure integrity immediately and at necropsy, presence of adhesions, evidence of infection, and histologic appearance at the closure sites. RESULTS: All animals thrived, ate normally, and gained weight. None developed fever, tachycardia, or signs of peritoneal irritation. Closure-site inspection at necropsy revealed excellent healing, with epithelial growth over the Padlock-G. There were no ulcers, serosal surfaces were tightly closed, and no defects could be seen. There were no signs of peritoneal inflammation, intra-abdominal adhesions, or gastric spillage. Histologic evaluation showed organizing granulation tissue with fibrosis, vascular proliferation, and mild chronic inflammatory infiltrate (i.e., scar). CONCLUSIONS: The Padlock-G is easy to place, provides a durable closure, and allows survival animals to thrive without adverse sequellae. This device provides a suitable closure system for transgastric NOTES.

Loop-anchor purse-string closure of gastrotomy in NOTES(R) procedures: survival studies in a porcine model.

INTRODUCTION: Transgastric NOTES(®) procedures remain without a simple method to close the gastrotomy. In four survival swine studies, we have tested a novel gastric closure device: the loop-anchor purse-string (LAPS) closure system. METHODS: In four anesthetized pigs, an endoscopic gastrotomy was performed. Four loop anchors were arrayed in a 2-cm square pattern around the gastrotomy. The endoscope was passed into the abdominal cavity, and the gastrotomy was cinched closed. RESULTS: Procedure times ranged from 50-180 minutes. Three pigs survived 14 days. One animal was sacrificed early due to signs of sepsis. Another animal developed fevers and was treated with antibiotics. At necropsy, there were no abscesses, including in the septic animal. Histologic examination revealed evidence of healing in all animals. DISCUSSION: The LAPS system holds promise with early success in an animal model. Future human studies are needed to determine viability as a human visceral closure device.

Gastric transmural pressure measurements in vivo: implications for natural orifice transluminal endoscopic surgery (NOTES).

BACKGROUND: The success of natural orifice surgery depends on a reliable, secure closure of the opening in the gut. Forces that might be exerted on the gastric wall to disrupt closure have not been measured in humans or animals. OBJECTIVE: To determine how transmural gastric pressure gradients vary under different experimental conditions. DESIGN: In vivo porcine model. SETTING: Animal laboratory. PATIENTS: Eleven laboratory pigs. INTERVENTIONS: Pressure transducers were placed in the abdomen and stomachs of the test animals. Simultaneous pressure measurements were obtained to determine the stresses applied to the gastric wall during various maneuvers. MAIN OUTCOME MEASUREMENTS: Continuous intra-abdominal and intragastric pressures in vivo. Transgastric pressure gradients (DeltaP) were computed in real time by subtracting gastric pressure from abdominal pressure. RESULTS: In all cases, the measured gastric pressures were nearly identical to those measured in the abdominal cavity because the stomach is entirely contained within the abdomen. The transmural gastric pressure gradients were near zero during a variety of experimental conditions. LIMITATION: Anesthetized animal model, not engaged in usual activities. Relatively low pressures generated during a cough sequence and a Valsalva maneuver compared with reported values in the literature. CONCLUSION: Estimates of gastric pressures that must be tolerated by gastric closure devices after natural orifice transluminal endoscopic surgery procedures have been greatly overestimated. Absolute gastric pressure is counteracted by external (intra-abdominal) pressure such that the net transmural gastric pressure gradient remains near zero under a variety of conditions.

Single-port laparoscopic cholecystectomy: initial experience.

BACKGROUND: As surgeons embrace the concept of increasingly less invasive surgery, techniques using only a single small incision have begun to gain traction. Several commercially available products have emerged recently. The TriPort system and the SILS Port are single-port devices that allow the surgeon to perform laparoscopic surgery through a 2- to 3-cm periumbilical incision. This study aimed to ascertain whether these devices allow safe and reliable access for laparoscopic cholecystectomy. METHODS: From March 2008 to June 2009, single-port laparoscopic cholecystectomy was attempted for 22 patients with an average age of 40 years (range, 23-73 years). The data collected prospectively after institutional review board approval included demographics, operative time, complications, and reasons for conversion to standard four-port laparoscopic surgery. RESULTS: The operation was completed successfully for 21 of the 22 patients (15 women and 7 men) using five different techniques. The mean body mass index (BMI) of the patients was 32.7 kg/cm(2) (range, 22.3-46.1 kg/cm(2)). Three of the patients had previously undergone laparoscopic Roux-en-Y gastric bypass. The mean operative time was 80.8 min (range, 51-156 min). One patient experienced a Richter's hernia postoperatively, which required a reoperation and subsequent bowel resection. One patient required conversion to a standard four-port laparoscopic cholecystectomy because the articulating instrument could not reach the gallbladder from the umbilicus. CONCLUSION: The results from the current series show single-port laparoscopic cholecystectomy to be a promising technique. A variety of patient demographics appear suited to this approach. The operative time in this series compares favorably with that for the standard four-port operation. The feasibility of single-port laparoscopic cholecystectomy is now established. However, routine application of this novel technique requires an evaluation of its safety and cost effectiveness in larger studies. In addition, its superiority over standard laparoscopic cholecystectomy in terms of postoperative pain, cosmesis, and overall patient satisfaction requires further study. Refinements in instrumentation will enable wider use of this novel minimally invasive approach.

Surgical resident performance on a virtual reality simulator correlates with operating room performance.

BACKGROUND: To define the ability of a virtual reality (VR) simulator to reflect clinical skill in surgical residents, we compared clinical laparoscopic performance and contemporary lab performance during curricular VR skills training. METHODS: Nine postgraduate year (PGY) 1 and 2 surgical residents were assessed during laparoscopic cholecystectomies and appendectomies using a web-based interactive database (OpRate)over a 6-mo period. Operative performance data were collected at the conclusion of procedures (mean responses of attending surgeons in nine areas pertaining to resident preparedness and technical skill). During this period, all residents undertook iterative laparoscopic training using a new VR trainer (SEP: SimSurgery AS, Oslo, Norway; METI, Sarasota FL). OpRate performance over 4-wk blocks and closest VR performance data (mean time, path length, and errors for three iterations of six basic skills tasks) were tested for correlation by linear (Pearson) correlation method. RESULTS: Residents performed 1 to 6 operative cases each (median = 3) during time blocks used for comparisons (median separation operative and SEP performance data 18 d). Significant correlation of operative and VR scores was found for time to task completion in 5 of 6 VR tasks. Results were most significant for a gallbladder dissection task (P = 0.0066, correlation coefficient = -0.6671). No significant correlation of path length or error data and operative performance was observed for any VR task. CONCLUSIONS: These data indicate that time to task completion on a VR training device correlates with resident performance in the clinical operating room. Serial evaluations will determine if concurrent performance improvement over time can be demonstrated.

Loop-anchor purse-string versus endoscopic clips for gastric closure: a natural orifice transluminal endoscopic surgery comparison study using burst pressures.

BACKGROUND: The success of natural orifice surgery depends on a reliable, secure closure of the opening in the gut. Few tests of the integrity of these closures have been published. OBJECTIVE: To determine whether a gastrotomy can be closed safely and effectively from within the stomach by using looped T-anchors-a novel, endoscopically placed device. DESIGN: Head-to-head comparison trial of 2 closure methods in 9 explanted porcine stomachs. SETTING: Animal laboratory. INTERVENTION: Paired gastrotomies were made in porcine explants. One was closed by using endoscopic clips, and the other was closed by using modified T-anchors in a purse-string fashion. MAIN OUTCOME MEASUREMENTS: Gastric transmural pressure gradients at bursting of these closures were measured while the explanted stomachs were inflated with a high-pressure insufflator. RESULTS: The mean burst pressure of the looped T-anchors was 27.3 mm Hg, whereas that of the clip closures was 14 mm Hg. By using 10 mm Hg as a threshold for a "secure" closure, 7 of 9 clip closures failed to meet the threshold value, whereas all 9 of the T-anchor closures met or exceeded the threshold value (P = .0023, 2-tailed Fisher exact test). LIMITATION: Nonsurvival study. CONCLUSION: Looped T-anchors provide a secure gastric closure for natural orifice surgery and are superior to endoscopic clips for this purpose.