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.

Global assessment of surgical skills (GASS): validation of a new instrument to measure global technical safety in surgical procedures.

BACKGROUND: Broad implementation of the American Board of Surgery's entrustable professional activities initiative will require assessment instruments that are reliable and easy to use. Existing assessment instruments of general laparoscopic surgical skills have limited reliability, efficiency, and validity across the spectrum of formative (low-stakes) and summative (high-stakes) assessments. A novel six-item global assessment of surgical skills (GASS) instrument was developed and evaluated with a focus upon safe versus unsafe surgical practice scoring rubric. METHODS: The GASS was developed by iterative engagement with expert laparoscopic surgeons and includes six items (economy of motion, tissue handling, appreciating operative anatomy, bimanual dexterity, achievement of hemostasis, overall performance) with a uniform three-point scoring rubric ("poor-unsafe", "adequate-safe", "good-safe"). To test inter-rater reliability, a cross-sectional study of four bariatric surgeons with experience ranging from 4 to 28 years applied the GASS and the global operative assessment of laparoscopic skills (GOALS) to 30 consecutive Roux-en-Y gastric bypass procedure operative videos. Inter-rater reliability was assessed for a simplified dichotomous "safe" versus "unsafe" scoring rubric using Gwet's AC2. RESULTS: The GASS inter-rater reliability was very high across all six domains (0.88-1.00). The GASS performed comparably to the GOALS inter-rater reliability scores (0.96-1.00). The economy of motion and bimanual dexterity items had the highest percentage of unsafe ratings (9.2% and 5.8%, respectively). CONCLUSION: The GASS, a novel six-item instrument of general laparoscopic surgical skills, was designed with a simple scoring rubric (poor-safe, adequate-safe, good-safe) to minimize rater burden and focus feedback to trainees and promotion evaluations on safe surgical performance. Initial evaluation of the GASS is promising, demonstrating high inter-rater reliability. Future research will seek to assess the GASS against a broader spectrum of laparoscopic procedures.

Surgeon experience with insurance barriers to offering gastric bypass as an evidence-based operation for pathologic GERD.

INTRODUCTION: Obesity is an increasingly prevalent public health problem often associated with poorly controlled gastroesophageal reflux disease. Fundoplication has been shown to have limited long-term efficacy in patients with morbid obesity and does not address additional weight-related co-morbidities. Roux-en-Y gastric bypass (RYGB) is the gold standard operation for durable resolution of GERD in patients with obesity, and is also used as a salvage operation for GERD after prior foregut surgery. Surgeons report access to RYGB as surgical treatment for GERD is often limited by RYGB-specific benefit exclusions embedded within insurance policies, but the magnitude and scope of this problem is unknown. METHODS: A 9-item survey evaluating surgeon practice and experience with insurance coverage for RYGB for GERD was developed and piloted by a SAGES Foregut Taskforce working group. This survey was then administered to surgeon members of the SAGES Foregut Taskforce and to surgeons participating in the SAGES Bariatrics and/or Foregut Facebook groups. RESULTS: 187 surgeons completed the survey. 89% reported using the RYGB as an anti-reflux procedure. 44% and 26% used a BMI of 35 kg/m2 and 30 kg/m2 respectively as cutoff for the RYGB. 89% viewed RYGB as the procedure of choice for GERD after bariatric surgery. 69% reported using RYGB to address recurrent reflux secondary to failed fundoplication. 74% of responders experienced trouble with insurance coverage at least half the time RYGB was offered for GERD, and 8% reported they were never able to get approval for RYGB for GERD indications in their patient populations. CONCLUSION: For many patients, GERD and obesity are related diseases that are best addressed with RYGB. However, insurance coverage for RYGB for GERD is often limited by policies which run contrary to evidence-based medicine. Advocacy is critical to improve access to appropriate surgical care for GERD in patients with obesity.

Using video-based assessment (VBA) to document fellow improvement in safely completing the jejunojejunostomy portion of laparoscopic Roux-en-Y gastric bypass (RYGB) surgery.

BACKGROUND: Surgical assessment instruments are used for formative and summative trainee evaluations. To characterize the features of existing instruments and a novel 12-item objective, procedure-specific assessment tool for Roux-en-Y Gastric Bypass (RYGB-OPSA), we evaluated the progress of a single surgical fellow over 17 consecutive surgeries. METHODS: Seventeen consecutive RYGB videos completed between 8/2021 and 1/2022 by an academic hospital surgical fellow were de-identified and assessed by four board-certified bariatric surgeons using Global Operative Assessment of Laparoscopic Skills (GOALS), General Assessment of Surgical Skill (GASS), and RYGB-OPSA which includes the reflection of transverse colon, identification of ligament of Treitz, biliopancreatic and Roux limbs orientation, jejunal division point selection, stapler use, mesentery division, bleeding control, jejunojejunostomy (JJ) anastomotic site selection, apposition of JJ anastomotic site, JJ creation, common enterotomy closure of JJ, and integrity of anastomosis. The GASS measured economy of motion, tissue handling, appreciating operative anatomy, bimanual dexterity, and achievement of hemostasis. RYGB-OPSA and GASS items were scored "poor-unsafe," "acceptable-safe," or "good-safe." Change in performance was measured by linear trendline slope. RESULTS: Over the course of 17 procedures, significant improvement was demonstrated by three GOALS items, GOALS overall score, GASS bimanual dexterity, and three RYGB-OPSA tasks: JJ creation, jejunal division point selection, and stapler use. Achievement of hemostasis declined but never rated "poor-unsafe." Overall RYGB-OPSA and GOALS trendlines documented significant increase across the 17 procedures. CONCLUSION: This examination of a bariatric surgery fellow's operative training experience as measured by three surgical assessment instruments demonstrated anticipated improvements in general skills and safe completion of procedure-specific tasks. Effective surgical assessment instruments have enough sensitivity to show improvement to enable meaningful trainee feedback (low-stakes assessments) as well as the ability to determine safe surgical practice to enable promotion to greater autonomous practice.

The impact of COVID-19 on medium term weight loss and comorbidities in patients undergoing bariatric surgery and its association with psychological wellbeing.

BACKGROUND: The COVID-19 epidemic imposed significant stressors on individuals and changed how medical care is delivered. The affect that this stress has placed on the field of bariatric surgery and the associated outcomes is not well established. METHODS: A retrospective review of a prospectively collected database from a single academic institution was conducted. Weight loss and comorbidity outcomes were compared between a cohort of patients operated on during the pandemic and a matched group operated on prior to COVID-19. GAD-7 and PHQ-9 questionnaires were used to assess for anxiety and depression, respectively. RESULTS: A total of 329 and 155 patients were enrolled in the pre-pandemic and COVID-19 groups respectively. There were no significant differences in pre-operative BMI (p = 0.437) or comorbidities: Type II DM (p = 0.810), hypertension (p = 0.879), sleep apnea (p = 0.502), and hyperlipidemia (p = 0.227). Post-operatively, weight loss was comparable at all time points out to 1 year. Type II DM resolution rates were higher in the control cohort at 6 months (p = 0.007), but not at 12 months (p = 1.000). There was no statistically significant difference in resolution rates between the control group and the COVID-19 group for the other measured comorbidities. There was no difference in objective measures of anxiety and depression when comparing the two groups (both p > 0.05). CONCLUSIONS: The COVID-19 pandemic has fundamentally changed how society and medical systems function. Focusing on pre-operative dietary training and screening for inadequately managed psychological comorbidities yielded similar weight loss outcomes notwithstanding the significant societal and individual stressors with which patients were faced.

Optimizing Bariatric Surgery outcomes: the impact of preoperative elevated hemoglobin A1c levels on composite perioperative outcome measures.

INTRODUCTION: The use of bariatric surgery in the management of obesity and its related morbidity has significantly increased in the US over the past decade. There is a lack of data on the impact of optimal preoperative glycemic control on the morbidity and mortality following bariatric surgery. The aim of this study was to analyze the impact of hemoglobin (Hb) A1c > 7 on outcomes among patients undergoing Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG). METHODS: Data were extracted from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (2017) and limited to patients undergoing an elective laparoscopic RYGB or SG. Multivariable logistic regression was conducted to adjust for other preoperative variables. RESULTS: A total number of 31,060 (69.3%) patients underwent SG, while 13,754 (30.7%) received RYGB. Patients who were older, male, non-Hispanic, smokers, and those with a higher American Society of Anesthesiologist Classification (ASA) score were more likely to have elevated HbA1c levels. Compared to individuals with normal HbA1c levels, patients with elevated levels had no significant difference in mortality (p = 0.902) but did have a difference in composite morbidity and mortality (p < 0.001). On multivariable analysis, elevated HbA1c, older age, increasing body mass index (BMI), elevated creatinine, longer operations, African American race, receiving RYGB, and having a trainee as surgical assistant were found to increase the odds of having an adverse outcome. No significant difference was found within smoking status, sex, ASA Classification, robotic vs laparoscopic, or if a second attending surgeon was assisting. CONCLUSIONS: HbA1c levels and presence of trainees in the OR are modifiable preoperative risk factors for adverse events following bariatric surgery. Improving preoperative glycemic control may be an effective and achievable quality improvement measure.

Sarcopenia is associated with increased mortality but not complications following resection and reconstruction of sarcoma of the extremities.

BACKGROUND AND OBJECTIVES: Evidence regarding the impact of sarcopenia on operative outcomes in patients with sarcoma is lacking. We evaluated the relationship between sarcopenia and postoperative complications or mortality among patients undergoing tumor excision and reconstruction. ​ METHODS: We retrospectively reviewed 145 patients treated with tumor excision and limb reconstruction for sarcoma of the extremities. Sarcopenia was defined as psoas index (PI) < 5.45 cm2 /m2 for men and <3.85 cm2 /m2 for women from preoperative axial CT. Regression analyses were used to assess the association between postoperative complications or mortality with PI, age, gender, race, body mass index, tumor histology, grade, depth, location, size, and neoadjuvant/adjuvant therapy. RESULTS: There were 101 soft tissue tumors and 44 primary bone tumors. Sarcopenia was present in 38 patients (26%). Sarcopenic patients were older (median age: 72 vs 59 years, P = .0010) and had larger tumors (86.5%, >5 cm vs 77.7%, P = .023). Seventy-three patients experienced complications (51%) and 18 patients died within 1 year. Sarcopenia and metastatic disease were associated with increased 12-month mortality (hazard ratio [HR] = 6.68, P < .001; HR: 8.51, P < .001, respectively) but not complications (HR 1.45, P = .155, odds ratio, 1.32, P = .426, respectively). CONCLUSIONS: Sarcopenia and metastatic disease were independently associated with postoperative mortality but no complications following surgery.

Optimizing bariatric surgery outcomes: a novel preoperative protocol in a bariatric population with gastroesophageal reflux disease.

BACKGROUND: The Roux-en-Y gastric bypass (RYGB) isuery ID="Q1" Text="Author:Kindly check the edit made in the article title." -->the most efficacious procedure of choice for obese patients with gastroesophageal reflux disease (GERD). The laparoscopic sleeve gastrectomy (LSG) has high rates of worsening GERD post operatively. Little evidence exists as to whether the use of objective foregut investigations has a meaningful impact on surgical procedure selection. This study examined whether a standard preoperative foregut evaluation protocol effected procedure selection in bariatric patients presenting for surgical evaluation with subjective symptoms of GERD. METHODS: Patients presenting for bariatric surgery evaluation with subjective symptoms of GERD entered into a predetermined protocol of foregut evaluation. Patients initially underwent upper endoscopy and esophagram. If the patient desired a LSG, further testing with esophageal pH testing and high-resolution manometry was ordered. If significant pathology was discovered on any of these investigations RYGB was recommended, if investigations were normal LSG was felt to be permissible. Data were collected prospectively from July 2016 to December 2018 and reviewed. RESULTS: One hundred and thirty-three patients were identified as being eligible to have progressed through the protocol. Pathology was commonly discovered on preoperative evaluations. On EGD Barrett's esophagus was discovered in 4%, grade C or D esophagitis in 18% and hiatal hernia in 36% of patients. On esophagram, hiatal hernia was discovered in 42.3% of patients. Abnormal esophageal motility was discovered in 41% and abnormal DeMeester scores in 83% of tested patients. Of the 133 patients evaluated, the final procedure the patient ultimately underwent was primarily determined based on protocol test results in 24.8% of cases. CONCLUSIONS: Foregut pathology is common in bariatric patients with subjective symptoms of GERD. Implementing a comprehensive protocol to objectively assess these patients leads to a significant clinical impact on which procedure these patients ultimately undergo.

Sarcopenia is a risk factor for complications and an independent predictor of hospital length of stay in trauma patients.

BACKGROUND: Sarcopenia is an independent risk factor for adverse outcomes in critically ill patients. The impact of sarcopenia on morbidity and length of stay in a trauma population has not been completely defined. This project evaluated the influence of sarcopenia on patients admitted to the trauma service. MATERIALS AND METHODS: A retrospective review of 778 patients presenting as a trauma alert at a single institution from 2012-2014 was completed. Records were abstracted for comorbidities and hospital complications. The Hounsfield Unit Area Calculation was collected from admission computed tomography scans. Criteria for sarcopenia were based on the lowest 25th percentile of muscle density measurements. Relationships to patient outcomes were evaluated by univariate and multivariable regression or analyses of variance, when applicable. RESULTS: A total of 432 (55.6%) patients suffered a complication. Sarcopenia was associated with overall complications (P < 0.0001, relative risk 2.54, confidence interval 1.78-3.61) and was an independent risk factor for catheter-associated urinary tract infections (P = 0.011), wound infections (P = 0.011), need for reintubation (P = 0.0062), and length of hospitalization (P = 0.0007). Incorporating sarcopenia into a novel length of stay calculator showed increased prognostic ability for prolonged length of stay over Abbreviated Injury Scale alone (P = 0.0002). CONCLUSIONS: Sarcopenia is an independent risk factor for adverse outcomes and increased length of stay in trauma patients. Prognostic algorithms incorporating sarcopenia better predict hospital length of stay. Identification of patients at risk may allow for targeted interventions early in the patient's hospital course.

The impact of sarcopenia on survival and complications in surgical oncology: A review of the current literature.

Sarcopenia is the subclinical loss of skeletal muscle and strength and has been extensively studied in both the cancer and surgical literature. Specifically, sarcopenia has gained significant recognition as an important prognostic factor for both complications and survival in cancer patients. Herein, we review the current literature to date highlighting the specific impact of sarcopenia in patients undergoing oncologic procedures.

A comparative trial of laparoscopic magnetic sphincter augmentation and Nissen fundoplication.

BACKGROUND: Laparoscopic magnetic sphincter augmentation (MSA) with the LINX device is a promising new therapy for the treatment of gastroesophageal reflux disease (GERD). Initial studies have demonstrated MSA to be safe and effective. However, no direct comparison between MSA and laparoscopic Nissen fundoplication (LNF), the gold standard surgical therapy for GERD, has been performed. METHODS: A single institution, case-control study was conducted of MSA performed from 2012 to 2013 and a cohort of LNF matched for age, gender, and hiatal hernia size. RESULTS: MSA and LNF were both effective treatments for reflux with 75 and 83 % of patients, respectively, reporting resolution of GERD at short-term follow-up. Dysphagia was common following both MSA and LNF, but severe dysphagia requiring endoscopic dilation was more frequent after MSA (50 vs. 0 %, p = 0.01). Need for dilation did not correlate with size of the LINX device or any other examined patient factors. A trend toward decreased adverse GI symptoms of bloating, flatulence, and diarrhea was seen after MSA compared to LNF (0 vs. 33 %). MSA had a shorter operative time (64 vs. 90 min, p < 0.01) but other peri-operative outcomes, including pain, morbidity, and re-admissions were equivalent to LNF. MSA patients were more likely to be self-referred (58 vs. 0 %, p < 0.001). CONCLUSIONS: MSA and LNF are both effective and safe treatments for GERD; however, severe dysphagia requiring endoscopic intervention is more common with MSA. Other adverse GI side effects may be less frequent after MSA. Consideration should be paid to these distinct post-operative symptom profiles when selecting a surgical therapy for reflux disease.

Specialized instrumentation facilitates stable peritoneal access, gastric decompression, and visualization during transgastric endoscopic peritoneoscopy.

PURPOSE: The lack of high-fidelity instrumentation has impeded the development and implementation of natural orifice transluminal endoscopic surgery (NOTES). A steerable flexible trocar (SFT), a rotary access needle (RAN), and an articulating needle knife were developed as components of a flexible instrument set to facilitate transgastric peritoneal access and transluminal abdominal procedures. This cohort study aimed to assess the safety, feasibility, and efficacy of these devices during transgastric peritoneoscopy. METHODS: Ten morbidly obese patients undergoing laparoscopic Roux-en-Y gastric bypass participated in the study. Following laparoscopic access, transgastric peritoneal access was established using the SFT and RAN, and transgastric peritoneoscopy performed. NOTES adhesiolysis was performed in 2 patients with significant intra-abdominal adhesions due to prior surgery. Outcome measures included time to enter the peritoneal cavity, ability to visualize each quadrant of the abdomen, ability to perform adhesiolysis, and complications. RESULTS: Ten patients with a median body mass index as stated in table 1 of 47.5 kg/m(2) were enrolled. Successful transgastric access was achieved in 8 of the 10 patients. One procedure was aborted because of difficulty creating the gastrotomy. Another procedure was aborted because of the difficult passage of the device through the oropharynx. An upper esophageal laceration occurred in one patient. Transgastric peritoneal access required 17.4 ± 5.5 minutes, and peritoneoscopy averaged 24.7 ± 7.6 minutes. The 4 abdominal quadrants were visualized and were accessible with the endoscope in all patients. CONCLUSIONS: The SFT and RAN facilitate transgastric peritoneal access and visualization of difficult-to-reach areas of the peritoneum. These devices provide advanced instrumentation for transgastric NOTES procedures; however, care must be taken during the transoral insertion to avoid complications.

Small molecule SWELL1 complex induction improves glycemic control and nonalcoholic fatty liver disease in murine Type 2 diabetes.

Type 2 diabetes is associated with insulin resistance, impaired pancreatic ß-cell insulin secretion, and nonalcoholic fatty liver disease. Tissue-specific SWELL1 ablation impairs insulin signaling in adipose, skeletal muscle, and endothelium, and impairs ß-cell insulin secretion and glycemic control. Here, we show that ICl,SWELL and SWELL1 protein are reduced in adipose and ß-cells in murine and human diabetes. Combining cryo-electron microscopy, molecular docking, medicinal chemistry, and functional studies, we define a structure activity relationship to rationally-design active derivatives of a SWELL1 channel inhibitor (DCPIB/SN-401), that bind the SWELL1 hexameric complex, restore SWELL1 protein, plasma membrane trafficking, signaling, glycemic control and islet insulin secretion via SWELL1-dependent mechanisms. In vivo, SN-401 restores glycemic control, reduces hepatic steatosis/injury, improves insulin-sensitivity and insulin secretion in murine diabetes. These findings demonstrate that SWELL1 channel modulators improve SWELL1-dependent systemic metabolism in Type 2 diabetes, representing a first-in-class therapeutic approach for diabetes and nonalcoholic fatty liver disease.

A review of 130 humans enrolled in transgastric NOTES protocols at a single institution.

BACKGROUND: The methodology of Natural Orifice Translumenal Endoscopic Surgery (NOTES) has been validated in both human and animal models. Herein is a discussion of our experience gained from the initial 130 patients enrolled in transgastric pre-NOTES and NOTES protocols at our institution. METHODS: A retrospective review of our research database was performed for all patients enrolled in NOTES protocols. The infectious risk of a gastrotomy with and without a NOTES procedure was assessed in 100 patients. Eighty patients completed a true NOTES protocol looking at staging, access, and insufflation with select patients evaluating the potential for bacterial contamination of the abdominal compartment. RESULTS: A total of 130 patients have completed pre-NOTES and NOTES protocols at our institution. We observed no clinically significant contamination of the abdomen secondary to transgastric procedures in 100 patients. Diagnostic transgastric endoscopic peritoneoscopy (DTEP) was completed in 20 patients with pancreatic head masses and found to have a 95% concordance with laparoscopic exploration for assessment of peritoneal metastases. Blind endoscopic gastrotomy and DTEP were evaluated in 40 patients who underwent laparoscopic Roux-en-Y gastric bypass procedures (LSRYGB) and were found to be safe, reliable, and without a clinically significant risk of contamination. Endoscopic peritoneal insufflation was successfully established and correlated with standard laparoscopic insufflation in 20 patients. CONCLUSIONS: Transgastric NOTES is a safe alternative approach to accessing the peritoneal cavity in humans. The risk of bacterial contamination secondary to peroral and transgastric access is clinically insignificant. A device for the facile closure of the gastric defect is the sole factor limiting institution of this methodology as a standalone technique.

Transgastric endoscopic peritoneoscopy does not lead to increased risk of infectious complications.

BACKGROUND: It remains important to determine the risk of bacterial contamination and infectious complications of the peritoneal cavity as it pertains to transgastric natural orifice translumenal endoscopic surgery (NOTES) procedures. The infectious implications of such procedures have been quantified in animal models. This report discusses the infectious risks of transgastric endoscopic peritoneoscopy (TEP) in a human clinical trial. METHODS: Under institutional review board approval, 40 patients scheduled for laparoscopic Roux-en-Y gastric bypass (LRYGB) participated in this study. The TEP procedure was performed without preoperative gastric decontamination and without laparoscopic guidance. Preoperative intravenous antibiotics were given. Saline aspirates were taken from the gastric lumen before endoscopic gastrotomy creation and from the peritoneal cavity after transgastric access. Samples were sent for culture, identification, and bacterial counts. Subgroup analysis was performed on patients taking proton pump inhibitors (PPIs). These data were compared with data for "sterile" peritoneal aspirates from a historical cohort of 50 patients undergoing LRYGB. RESULTS: The median number of bacteria isolated from the gastric aspirates was 980 colony-forming units (CFU)/ml (n=40). The median number of bacteria isolated from the peritoneal aspirates was 323 CFU/ml. Cross-contamination from the stomach to the peritoneal cavity was documented in eight cases. No abscesses or anastomotic leaks were recorded. One port-site infection occurred. Subgroup analysis of 15 patients receiving PPIs showed elevated bacterial counts in gastric aspirates and the post-TEP peritoneal samples compared with patients not receiving PPIs (n=25). This subgroup on PPI's did not have an increase in infectious complications. CONCLUSIONS: Contamination of the peritoneal cavity does occur with TEP, but this does not lead to an increased risk of infectious complications. Similarly, patients receiving PPIs have an increased gastric bacterial load and increased contamination after TEP but not an increased risk of infectious complications.

Novel reconstruction of the extrahepatic biliary tree with a biosynthetic absorbable graft.

OBJECTIVES: The reference standard technique for the reconstruction of the extrahepatic biliary tree is Roux-en-Y hepaticojejunostomy. This procedure is not without complications and may not be feasible in some patients. This project sought to evaluate a novel approach for repairing common bile duct injuries with a biosynthetic graft. This allows for the reconstruction of the anatomy without necessitating an intestinal bypass. METHODS: Study subjects were 11 mongrel hounds. Utilizing an open approach, the common bile duct was transected in each animal. A 1-cm graft of a synthetic bioabsorbable prosthesis was interposed over a 5-Fr pancreatic stent and sewn in place as an interposition tube graft with absorbable sutures. Intraoperative cholangiograms and monthly liver function tests were completed. Animals were killed at 6, 7, 8, 10 and 12 months. RESULTS: The first five animals were killed early in the process of protocol development. One animal developed obstructive symptoms and was killed on postoperative day 14. The next five animals were longterm survivors without evidence of clinically significant graft stenosis. Mean alkaline phosphatase and total bilirubin were normal, at 140 U/l and 0.2 mg/dl, respectively. Histology showed the complete replacement of the graft with native tissue at 6 months. CONCLUSIONS: Biliary reconstruction using a synthetic bioabsorbable prosthetic as an interposition tube graft is feasible based on initial results.

Endoscopic peritoneal access and insufflation: natural orifice transluminal endoscopic surgery.

BACKGROUND: Diagnostic transgastric endoscopic peritoneoscopy is a safe model for exploration of the peritoneum. Endoscopic insufflation of the peritoneal cavity has not been validated in humans. We report here our experience with pneumoperitoneum established endoscopically with a laparoscopic insufflator. DESIGN: Pneumoperitoneum was established with a laparoscopic insufflator through the biopsy channel of the gastroscope. Intra-abdominal pressure was measured with a transfascial Veress needle and compared with endoscopic values. The gastrotomy was used in the creation of the gastric pouch. PATIENTS: Twenty patients undergoing laparoscopic Roux-en-Y gastric bypass participated in the study. Ten had undergone no previous surgery, whereas the other 10 patients had a history of abdominal procedures. INTERVENTIONS: Diagnostic transgastric endoscopic peritoneoscopy was performed through a gastrotomy created endoscopically without laparoscopic visualization. MAIN OUTCOME MEASUREMENTS: Diagnostic findings, operating times, and clinical course were recorded. RESULTS: The average time for transgastric access was 9.6 minutes. This did not vary in patients with previous surgery (P = .3). Endoscopic insufflation was successful in all patients. The mean endoscopic and laparoscopic pressures were 9.80 and 9.75 mm Hg, respectively (P = .9). In no patients were there limitations to visualization of the abdomen. Adhesions were noted in 80% and 10% of patients with and without a history of surgery, respectively (P = .005). There were no complications related to transgastric passage of the endoscope or exploration of the peritoneal cavity. CONCLUSIONS: Although limited by the small sample size in this study, we believe that transgastric access may be considered as an alternative approach to peritoneal insufflation and provides a safe alternative for exploration of the abdomen. Endoscopic insufflation through the biopsy channel by using a laparoscopic insufflator seems to be an effective and safe method for establishing pneumoperitoneum.

Pheochromocytoma does not increase risk in laparoscopic adrenalectomy.

BACKGROUND: Laparoscopic adrenalectomy (LA) has become the standard approach to an adrenal mass. This technique provides for decreased convalescence, less postoperative pain, and improved cosmesis. The use of LA for pheochromocytoma (PHE) has been questioned due to concerns of increased morbidity and negative hemodynamic sequelae. This study aimed to compare the outcomes of LA for PHE with the results of LA for other adrenal pathologies. METHODS: A retrospective chart review was performed for an 11-year period from July 1997 to December 2008. Patient demographics, perioperative data, and outcomes were recorded. Statistical analysis was performed using SPSS 16.0. Statistical significance was defined as a p value less than 0.05. RESULTS: A total of 102 LA procedures were completed for 95 patients. The data for 33 PHE cases were compared with the data for 69 non-PHE cases (26 adenomas, 14 aldosteronomas, 5 cortisol-secreting tumors, 5 multinodular hyperplasias, and 19 other disorders). Five LA procedures were converted to open surgery. Four of these conversions involved patients with PHE (p = 0.03). There was no difference in the mean estimated blood loss (p = 0.2) or operative time (p = 0.1) between the two groups. The frequency of intraoperative hypertension and hypotension did not differ between the PHE and non-PHE cohorts. The complication rate was 7.5% for the PHE group and 6.9% for the non-PHE group (p = 0.7). The patients with PHE had a longer postoperative hospital stay (3.6 vs 2.3 days; p < 0.001) and overall hospital stay (4.9 vs 2.6 days; p < 0.001). Time in the intensive care unit (1.1 vs 0.1 days; p < 0.001) and time until oral intake (1.5 vs 1.0 days; p = 0.02) also were increased in the PHE population. There was one death in the PHE group secondary to congestive heart failure. CONCLUSIONS: Concerns of increased morbidity related to a laparoscopic approach for patients with a diagnosis of PHE are unfounded. In this series, the only disparity in outcomes between the two groups was an increased conversion rate with PHE.

Diagnostic transgastric endoscopic peritoneoscopy: extension of the initial human trial for staging of pancreatic head masses.

BACKGROUND: The validity of natural orifice transluminal endoscopic surgery (NOTES) was confirmed in a human trial of 10 patients undergoing diagnostic transgastric endoscopic peritoneoscopy (DTEP) for staging of pancreatic head masses. This report is an update with 10 additional patients in the series and includes bacterial contamination data. METHODS: The patients in this human trial were scheduled to undergo diagnostic laparoscopy for abdominal staging of a pancreatic head mass. A second surgeon, blinded to the laparoscopic findings, performed a transgastric endoscopic peritoneoscopy (TEP). The findings of laparoscopic exploration were compared with that those of the TEP. Diagnostic findings, operative times, and clinical course were recorded. Bacterial contamination data were collected for the second cohort of 10 patients. Bacterial samples were collected from the scope before use and the abdominal cavity before and after creation of the gastrotomy. Samples were assessed for bacterial counts and species identification. Definitive care was rendered based on the findings from laparoscopy. RESULTS: In this study, 20 patients underwent diagnostic laparoscopy followed by DTEP. The average time for completion of diagnostic laparoscopy was 10 min compared with 21 min for TEP. The experience acquired during the initial 10 procedures translated to a 7-min decrease in TEP time for the second 10 cases. For 19 of the 20 patients, DTEP corroborated laparoscopic findings for surgical decision making. One endoscopic and five laparoscopic biopsies were performed. Pancreaticoduodenectomy was performed for 14 patients and palliative gastrojejunostomy for 6 patients. No cross-contamination of the peritoneum or infectious complications were noted. No significant complications related to either the endoscopic or laparoscopic approach occurred. CONCLUSIONS: This study supports the authors' previous conclusions that the transgastric approach to diagnostic peritoneoscopy is feasible, safe, and accurate. The lack of documented bacterial contamination further supports the use of this technique. Technical issues, including intraabdominal manipulation and gastric closure, require further investigation.