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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.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.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).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.

Background/Aims: Peroral endoscopic myotomy (POEM) is a novel procedure for the treatment of achalasia and spastic esophageal disorders. Experience with POEM is limited, but its reported outcomes are excellent. It is deemed safe even for patients with prior interventions. Methods: This retrospective review included patients who underwent POEM at a tertiary US center. POEM was performed in a multidisciplinary approach by advanced endoscopists and foregut surgeons. Clinical success was defined as a post-POEM Eckardt score ≤3. Results: A total of 125 patients were included. Median follow-up period was 18 months (interquartile range, 10-22 months). Clinical success was achieved in 92% of patients and persisted at 12 months in 88% of patients. Mucosal barrier failure (MBF) occurred in 7 patients, 2 of whom required surgical intervention. MBF was more common in patients with prior laparoscopic Heller myotomy (19% vs. 3%, p=0.015). MBF requiring surgical intervention occurred early in the learning curve. Conclusions: POEM is safe and effective in the treatment of achalasia and spastic esophageal disorders even after failed prior interventions. Clin Endosc 2020;53:321-327

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 cmThere 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).Sarcopenia and metastatic disease were independently associated with postoperative mortality but no complications following surgery.

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. 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. 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. 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.

Summary Peroral endoscopic myotomy (POEM) in patients with achalasia who are status post bariatric surgery may be technically challenging due to postsurgical scarring and altered anatomy. The aim of the study was to assess the efficacy and safety of POEM for achalasia in patients with prior bariatric surgery. A review of prospectively maintained databases at three tertiary referral centers from January 2015 to January 2021 was performed. The primary outcome of interest was clinical success, defined as a post-treatment Eckardt score ≤ 3 or improvement in Eckardt score by ≥ 1 when the baseline score was

Type 2 diabetes (T2D) is associated with insulin resistance, impaired insulin secretion from the pancreatic β-cell, and nonalcoholic fatty liver disease (NAFLD). SWELL1 (LRRC8a) ablation impairs adipose and skeletal muscle insulin-pAKT2 signaling, β-cell insulin secretion and glycemic control - suggesting that SWELL1-LRRC8 complex dysfunction contributes to T2D pathogenesis. Here, we show that ICl,SWELLand SWELL1 protein are reduced in adipose and β-cells in murine and human T2D. Combining cryo-electron microscopy, molecular docking, medicinal chemistry, and functional studies, we define a structure activity relationship to rationally-designed active derivatives (SN-40X) of a SWELL1 channel inhibitor (DCPIB/SN-401), that bind the SWELL1-LRRC8 hexameric complex, restore SWELL1-LRRC8 protein, plasma membrane trafficking, signaling and islet insulin secretion via SWELL1-dependent mechanisms.In vivo, SN-401 and active SN-40X compounds restore glycemic control and prevents NAFLD by improving insulin-sensitivity and insulin secretion in murine T2D. These findings demonstrate that small molecule SWELL1 modulators restore SWELL1-dependent insulin-sensitivity and insulin secretion in T2D and may represent a first-in-class therapeutic approach for T2D and NAFLD.

Background Sarcopenia is associated with an increased risk of operative morbidity and mortality. The impact of sarcopenia in inflammatory bowel disease (IBD) has not been evaluated. This study assessed the role of sarcopenia on operative outcomes in IBD. Methods A retrospective review of American College of Surgeons National Surgical Quality Improvement Program data of patients with IBD was completed. Records were abstracted for comorbidities and perioperative complications. The Hounsfield unit average calculation was used from preoperative computed tomography (CT). Criteria for sarcopenia were based on the lowest 25th percentile. Complications were graded using the Clavien-Dindo classification system. Statistical analysis was completed using SAS. Results There were 178 patients included. Sarcopenic patients were more likely to be older (P = 0.001), have hypertension (odds ratio = 2.23), and be diabetic (5.27). In those patients younger than 40 years, sarcopenia was an independent predictor of complications. This subset was significantly more likely to have a normal or elevated body mass index. Conclusions In this population, the average age of sarcopenic patients is increased from those who do not meet criteria. Among patients younger than 40 years, sarcopenia affects surgical outcomes. Assessment of sarcopenia can be used to improve preoperative management and describe risks before surgery in patients with IBD.

Gastroesophageal reflux disease (GERD) affects two thirds of the American population. Obesity is also a disease that affects two thirds of the population. The pathophysiology of reflux disease is reasonably understood, however, the degree to which obesity affects this disease remains poorly defined. Therefore the approach to GERD in the obese patient requires special attention and its own algorithm. A literature search was conducted to consolidate the current available literature on GERD and its management in the obese. In addition, the authors reviewed the literature and present expert opinion on controversial topics. It is well established that GERD is increased in obesity and the pathophysiology is reviewed. Management options for GERD are discussed, with a focus on the obese population. Management strategies including fundoplication and gastric bypass are discussed. In addition, bariatric surgery in the setting of GERD is also reviewed. Currently this is an extremely controversial topic and this white paper presents a strong review of the literature to help guide the management of this challenging disease in this population. Expert recommendations are given throughout the paper based upon the current available data.

The laparoscopic sleeve gastrectomy (LSG) is now the most commonly performed bariatric surgery in the world. Multiple studies have demonstrated the equivalence between the LSG and Roux-en-Y gastric bypass (RYGB) with regard to weight loss and comorbidity resolution. Few studies have examined the differences in body mass composition change between the two procedures. Sixty-three patients undergoing either LSG or RYGB underwent calculation of total body mass, ideal body mass, lean mass, and fat mass by air displacement plethysmography (BodPodtm) prior to surgery and at 12 months postoperatively. Calculations of excess body weight, % excess weight loss, change in % fat mass, and change in % lean mass were then performed at each time interval. Thirty-three patients underwent LSG and 30 patients underwent RYGB. Mean percent excess weight loss in the LSG and RYGB group was 47.2% and 53.4% respectively (p = 0.165, 95% CI − 14.8–2.6). Mean percent change in fat mass for the LSG group and RYGB group was 9.2% and 10.51% respectively (p = 0.249, 95% CI − 0.86–3.2). Mean percent change in lean mass for the LSG group and RYGB group was 9.4% and 10.49% respectively (p = 0.383, 95% CI 2.85–1.13). The LSG and RYGB both impart dramatic meaningful loss in excess body weight. In addition, both the LSG and RYGB impart dramatic reductions in fat mass. However, both procedures induce loss of lean mass and there appears to be no difference between the two procedures in this regard despite their anatomic and physiologic differences.

As technology continues to improve, endoscopic procedures have become more sophisticated and precise. This chapter reviews the indications, technique, and post-procedural management of several advanced tissue resection methods: radiofrequency ablation (RFA), endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), and endoscopic full thickness resection (EFTR). Specific step-by-step details of each technique are explained, and details regarding the management of complications is also described.

Obesity is public health problem of epidemic proportions. Esophageal dysmotility including achalasia is more commonly seen in an obese population. Standard therapy for achalasia can be complicated by hepatomegaly and a post-surgical anatomy in a pre- and post-bariatric population. Peroral endoscopic myotomy (POEM) has not been adequately studied in this population. A retrospective review of a prospectively collected database was completed. Patients who had undergone a Roux-en-y gastric bypass (RYGB) prior to or following a POEM were enrolled. Patient demographics, operative information and post-operative course data was collected. Six patients underwent POEM prior to or after RYGB. There were no peri-operative complications with an average length of stay of 1.2 days. Five patients experienced a clinical success with excellent symptom resolution. The one failure was in the setting of type III achalasia, but did have objective evidence of lower esophageal sphincter (LES) relaxation post-operatively. POEM in the setting of bariatric surgery is safe and feasible. The potential increase in GERD following POEM is obviated by RYGB anatomy. In an obese individual, a staged POEM prior to or following a RYGB is an appropriate treatment algorithm for obese and achalasia.

When partial gastrectomy is performed, there are several options available for reconstruction including Billroth I (BI), Billroth II (BII), and Roux-en-Y (REY). While utilized less frequently than the others, the BII is indicated in specific circumstances such as the multiply operated abdomen, anticipated need for biliary tree access, and avoidance of complications specifically associated with the alternative operations. Postoperatively, morbidities associated with this procedure include nutritional deficiencies, dumping syndromes, afferent loop syndrome, delayed gastric emptying, bile reflux, and ulcers. Familiarity with the BII is critical for the management of patients who have undergone this procedure in the past as well as keeping it in the armamentarium of surgical options should it become necessary intraoperatively.

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.

Intravenous (i.v.) acetaminophen has the potential to reduce postoperative narcotic analgesic requirement but this has not been reported in bariatric surgery. As lower dosages could reduce undesirable narcotic side effects, we investigated the opioid-sparing effect of concomitant i.v. acetaminophen in bariatric surgery.We performed a retrospective review of our electronic medical records of laparoscopic Roux-en-Y gastric bypasses (LRYGB) performed for severe obesity between 2011 and 2013. We identified 183 patients that received scheduled i.v. acetaminophen in addition to morphine sulfate (MSO4) patient-controlled analgesia (PCA). A cohort of 229 patients from the preceding 2 years who were treated with MSO4 PCA but not acetaminophen was used as a historical control. Patient demographic characteristics and narcotic use data were extracted from electronic medical records. Student's t test or linear regression was used as appropriate (P.05).During the first 24-hour postoperative period after LRYGB, narcotic analgesic demand (total PCA demand including nondelivery of narcotic due to lock-out) was reduced by 25% with the concomitant use of i.v. acetaminophen (40.5 versus 30.9 average pushes; P.05). During the same period, narcotic analgesic dosage requirement was cut down by 20% in the study group (average of 29.9 versus 24.1 mg of MSO4; P.05). Linear regression analysis confirmed that these changes were independent of age, gender, and body mass index distribution, or type 2 diabetes mellitus.Scheduled i.v. acetaminophen reduces the demand for and the requirement of narcotic analgesia after LRYGB. We provide new evidence in support of the routine use of multimodal analgesia that includes scheduled i.v. acetaminophen in the initial 24-hour period after bariatric surgery.

Background Bariatric surgery provides for a reliable and sustainable solution to the obesity epidemic. The gold standard bariatric surgical procedure is the Roux-en-Y gastric bypass (RYGB). Assessment of this population preoperatively and work-up of postoperative complications often includes radiographic evaluation. Repeated exposure to radiation is not without complication. Objective Assess the association between the RYGB and exposure to ionizing radiation. Setting Academic medical center. Methods Patients were identified by their ICD-9 code as having had a RYGB at the Massachusetts General Hospital (MGH) from 2002 to 2012. The number of abdominal and pelvis (A/P) computed tomography (CT) scans performed was determined and converted into an effective dose (ED) and expressed as milliSeiverts (mSv) to illustrate the biologic effects of radiation. Results From 2002 to 2012, 1789 primary laparoscopic RYGBs were completed. Fifty-five revisional operations were completed on 51 patients. Of these, 38 had both their index and second operation at the MGH. A total of 1065 A/P CTs were completed in the laparoscopic RYGB population (mean = .6), and 106 A/P CTs were done in the revisional surgery cohort (mean = 2.8). The mean ED of radiation was 56.1 mSv and 19.5 mSv for the index and revisional populations, respectively. Conclusions This study demonstrated the significant cumulative radiation exposure attributable to A/P CTs. This exposes the patient to a potential increased risk of malignancy as well as imposing a financial burden on the healthcare system. The findings of this study raise the awareness of an increased risk of radiation exposure for this population and the necessity of creation of a dedicated algorithm for the mindful utilization of CT imaging.

Gastroesophageal reflux disease (GERD) is a common condition in western societies with as many 40% experiencing symptoms monthly [1]. It can affect one’s health related quality of life and is associated with a number of complications including an increased risk for esophageal adenocarcinoma [2]. The Nissen fundoplication has been the most widely used procedure for the surgical management of GERD and hiatal hernias for six decades. It was first described by Rudolf Nissen in 1956 for the treatment of GERD [3] and then later in 1961 for hiatal hernias [4]. With the advent of laparoscopic surgery it is primarily performed via a minimally invasive approach as it reduces the morbidity associated with an open procedure [5]. The long-term efficacy of anti-reflux surgery had been validated in numerous studies [6–10]. A prospective, randomized control trial with 10-year follow-up definitively establishes the safety and efficacy of both laparoscopic partial and Nissen fundoplications [9, 10]. After 10 years, a minority of patients had return of reflux symptoms, and when surveyed, nearly all were satisfied with their outcome and decision to have undergone the surgery [9, 10].

Gastroesophageal reflux disease (GERD) is an increasingly prevalent disease in today’s society. While many are adequately treated with medications, a not insignificant proportion will be dissatisfied with their symptom control on maximal medical treatment or will have side effects precluding them from taking acid-reducing medications. In this population, objective testing to substantiate the diagnosis of GERD including 24-h pH testing, EGD, and upper gastrointestinal (UGI) series is imperative to confirming the diagnosis. Symptoms that are best treated by anti-reflux surgery include heartburn and regurgitation, particularly in those that have a positive response to medical management. In the setting of magnetic sphincter augmentation device (MSAD) placement, high-resolution esophageal manometry is preferred to verify adequate strength and coordination of esophageal contractions. The MSAD is an alternative to the classic Nissen fundoplication. In some, it may be preferable due to the decreased incidence of side effects such as bloating and inability to belch or vomit. This chapter describes indications, essential steps, variations, and complications of this procedure using the Linx system. It provides a detailed template operative note for the procedure.

Gastroesophageal reflux disease (GERD) is an increasingly prevalent disease in today’s society. While many are adequately treated with acid-suppressing medications, a proportion of this population will be dissatisfied with their symptom control or will have side effects precluding them from taking acid-reducing medications. In this population, objective testing to substantiate the diagnosis of GERD including 24-h pH testing, EGD, and upper gastrointestinal (UGI) series is imperative to confirm the diagnosis. High-resolution esophageal manometry may also be indicated in those with dysphagia to help risk stratify chances for postoperative dysphagia and/or identify primary motility disorders of the esophagus. While there is no consensus in the literature, most would agree that the surgeon should at least consider a partial fundoplication in those patients with dysphagia and ineffective esophageal motility based on high-resolution esophageal manometry. This chapter describes indications, essential steps, variations, and complications of this procedure. It provides a detailed template operative note for the procedure.

Resection of Meckel’s diverticulum is performed for complications resultant of the diverticulum or incidental finding during laparotomy. This chapter lists the indications, essential steps, common technical variations, and complications of the procedure. A detailed template operative dictation note is included.

Minimally invasive surgery (MIS) has transformed operative practices by offering patients procedures with reduced hospital stay and recovery compared to that of open operations. In spite of the advantages of a MIS approach, the application to pancreatectomy has only recently emerged. This review aims to analyze and discuss available comparative studies as they relate to resection techniques for treatment of malignant disease. A PubMed search was used to obtain original studies and meta-analyses relating to MIS pancreatectomy from 2008 to 2013. Several studies were identified that reported on the application of MIS specifically to the treatment of cancer, many of which were retrospective, single-institution studies. Notwithstanding an inherent selection bias, several studies suggest that MIS can provide equivalent R0 resection rates, number of lymph nodes harvested, and survival to that of open resection. Furthermore, parameters such as blood loss and length of stay are significantly reduced in patients treated with MIS. The current literature supports the conclusion that MIS is safe and effective as a treatment for cancer in well-selected patients in the hands of experienced surgeons. However, the published studies to date are observational in nature and therefore higher quality studies will be needed to support the application and generalizability of MIS in the treatment of pancreatic malignancies.

Gastroesophageal reflux disease (GERD) is common, and the outcomes of primary laparoscopic antireflux surgery are excellent. A minority of individuals will present with recurrent symptoms, typically of GERD or dysphagia, and seek revisional surgery. Herein is a discussion of the most common presentations and etiologies of failed antireflux surgery. In addition, the preoperative assessment and diagnostic tests utilized in the workup of this population are reviewed. Finally, the operative approach and outcomes related to performing revision laparoscopic antireflux surgery are examined including the use of Roux-en-Y gastric bypass in this patient population.

Achalasia is a rare motility disorder of the esophagus presenting with classic symptoms of dysphagia, regurgitation, chest pain and weight loss. Once diagnosed the treatment of achalasia can be pharmacological, endoscopic or surgical and each may be an appropriate choice based on the patient’s presentation and comorbidities. While good success can be achieved with pneumatic dilation and peroral endoscopic myotomy is showing exciting promise, the laparoscopic Heller myotomy with partial fundoplication remains the gold standard surgical intervention in the treatment of achalasia with excellent functional outcomes and safety profile.

Cachexia is a debilitating condition characterized by extreme skeletal muscle wasting that contributes significantly to morbidity and mortality. Efforts to elucidate the underlying mechanisms of muscle loss have predominantly focused on events intrinsic to the myofiber. In contrast, less regard has been given to potential contributory factors outside the fiber within the muscle microenvironment. In tumor-bearing mice and patients with pancreatic cancer, we found that cachexia was associated with a type of muscle damage resulting in activation of both satellite and nonsatellite muscle progenitor cells. These muscle progenitors committed to a myogenic program, but were inhibited from completing differentiation by an event linked with persistent expression of the self-renewing factor Pax7. Overexpression of Pax7 was sufficient to induce atrophy in normal muscle, while under tumor conditions, the reduction of Pax7 or exogenous addition of its downstream target, MyoD, reversed wasting by restoring cell differentiation and fusion with injured fibers. Furthermore, Pax7 was induced by serum factors from cachectic mice and patients, in an NF-κB–dependent manner, both in vitro and in vivo. Together, these results suggest that Pax7 responds to NF-κB by impairing the regenerative capacity of myogenic cells in the muscle microenvironment to drive muscle wasting in cancer.

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.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.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).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.

Obesity-induced hypertension is associated with vascular endothelial dysfunction. Recently, our laboratory has demonstrated a critical role of the mammalian target of rapamycin complex 1 (mTORC1) signaling pathway in cardiovascular regulation. Here, we tested the hypothesis that dysregulation of mTORC1 signaling is involved in the endothelial dysfunction associated with obesity in mice and humans. We found that diet-induced obese (DIO) mice that display vascular endothelial dysfunction as compared to lean controls have increased mTORC1 signaling in aortic lysates indicated by the elevated (p2 ; n=4; age 51±6 yrs; BMI 54±3 kg/m 2 ) humans exhibited a strong trend towards increased phosphorylated S6 protein compared to normal-weight (BMI 2 ; n=3; age 44±15 yrs; BMI 26±1 kg/m 2 ) individuals (5.0±1.9 vs 0.8±0.4AU; p=0.12), suggesting increased vascular mTORC1 signaling in human obesity. Next, we used an adenoviral construct of a constitutively active (CA) S6-kinase (Ad-CAS6K) to enhance mTORC1 signaling. In mouse endothelial cells, Ad-CAS6K increased mRNA expression of oxidative stress (NOX1and NOX2) and inflammatory markers (IL-1β) and decreased endothelial NOS expression (p

The introduction of antiseptic techniques by Lister and the description of the first laparoscopic cholecystectomy by Muhe are illustrations of innovative approaches proposed in an effort to improve surgical outcomes and decrease morbidity. The introduction of natural orifice transluminal endoscopic surgery (NOTES) by Kalloo and Kantsevoy ushered in a new era in minimally invasive surgery. In this technique, numerous ports and standard laparoscopic instruments are eschewed in an effort to improve cosmesis, morbidity, and time for convalescence. Given the unique characteristics of a natural orifice approach and the viable minimally invasive alternatives, it is critical that a transparent evaluation of the approach be undertaken. Herein is a discussion of the necessary elements of the ethical evaluation of NOTES.

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/m2 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.

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. Biliary reconstruction using a synthetic bioabsorbable prosthetic is possible

Background Diagnostic transgastric endoscopic peritoneoscopy has been used to evaluate the abdomen. We present our experience with transgastric endoscopic peritoneoscopy (TEP) to access the peritoneum, direct trocar placement, and perform adhesiolysis without laparoscopic visualization in patients undergoing laparoscopic Roux-en-Y gastric bypass. Methods Forty patients participated. There are 2 arms to the study. The initial 20 patients underwent pre-insufflation of the abdomen prior to TEP. The second 20 had no pre-insufflation. Ten patients in each arm had no surgical history. The other 10 had previous intra-abdominal procedures. TEP was performed through a gastrotomy created without laparoscopic visualization. Adhesions were visualized and taken down endoscopically prior to trocar placement. Diagnostic findings, operative times, and clinical course were recorded. Results Average TEP time was 19 min. Three patients had limited visualization due to intra-abdominal adhesions (2) and omental fat (1). Three of the 20 without and 17 of 20 with a history of intra-abdominal surgery had adhesions visualized endoscopically. Endoscopic adhesiolysis was performed in 1 and 4 patients in these groups respectively. Six occult umbilical hernias, 1 inguinal hernia, and 1 hiatal hernia were noted on endoscopic exploration. There were no complications related to intubation of the stomach, accessing the peritoneum, or endoscopic exploration. Conclusion TEP is a safe and accurate means to access the peritoneum, visualize the abdominal wall, perform adhesiolysis, and direct trocar placement without laparoscopic guidance. Safe and reliable gastric closure remains the sole limitation to its clinical use outside of a protocol necessitating a gastrotomy.

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.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.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.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.

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.