Patients with psychiatric comorbidity can safely undergo bariatric surgery with equivalent success.

INTRODUCTION: Patients with psychiatric disorder were reported to have a poor outcome in bariatric surgery. Few studies have examined the outcome of laparoscopic sleeve gastrectomy (LSG) and laparoscopic adjustable gastric banding (LAGB) in patients with psychiatric history. We aimed to compare excess weight loss (%EWL) in patients with and without psychiatric comorbidities who underwent LSG or LAGB. METHODS: Patients undergoing LSG or LAGB were identified from our prospective database. A multidisciplinary team evaluated all patients preoperatively, including a psychological evaluation. Patients with the diagnosis of depression, anxiety, bipolar disorder, and schizophrenia were included in the psychiatric comorbidity group (PSY). Others were included in group NON-PSY. All patients were first screened to be psychologically stable to undergo surgery. Initial BMI and %EWL at 3, 6, and 12 months postoperatively were compared. RESULTS: A total of 590 patients (81.4 % women), with a median BMI of 43.8 kg/m(2) (range 30-99) who underwent LSG (n = 222) or LAGB (n = 368) from January 2006 to June 2013, were identified. Psychiatric comorbidities that were well controlled at the time of surgery were found in 188 patients (31.9%). Diagnostic criteria for depression were met in 154 patients (26.1%), 75 patients suffered from anxiety (12.7%), 9 from bipolar disorder, and 4 from schizophrenia (0.7%). Initial BMI was not different between the two groups. No significant difference in %EWL between the groups was found during follow-up (44.13 vs. 43.37%EWL, respectively, at 1 year; p = 0.76). When LSG and LAGB patients were analyzed as subsets, again no difference in %EWL at 1 year was found for PSY vs. NON-PSY (LSG: 51.56 vs. 54.86%EWL; LAGB: 38.48 vs. 38.45%EWL, all p = ns). In multivariate analysis, the differences from unadjusted analysis persisted. CONCLUSION: These findings demonstrate that a similar %EWL can be achieved in patients undergoing LSG or LAGB despite the presence of well-controlled psychiatric comorbidity.

Improvement in severe pulmonary hypertension in obese patients after laparoscopic gastric bypass or sleeve gastrectomy.

BACKGROUND: Case reports have suggested that bariatric surgery improves pulmonary hypertension. We performed a retrospective, case-control study to evaluate the safety and efficacy of bariatric surgery in obese patients with severe pulmonary hypertension. METHODS: Morbidly obese patients followed in a specialty pulmonary hypertension clinic who underwent laparoscopic gastric bypass or sleeve gastrectomy between 2008 and 2013 (n = 10) were compared to a BMI-matched cohort managed with maximal medical therapy (n = 10). Patients with advanced malignancy, prior heart/lung transplantation, and pulmonary hypertension from thromboembolism were excluded. Primary outcomes assessed were changes in use of pulmonary vasodilatory and diuretic medications, need for home oxygen therapy, and mean pulmonary arterial pressures. Secondary outcomes measured were excess body weight loss, perioperative mortality and morbidity, and hospital length of stay. RESULTS: More patients who underwent bariatric surgery experienced improvements in pulmonary arterial pressures (75 vs. 0%, p = 0.02), reduction in or discontinuation of pulmonary vasodilatory therapy (67 vs. 0%, p = 0.01), and decreased diuretic requirements (86 vs. 13%, p = 0.01) than the control cohort. Seventy-five percent of patients previously on home oxygen discontinued therapy after surgery, while oxygen requirements increased in 50% of the control cohort. Excess body weight loss was greater in the surgical group (EWL 68 vs. 19%, p < 0.001). Seven significant complications in five patients occurred in the first postoperative year, but there were no mortalities. Mean inpatient length of stay was 5 days. CONCLUSIONS: Laparoscopic gastric bypass and sleeve gastrectomy in obese patients improves pulmonary hypertension in the short term.

Fibrin sealant for mesh fixation in laparoscopic groin hernia repair does not increase long-term recurrence.

BACKGROUND: Methods of groin hernia repair include laparoscopic techniques using tissue-penetrating mesh fixation or non-penetrating fixation. Concerns regarding hernia repair include postoperative chronic pain, sexual dysfunction, and recurrence. Earlier estimations of recurrence rates have largely been based on nationwide databases, where reoperation rates have been used as a surrogate measure for recurrence, which may underestimate the true recurrence rates. The aim of this study was to evaluate long-term recurrence in patients who had undergone transabdominal pre-peritoneal (TAPP) laparoscopic groin hernia repair using either fibrin sealant or tacks for mesh fixation. METHODS: This study used data from the Danish Hernia Database to create the following cohort: All patients operated laparoscopically for primary groin hernia with a TAPP procedure using fibrin sealant for mesh fixation. These patients were matched 1:2 with patients, where the mesh was fixated using tacks. A validated questionnaire was sent to all included patients to determine recurrence, which was defined as reoperation or clinical diagnosis of recurrence by a physician. Follow-up was from index operation to either reoperation date, date of clinical recurrence diagnosis, or response date. RESULTS: A total of 2273 persons (n = 2340 groins) were included, of which 1535 returned the questionnaire, resulting in a response rate of 66.2% with a median follow-up time of 31 months (range 0-62). Among these, 114 (7.4%) recurrences were found, of which 30 (5.8%) were in the fibrin sealant group and 84 (8.3%) in the tacks group (p = 0.084). The Cox regression analysis found no difference in recurrence with the use of tacks compared to fibrin sealant (hazard ratio 0.8) [95% CI (0.5-1.2)]. CONCLUSION: We found no significant difference in long-term reoperation rates and clinical recurrences in patients undergoing TAPP repair with meshes fixated with fibrin sealant compared with tacks.

Comprehensive complication index for NOTES procedures: results from a randomized controlled trial and comparison to published NOTES complication data.

OBJECTIVE: This investigation uses the comprehensive complication index (CCI) to compare complications after natural orifice transluminal endoscopic surgery (NOTES) procedures. BACKGROUND: NOTES procedures are developed to miniaturize surgical trauma. NOTES publications inconsistently report complications. The CCI improves reporting of complications. METHODS: The CCI is calculated using complication data from a single center, double blind, randomized controlled trial comparing transvaginal [transvaginal cholecystectomy (TVC), N = 41] and conventional laparoscopic cholecystectomy (CLC, N = 51). Complications are assessed using the classification of surgical complications (CSC). Two different scenarios are applied to the CSC for definition of complications with an emphasis on minor complications. CSC data are fed into the free online CCI-calculator. The CCIs from complication data from other NOTES reports are calculated accordingly and compared to our results. RESULTS: The CCI allows easy indexing of complications with or without a CSC table. For scenario I, the mean CCI of CLC versus TVC is 3.3 (± 6.3; SD) versus 3.5 (± 6.4; n.s.) and for scenario II it is 7.6 (± 6.4) versus 6.5 (± 7.0; n.s.). The difference of the mean between the two scenarios is highly significant (p < 0.000). The mean CCIs of both groups and scenarios are below the CCI of 8.7 for a grade I CSC complication. Similar calculation of CCIs from other NOTES publications yields mean CCIs below 8.7 for the surgical procedures reported. CONCLUSION: The CCI results in a single, easily comparable complication index for surgical procedures whereas the CSC yields tabular results. A significant difference in interpretation occurs with variation in definition of complications. Average CCIs below a value of 10 describe low complication rates. Authors need to describe their definition of complications if using the CSC and the CCI. More emphasis should be given to reporting of minor complications. The use of the CCI for NOTES procedures will enable international comparison.

Truncal vagotomy without drainage: Are there long-term concerns?

INTRODUCTION: Panelists at SAGES 2013 suggested that inadvertent vagotomy was the cause of the bloating, diarrhea, and delayed gastric emptying that is sometimes seen after complex foregut reconstructions that require extensive esophageal dissection. Is it correct to ascribe these symptoms to vagotomy and imply that a drainage procedure should always accompany truncal vagotomy? To examine the long-term sequelae of truncal vagotomy alone, the present report examines clinical outcomes of 49 patients who had truncal vagotomy without drainage at the time of placement of an adjustable gastric band. METHODS: Forty-nine patients underwent truncal vagotomy with laparoscopic adjustable gastric banding in an Investigational Review Board approved clinical trial to determine whether the addition of a vagotomy would increase weight loss when compared to gastric banding alone. The details of this trial were presented at SAGES in 2010 [1]. The patients in this study have been followed for over 5 years. RESULTS: Forty-nine patients have been followed for a mean of 5.6 years. All except one have experienced a loss of hunger and cessation of gastric borborygmus. One patient showed mild delayed gastric emptying when evaluated for GERD. None of the patients experienced intractable diarrhea. CONCLUSIONS: These outcomes do not support the prevailing surgical recommendation and dogma that vagotomy should always be accompanied by a drainage procedure. Furthermore, these outcomes would suggest that it is misleading to ascribe inadvertent vagotomy as the cause of the bloating, diarrhea, and delayed gastric emptying that may occasionally be reported by patients after difficult esophageal dissections.

Follow-up after laparoscopic inguinal hernia repair, can it be done by phone? A prospective study in 300 patients, the PINQ-PHONE.

BACKGROUND: The most important long-term complications after inguinal hernia repair are chronic pain and recurrence. Previous follow-up studies showed that physical examination is the only reliable method of follow-up to detect recurrences. However, physical examination is laborious and time consuming. We designed a telephone questionnaire as a method of follow-up after laparoscopic inguinal hernia surgery; the PINQ-PHONE (Post-INguinal-repair-Questionnaire by telePHONE). The aim of this study is to validate the PINQ-PHONE for detecting both asymptomatic and symptomatic recurrences. METHODS: This prospective study contained 300 randomly selected patients after laparoscopic inguinal hernia repair. All patients were contacted by telephone and the PINQ-PHONE was carried out. The PINQ-PHONE contains four elements; three questions and a do-it-yourself Valsalva maneuvre. Subsequently, all patients were seen in clinic and physical examination (gold standard) was done. RESULTS: The majority (96 %) was male and the mean age was 66 (range 26-93) years old. The mean interval between surgery and study inclusion was 58 (range 6-141) months. In five (1.7 %) patients, a recurrence was found. All of them replied positively to one or more elements of the PINQ-PHONE. Two-hundred-fifty-two (84 %) patients replied negatively to all elements and none of them had a recurrence. The overall sensitivity was 1.00 and the overall specificity was 0.86. CONCLUSION: This study validated the PINQ-PHONE. It is a reliable, practical, and simple method of follow-up after laparoscopic inguinal hernia repair to detect both symptomatic and asymptomatic recurrences.

Randomized trial on the physiologic impact of NOTES.

BACKGROUND: Our previous work revealed significantly less acidosis in swine undergoing natural orifice translumenal endoscopic surgery (NOTES) using endoscopic air insufflation than swine undergoing standard laparoscopy. We wanted to evaluate the differential effects of CO2 versus intra-abdominal pressure as source for this finding. In addition, we investigated the endocrine stress response between swine undergoing NOTES peritoneoscopy with CO2 insufflation and animals undergoing standard diagnostic laparoscopy with CO2. MATERIALS AND METHODS: Twenty-eight (28) female 50-kg domestic pigs were randomly assigned to one of four groups using a permuted block randomization table: Group 1: NOTES using CO2 insufflation, Group 2: NOTES using air insufflation, Group 3: laparoscopy max pressure 12 mmHg and Group 4: laparoscopy with max pressure 7 mmHg. Invasive monitoring lines were placed. Pneumoperitoneum was established by the respective method and maintained for 90 min, visualizing liver, spleen and colon. Arterial blood gas was obtained at baseline and four additional time points. Serum TNF-α for POD (postoperative day) 1 and cumulative urine adrenaline for the procedure were determined by ELISA. ANOVA and t test were used for statistical comparison. The study was Institutional Animal Care and Use Committees approved. RESULTS: All experiments were completed as outlined. Blood pH showed a significant difference between groups. Serum TNF-α revealed higher levels for NOTES CO2 on POD 1 than standard laparoscopy (p = 0.03). CONCLUSION: NOTES animals with CO2 insufflation initially experienced similar pH compared to standard laparoscopy but recovered to levels seen in low-pressure laparoscopy and NOTES with air. NOTES with CO2 appears to elicit a stronger stress response in this study than standard or low-pressure laparoscopy or NOTES with air.

Clinical risk factors for anastomotic leakage after laparoscopic anterior resection for rectal cancer: a systematic review and meta-analysis.

BACKGROUND: Anastomotic leakage (AL) is a serious complication in laparoscopic rectal cancer surgery, and risk factors for AL are not well defined. Herein, we conducted a systematic review to quantify the clinicopathologic factors predictive for AL in patients who underwent laparoscopic anterior resection (LAR) for rectal cancer. METHODS: A systematic search of electronic databases (PubMed, Embase, Cochrane CENTRAL, Scopus Database, and Wanfang Database) for studies published until August 2014 was performed. Cohort, case-control studies, and randomized controlled trials that examined clinical risk factors for AL were included. RESULTS: Fourteen studies (seven prospective and seven retrospective studies) involving 4580 patients met final inclusion criteria. From the pooled analyses, five demographic factors were found to be significantly associated with the development of AL, including male gender (OR 2.04, 95% CI 1.50-2.77), BMI ≥25 kg/m(2) (OR 1.46, 95% CI 1.00-2.14), ASA score >2 (OR 1.74, 95% CI 1.04-2.93, P = 0.04), tumor size >5 cm (OR 1.63, 95% CI 1.01-2.64, P = 0.05), and preoperative chemotherapy (OR 1.67, 95% CI 1.10-2.55, P = 0.02). Four operative factors were significantly associated with increased risk of AL, including longer operative time (95% CI 1.71-5.77, P = 0.0002), number of stapler firings ≥3 (OR 0.17, 95% CI 0.07-0.41, P < 0.001), intra-operative transfusions/blood loss >100 mL (OR 3.79, 95% CI 2.48-5.49, P < 0.001), and anastomosis level within 5 cm from the anal verge (OR 9.63, 95% CI 3.05-30.43, P = 0.0001), while pelvic drain (OR 0.43, 95% CI 0.19-0.94, P = 0.04) was significantly associated with a lower AL rate. CONCLUSION: Our analysis identified several clinicopathologic factors associated with AL in patients who underwent LAR. The knowledge of these risk factors may influence treatment- and procedure-related decisions and possibly reduce the leakage rate.

One-year human experience with a novel endoluminal, endoscopic gastric bypass sleeve for morbid obesity.

INTRODUCTION: Here, we report the first series of patients with 1-year implantation of a novel, endoluminal, endoscopically delivered and retrieved gastro-duodeno-jejunal bypass sleeve (GJBS) (ValenTx, Inc. Carpinteria, CA, USA). In this report, we present the safety, feasibility of the device, weight loss, and changes in comorbidities. METHODS AND PROCEDURES: A prospective, single-center, 12-month trial was designed. The patients are morbidly obese individuals who meet the NIH criteria for bariatric surgery. The GJBS is a 120-cm sleeve secured at the esophago-gastric junction with endoscopic and laparoscopic techniques that is designed to create an endoluminal gastro-duodeno-jejunal bypass. The device was implanted and, at the completion of the trial, retrieved with an endoscopic technique. The primary endpoints were safety and incidence of adverse events. The secondary outcomes included the percentage of excess weight loss (EWL) and changes in comorbidities, specifically glucose control, use of antihyperglycemics, and changes in hemoglobin A1C levels. RESULTS: From July 2009 until October 2009, 13 patients were prospectively enrolled for the 1-year trial. The study included five men and eight women with a mean preoperative BMI of 42 kg/m(2). One patient was excluded, at the time of endoscopic evaluation, due to inflammation at the GE junction. Two additional patients required early explantation of the device, within the first 4 weeks, due to patient intolerance. Upon explant of the device, both patients' symptoms improved. In the remaining ten patients, the device was implanted, left in situ for 12 months, and then retrieved endoscopically. Safe delivery of the cuff at the gastro-esophageal junction was seen in all ten patients whom had device implants, without complication. No esophageal leak was seen immediately post-procedure or during follow-up. The sleeve device was well tolerated within the bowel lumen during the 12-month study, specifically, no bowel erosions, ulceration, or pancreatitis was observed. All ten patients reached the 1-year mark. Of the ten, six had fully attached and functional devices throughout the follow-up, verified by endoscopy. The mean percentage EWL, at 1 year, in this group was 54 %. In the remaining four patients, partial cuff detachment was observed at follow-up endoscopy. The percentage EWL was lower in this group. Of the six patients that reached a year with a fully attached device, five were followed at an average of 14-months post-explant (26 months from the time of device implant). These five maintained an average percentage EWL of 30 % at the 14-month post-explant follow-up. Co-morbidites measured included diabetes mellitus, hypertension, hyperlipidemia, and use of antihyperglycemics. Each of the measured comorbidities showed improvement during the 12-month trial. DISCUSSION: The endoluminal, GJBS can be safely placed and retrieved. The short-term data show it is well tolerated with a good safety profile. It achieves excellent weight loss results with over 70 % of all comorbidities resolved or significantly improved.

Trans-oral anterior fundoplication: 5-year follow-up of pilot study.

BACKGROUND: This is a report of an IRB-approved pilot study of 13 patients who received a trans-oral anterior partial fundoplication for the treatment of GERD using an ultrasound-guided, flexible surgical stapler. All patients had a history of PPI use, objective evidence of GERD, and no significant comorbidity. Under general anesthesia, a flexible stapler was passed trans-orally into the stomach and placed two or three quintuplets of titanium staples approximately 3 cm above the gastroesophageal junction. The stapler contains an ultrasonic range finder, video camera, and illuminator. METHODS: Primary follow-up at 6 weeks included pH metrics, GERD-HRQL scores, and PPI use. The protocol allowed annual telephone interviews for the following 5 years to collect GERD-HRQL scores, PPI use, satisfaction with the procedure, and willingness to have the procedure again. RESULTS: At 6 weeks, mean total acid exposure was significantly reduced, and 12/13 patients reduced GERD-HRQL scores by ≥50%. Twelve of 13 patients had stopped daily GERD medications, and nine of 13 had stopped all GERD medications. Each year, 11 of the 13 patients could be reached with all 13 patients having at least 4-year follow-up. Throughout the follow-up period, GERD-HRQL scores were normal (<10) in all but one patient. All patients would agree to do the procedure again. The median satisfaction score is 8 (range 6-10) on a scale of 1-10. None reported dysphagia. At 1 year, 54% of respondents (6/11) had eliminated PPI use, with another 27% (3/11) taking a reduced dose. Combining respondents at 4 and 5 years to account for all patients, 54% (7/13) had eliminated and another 23% (3/13) reduced PPI use ≥50 %. CONCLUSION: At 5 years, the procedure remained effective as demonstrated by the improved quality of life and changes in PPI use. The results remained stable after the second year.

Recurrence of biliary disease following non-operative management in elderly patients.

INTRODUCTION: The purpose of this study was to determine the proportion of symptomatic recurrence following initial non-operative management of gallstone disease in the elderly and to test possible predictors. METHODS: This is a single institution retrospective chart review of patients 65 years and older with an initial hospital visit (V1) for symptomatic gallstone disease, over a 4-year period. Patients with initial "non-operative" management were defined as those without surgery at V1 and without elective surgery at visit 2 (V2). Baseline characteristics included age, sex, Charlson comorbidity index (CCI), diagnosis, and interventions (ERCP or cholecystostomy) at V1. Outcomes assessed over 1 year were as follows: recurrence (any ER/admission visit following V1), surgery, complications, and mortality. A survival analysis using a Cox proportional hazards model was performed to assess predictors of recurrence. RESULTS: There were 195 patients initially treated non-operatively at V1. Mean age was 78.3 ± 7.8 years, 45.6% were male, and the mean CCI was 2.1 ± 1.9. At V1, 54.4% had a diagnosis of biliary colic or cholecystitis, while 45.6% had a diagnosis of cholangitis, pancreatitis, or choledocholithiasis. 39.5% underwent ERCP or cholecystostomy. Excluding 10 patients who died at V1, 31.3% of patients had a recurrence over the study period. Among these, 43.5% had emergency surgery, 34.8% had complications, and 4.3% died. Median time to first recurrence was 2 months (range 6 days-4.8 months). Intervention at V1 was associated with a lower probability of recurrence (HR 0.3, CI [0.14-0.65]). CONCLUSION: One-third of elderly patients will develop a recurrence following non-operative management of symptomatic biliary disease. These recurrences are associated with significant rates of emergency surgery and morbidity. Percutaneous or endoscopic therapies may decrease the risk of recurrence.

Laparoscopic ventral/incisional hernia repair: updated Consensus Development Conference based guidelines

BACKGROUND: The Executive board of the Italian Society for Endoscopic Surgery (SICE) promoted an update of the first evidence-based Italian Consensus Conference Guidelines 2010 because a large amount of literature has been published in the last 4 years about the topics examined and new relevant issues. METHODS: The scientific committee selected the topics to be addressed: indications to surgical treatment including special conditions (obesity, cirrhosis, diastasis recti abdominis, acute presentation); safety and outcome of intraperitoneal meshes (synthetic and biologic); fixing devices (absorbable/non-absorbable); abdominal border and parastomal hernia; intraoperative and perioperative complications; and recurrent ventral/incisional hernia. All the recommendations are the result of a careful and complete literature review examined with autonomous judgment by the entire panel. The process was supervised by experts in methodology and epidemiology from the most qualified Italian institution. Two external reviewers were designed by the EAES and EHS to guarantee the most objective, transparent, and reliable work. The Oxford hierarchy (OCEBM Levels of Evidence Working Group*. "The Oxford 2011 Levels of Evidence") was used by the panel to grade clinical outcomes according to levels of evidence. The recommendations were based on the grading system suggested by the GRADE working group. RESULTS AND CONCLUSIONS: The availability of recent level 1 evidence (a meta-analysis of 10 RCTs) allowed to recommend that not only laparoscopic repair is an acceptable alternative to the open repair, but also it is advantageous in terms of shorter hospital stay and wound infection rate. This conclusion appears to be extremely relevant in a clinical setting. Indications about specific conditions could also be issued: laparoscopy is recommended for the treatment of recurrent ventral hernias and obese patients, while it is a potential option for compensated cirrhotic and childbearing-age female patients. Many relevant and controversial topics were thoroughly examined by this consensus conference for the first time. Among them are the issue of safety of the intraperitoneal mesh placement, traditionally considered a major drawback of the laparoscopic technique, the role for the biologic meshes, and various aspects of the laparoscopic approach for particular locations of the defect such as the abdominal border or parastomal hernias.(AU)