Staple Line Reinforcement Using SEAMGUARD® versus Suture Over Sewing During Laparoscopic Sleeve Gastrectomy for Super Morbidly Obese Patients: A Prospective Randomized Clinical Trial.

Itroduction: Although theoretically a simple procedure, laparoscopic sleeve gastrectomy (LSG) can be followed by life-threatening complications. Early postoperative complications include staple line bleeding and leakage. Staple line reinforcement (SLR) has been used to decrease these complications. There are various methods for reinforcement of staple line such as suture over sewing, placing omental flap, using buttressing material, and spraying fibrin glue along the staple line. However, it is controversial whether SLR reduces the rate of staple line complications or not. MATERIALS AND METHODS: A prospective randomized clinical trial included 200 super morbidly obese patients randomized into two groups: Group 1 with reinforcement of the staple line by SEAMGUARD® (Gore Medical, Newark, Delaware) and Group 2 with reinforcement of the staple line using suture over sewing. RESULTS: The mean operative time was significantly shorter in Group 1 than Group 2 (62.6 ± 14.5 vs. 84.7 ±15.8 min, p=0.02). Intraoperative blood loss was significantly lower in Group 1 than Group 2 (17.1± 19.1 vs. 56.8 ± 27.9ml, p=0.00). Staple line hematomas were significantly higher in Group 2. There was no difference in postoperative bleeding between the two groups. No leak was reported in both groups. The cost was higher in Group 1. CONCLUSION: Reinforcing the staple line in laparoscopic sleeve gastrectomy using suturing is equal to SEAMGUARD® in all aspects except shorter operative time and lower intraoperative blood loss with SEAMGUARD®.

Sleeve Gastrectomy and Cholecystectomy are Safe in Obese Patients with Asymptomatic Cholelithiasis. A Multicenter Randomized Trial.

BACKGROUND: Obesity is a severe health problem. Gallstones may symptomatize after sleeve gastrectomy (SG). Concomitant laparoscopic cholecystectomy (LC) with SG is controversial. The effects of SG and LC versus delayed LC following SG in obese patients with asymptomatic gallbladder stones were evaluated. METHODS: A randomized trial of 222 morbidly obese patients with gallbladder stones divided them into two equal groups: SG + LC and SG-only. This multicenter study conducted from January 2016 to January 2019. RESULTS: Except for operative time and postoperative hospital stay, there was no statistically significant difference between LSG + LC group and SG group (P < 0.001). In SG + LC group, LC added 40.7 min to SG, three patients (3%) required conversion, early postoperative complications occurred in 9 cases (9/111, 9%), three cases required re-intervention (3%). In SG group, the complicated cases required LC were 61 cases (61/111, 55%). Acute cholecystitis (26/61, 42.7%) was the most common gallstone symptoms. Most complicated cases occurred in the first-year follow-up (52/61, 85%). In the delayed LC group (61 patients), operative time was 50.13 ± 1.99 min, open conversion occurred in 2 cases (2/61, 3.2%), early postoperative complications occurred in four patients (4/61, 6.4%) and postoperative re-intervention were due to bile leaks and cystic artery bleeding (2/61, 3.2%). CONCLUSIONS: SG with LC prolongs the operative time and hospital stay, but the perioperative complications are the same as delayed LC; LC with SG minimizes the need for a second surgery. Concomitant LC with SG is safe.

Role of ursodeoxycholic acid in the prevention of gallstone formation after laparoscopic sleeve gastrectomy.

PURPOSE: Postoperative cholelithiasis (CL) is a latent complication of bariatric surgery. The aim of this study was to evaluate the role of ursodeoxycholic acid (UDCA) in the prevention of CL after laparoscopic sleeve gastrectomy (LSG). METHODS: This was a retrospective analysis of the prospectively collected data of patients with morbid obesity who underwent LSG. Patients were subdivided into two groups: Group I, which did not receive prophylactic treatment with UCDA after LSG; and Group II, which received UCDA therapy for 6 months after LSG. Patients' characteristics, operation duration, weight loss data, and incidence of CL at 6 and 12 months postoperatively were collected. RESULTS: A total of 406 patients (124 males, 282 females) with a mean age of 32.1 ± 9.4 years were included. The mean baseline body mass index (BMI) was 50.1 ± 8.3 kg/m2. Group I comprised 159 patients, and Group II comprised 247 patients. The two groups showed comparable demographics, % excess weight loss (EWL), and decrease in BMI at 6 and 12 months after LSG. Eight patients (5%) developed CL in Group I, whereas no patients in Group II did (P = 0.0005). Preoperative dyslipidemia and rapid loss of excess weight within the first 3 months after LSG were the risk factors that significantly predicted CL postoperatively. CONCLUSION: The use of UCDA effectively reduced the incidence of CL after LSG in patients with morbid obesity. Dyslipidemia and rapid EWL in the first 3 months after LSG significantly predisposed patients to postoperative CL.

Evaluation of Safety and Feasibility of Using LigaSure During Clipless Single-Incision Laparoscopic Cholecystectomy: A Prospective Clinical Study.

Background: Single-incision laparoscopic cholecystectomy (SILC) is a minimally invasive procedure designed to minimize the number and size of the incisions needed for cholecystectomy. Titanium clips are traditionally used to close the cystic duct and artery. Although it is considered safe, dislodgement can result in bleeding and biliary leakage. Using LigaSure for duct sealing is still controversial. The aim of this study was to evaluate the safety and feasibility of using LigaSure to close the cystic duct during SILC. Methods: A prospective study over two years was conducted at the General Surgery Department, Mansoura University Hospital, on 102 patients, 51 in each group. They underwent SILC using LigaSure (Group 1) or titanium clips (Group 2) to control the cystic duct and artery. Results: The data analyzed included demographic data, operative time, intra- and postoperative complications, postoperative pain, and hospital stay. The operative time was significantly shorter in LigaSure group (68.5 ± 9.8 versus 72.9 ± 10.6 minutes in the clips group, P .03). There was no significant difference between the two groups regarding postoperative bile leak or bleeding. However, two cases in Group 1 and four cases in Group 2 were converted to multiple port laparoscopic cholecystectomy; this was statistically nonsignificant. Postoperative pain and hospital stay showed no significant difference between the two groups. Two patients in each group developed port-site incisional hernia. Conclusions: Clipless SILC using LigaSure is a feasible and safe procedure with acceptable morbidity with shorter operative time than SILC using clips. Nevertheless, the risk of port-site incisional hernia should be explained to the patients.

30-day morbidity and mortality of revisional bariatric surgery - An international multi-centre collaborative (BROAD) study.

INTRODUCTION: Revisional bariatric surgery (RBS) for insufficient weight loss/weight regain or metabolic relapse is increasing worldwide. There is currently no large multinational, prospective data on 30-day morbidity and mortality of RBS. In this study, we aimed to evaluate the 30-day morbidity and mortality of RBS at participating centres. METHODS: An international steering group was formed to oversee the study. The steering group members invited bariatric surgeons worldwide to participate in this study. Ethical approval was obtained at the lead centre. Data were collected prospectively on all consecutive RBS patients operated between 15th May 2021 to 31st December 2021. Revisions for complications were excluded. RESULTS: A total of 65 global centres submitted data on 750 patients. Sleeve gastrectomy (n = 369, 49.2 %) was the most common primary surgery for which revision was performed. Revisional procedures performed included Roux-en-Y gastric bypass (RYGB) in 41.1 % (n = 308) patients, One anastomosis gastric bypass (OAGB) in 19.3 % (n = 145), Sleeve Gastrectomy (SG) in 16.7 % (n = 125) and other procedures in 22.9 % (n = 172) patients. Indications for revision included weight regain in 615(81.8 %) patients, inadequate weight loss in 127(16.9 %), inadequate diabetes control in 47(6.3 %) and diabetes relapse in 27(3.6 %). 30-day complications were seen in 80(10.7 %) patients. Forty-nine (6.5 %) complications were Clavien Dindo grade 3 or higher. Two patients (0.3 %) died within 30 days of RBS. CONCLUSION: RBS for insufficient weight loss/weight regain or metabolic relapse is associated with 10.7 % morbidity and 0.3 % mortality. Sleeve gastrectomy is the most common primary procedure to undergo revisional bariatric surgery, while Roux-en-Y gastric bypass is the most commonly performed revision.

Outcome and Adverse Events of Endoscopic Bariatric Stents for Management of Leakage after Bariatric Surgery.

INTRODUCTION: Bariatric leakage (BL) is a serious complication with a variety in available treatment options. Endoscopic stenting is preferred because of its minimally invasive nature in morbidly obese patients. Various modifications have been applied to stents since its use in palliation of malignant strictures. Few studies have exclusively evaluated the efficacy of bariatric stents in management BL. METHODS: A retrospective cohort study of patients with BL managed by bariatric stents in the period between July 2014 and January 2019. The primary outcome was the clinical success in healing of leakage and secondary outcomes included adverse events (AEs), hospital stay and procedure-related mortality. RESULTS: Forty-five patients were included in this study. Clinical success occurred in 33 patients (73.3%). There was no stent-related mortality. The most frequent stent-related complications were reflux (62.2%), intolerance (55.6%), and migration (17.8%). Severe AEs occurred in 9 patients (20%). The overall complications rate was higher in diabetic patients (P = 0.048). Intolerance was significantly associated with shorter interval to management (P = 0.02). Stent migration was higher in male patients (P = 0.019) and higher BMI (P = 0.024). CONCLUSION: Endoscopic stenting is a double-edged weapon that must be handled cautiously. It is a highly effective therapy, and early intervention is the main determinant of its efficacy. But it is not a treatment without complications (80%). The variant and high prevalence of complications mandates a strict follow-up throughout the stenting duration.

Kidney injury molecule-1: A potential marker of renal recovery after laparoscopic sleeve gastrectomy.

BACKGROUND: Bariatric surgeries were reported to improve diabetes and hypertension; however, the effect on renal recovery has not been fully explored. The aim of this study was to evaluate the effect of laparoscopic sleeve gastrectomy (LSG) in morbidly obese patients on renal function, degree of albuminuria, and kidney injury molecule-1 (KIM-1) level. METHODS: This was a prospective observational study conducted at Mansoura University Hospitals from January to June 2017. Forty-four morbidly obese patients (29 females and 15 males) who met the 1991 WHO criteria for obesity surgery were included. Patients underwent surgical LSG for treatment of morbid obesity, and all were followed for 6 months after surgery. Demographic, clinical, and laboratory data were collected and compared before and after surgery. Primary endpoints were the differences of albuminuria, estimated glomerular filtration rate (eGFR) and serum KIM-1 between baseline (pre-surgery) and 6-month post-surgery values. RESULTS: Six-month post-surgery data showed significant reduction of body mass index, HbA1c, microalbuminuria, and serum KIM-1, and a significant increase in eGFR (all, P < 0.001). The serum KIM-1 level positively correlated with microalbuminuria and serum creatinine (r = 0.596, P = 0.001 and r = 0.402, P = 0.034, respectively). Postoperative data showed that patients with microalbuminuria had significantly lower eGFR and higher KIM-1 values than those without microalbuminuria (P = 0.003 and 0.049, respectively). CONCLUSION: We showed potential benefits of LSG against obesity-associated kidney damage. This is evidenced by improving eGFR and reducing levels of both KIM-1 and microalbuminuria. The serum level of KIM-1 may be a potential marker for renal recovery after LSG.

Gastric Stenosis After Sleeve Gastrectomy: an Algorithm for Management.

BACKGROUND: Gastric stenosis (GS) is a well-recognized complication after sleeve gastrectomy (SG) with a negative impact on patients' nutritional status and quality of life. There is no consensus on a validated, comprehensive management algorithm for GS. This study evaluates treatment modalities and proposes a management algorithm for obstructive gastric symptoms (OGSs) after SG. METHODS: This is a retrospective cohort study of patients with GS after SG between January 2013 and January 2019. Patients with concomitant GS and staple-line leak were excluded. The primary outcome was the clinical response to treatment. RESULTS: Forty-nine patients presented with OGSs. One patient underwent urgent surgical treatment for acute migration of cardia. Of 42 patients who had evident GS, pneumatic balloon dilatation (PBD) achieved clinical success in 28 (66.7%) patients. Six patients were diagnosed with indolent GS, and four of them improved after empirical PBD. The mean interval from index surgery to PBD was 5.3 (± 4.2) months. Longer duration of PBD session was associated with better clinical outcomes (5.8 ± 3.7 vs. 3.2 ± 1.7 min) (P = 0.017). After failed PBD, endoscopic stenting (n = 2) and revisional surgery (n = 7) were performed with clinical success in all patients. CONCLUSION: PBD using achalasia balloon is the mainstay of treatment with good clinical outcomes. The utility of endoscopic stenting for GS should be different from its use for leakage in aspects of dwelling time and required endoscopic expertise. RYGB is the gold standard revisional procedure due to the high success rate and technical familiarity. Controversial aspects of management require future prospective comparative studies.

Protein Energy Malnutrition After One-Anastomosis Gastric Bypass with a Biliopancreatic Limb ≤200 cm: A Case Series.

Background: Increased popularity of one-anastomosis gastric bypass (OAGB) is associated with increased reports on the procedure-related complications. Protein-energy malnutrition (PEM) is a serious complication that may mandate reversal. The primary outcome of this study is the outcome of surgical management of PEM after OAGB. Methods: A retrospective cohort study of patients presented with PEM after OAGB between January 2014 and December 2018. Patients with a biliopancreatic limb (BPL) >200 cm were excluded. PEM was diagnosed based on the Global Leadership Initiative on Malnutrition criteria. Indications for reversal of OAGB due to PEM included failure of conservative measures, intolerable symptoms, and hepatic decompensation. Results: Eight patients presented with PEM and were reversed to normal anatomy or Roux-en-Y gastric bypass. The incidence of postoperative 30-day complications in this series was 37.5% (n: 3/7). Postoperative mortality due to hepatic cell failure occurred in 1 patient. Two patients deceased before reversal, one secondary to severe soft tissue infection, whereas the cause of death could not be confirmed for the second. Conclusion: Socioeconomic status and thorough preoperative counselling are important to predict patient commitment to postoperative supplementations and laboratory investigations. Bariatric teams should apply innovative methods as telemedicine to make patient compliance easier. The etiology of PEM cannot be purely explained by the BPL length. Revisional surgery is mandatory for resistant, recurrent, or complicated PEM.

Potential combination topical therapy of anal fissure: development, evaluation, and clinical study†.

To treat anal fissure, internal anal sphincterotomy may be associated with surgical risks and incidence of incontinence. Botulinum toxin injection into the anal sphincter is invasive and expensive. Headache and hypotension hindered topical treatment with glyceryl trinitrate. Greater patient compliance, potentiated efficacy, reduced side effects, and lower cost are the major advantages offered by the combination therapy. Therefore, combination topical gels of nifedipine (NIF), lidocaine hydrochloride (LDH) and betamethasone valerate (BMV) were prepared and evaluated regarding viscosity, pH, drug content, and in vitro release. Compatibility study of drug-drug and drug-excipient mixtures preceded the formulation. Stability study was performed. A prospective randomized clinical trial was conducted for six weeks to assess the efficacy of the optimized formula in the treatment of anal fissure either acute (AAF, 37 patients) or chronic (CAF, 34 patients) in comparison with three single drug market products. The compatibility was indicated except in case of LDH with each of poloxamer 407 (P407), methylparaben, and propylparaben as well as BMV with P407. The gels showed acceptable viscosity ranges, tolerated pH values, and drugs content limits complying with the pharmacopeial limit. The gel containing 10% Transcutol® (F2) was selected as optimized formula due to the significant (p < 0.05) enhancement in NIF release. The recommended storage temperature was 8 °C. In comparison with the market products, the optimized gel can be represented as a potential combination therapy of acute and chronic anal fissures as suggested by significantly increased healing% and significantly reduced pain, bleeding, anal discharge and itching without side effects.

Portomesenteric venous thrombosis: an early postoperative complication after laparoscopic biliopancreatic diversion.

The number of bariatric operations, as well as the incidence of perioperative complications, has risen sharply in the past ten years. Perioperative acute portal vein thrombosis is an infrequent and potentially severe postoperative complication that has not yet been reported after biliopancreatic diversion (BPD). Three cases are presented of portal vein thrombosis that occurred following BPD treatment for morbid obesity and type 2 diabetes. The thromboses were detected by abdominal ultrasound and computed tomography with intravenous contrast. The portomesenteric venous thromboses in all three cases presented as unexpected abdominal pain several days after discharge from the hospital. The complications occurred despite adequate perioperative prophylaxis and progressed to bowel gangrene in the diabetic patients only. These cases demonstrate the occurrence of this rare type of complication, which may be observed by physicians that do not routinely treat bariatric patients. Awareness of this surgical complication will allow for early diagnosis and prompt initiation of adequate therapy.