Tamer Youssef1, Emad Abdalla2, Khalid El-Alfy2, Ibrahim Dawoud2, Mosaad Morshed2, Mohamed Farid2. 1. General and Endocrine Surgery, Mansoura Faculty of Medicine, Mansoura University, Gomhoria St., Mansoura, Egypt. tamyousif@yahoo.com. 2. General Surgery, Mansoura Faculty of Medicine, Mansoura University, Mansoura, Egypt.
Abstract
BACKGROUND: The most frequent and most feared complication after laparoscopic sleeve gastrectomy (LSG) is gastric leak (GL). We hypothesize that botulinum neurotoxin (botulinum type A (BTX-A)) injection into the pyloric sphincter muscle at the time of operation may decrease the risk of postoperative GL. METHODS:Consecutive patients with morbid obesity (MO) treated by LSG were enrolled. Patients were randomly allocated into two groups: group I (intrapyloric BTX-A injection was performed) and group II (no injection was performed). The primary outcome measure was number of patients developing GL. Secondary outcome measures were percent of excess weight loss, postoperative complications, and their management. RESULTS:One hundred and fifteen patients (86 (74.8 %) females) were randomized into two groups of 57 patients (group I) and 58 patients (group II). Four patients in group II developed GL versus no patient in group I (P = 0.04). Ten patients in group I and two in group II developed refractory epigastric pain (P = 0.01). Other complication rates were comparable for both groups. Mean preoperative BMI of patients in both groups had significantly decreased from 54.64 ± 6.82 to 42.99 ± 5.3 at 6 months and to 39.09 ± 5.14 at 12 months (P < 0.001). CONCLUSIONS:LSG is an effective, safe, and minimally invasive procedure for treatment of MO. No patient in whom pyloric BTX-A injection was performed developed postoperative GL versus four patients in whom injection was not performed. The difference in GL rate was statistically significant, thus favoring the use of pyloric BTX-A injection during LSG.
RCT Entities:
BACKGROUND: The most frequent and most feared complication after laparoscopic sleeve gastrectomy (LSG) is gastric leak (GL). We hypothesize that botulinum neurotoxin (botulinum type A (BTX-A)) injection into the pyloric sphincter muscle at the time of operation may decrease the risk of postoperative GL. METHODS: Consecutive patients with morbid obesity (MO) treated by LSG were enrolled. Patients were randomly allocated into two groups: group I (intrapyloric BTX-A injection was performed) and group II (no injection was performed). The primary outcome measure was number of patients developing GL. Secondary outcome measures were percent of excess weight loss, postoperative complications, and their management. RESULTS: One hundred and fifteen patients (86 (74.8 %) females) were randomized into two groups of 57 patients (group I) and 58 patients (group II). Four patients in group II developed GL versus no patient in group I (P = 0.04). Ten patients in group I and two in group II developed refractory epigastric pain (P = 0.01). Other complication rates were comparable for both groups. Mean preoperative BMI of patients in both groups had significantly decreased from 54.64 ± 6.82 to 42.99 ± 5.3 at 6 months and to 39.09 ± 5.14 at 12 months (P < 0.001). CONCLUSIONS: LSG is an effective, safe, and minimally invasive procedure for treatment of MO. No patient in whom pyloric BTX-A injection was performed developed postoperative GL versus four patients in whom injection was not performed. The difference in GL rate was statistically significant, thus favoring the use of pyloric BTX-A injection during LSG.
Authors: Raquel Sánchez-Santos; Carlos Masdevall; Aniceto Baltasar; Candido Martínez-Blázquez; Amador García Ruiz de Gordejuela; Enric Ponsi; Andres Sánchez-Pernaute; Gregorio Vesperinas; Daniel Del Castillo; Ernest Bombuy; Carlos Durán-Escribano; Luis Ortega; Juan Carlos Ruiz de Adana; Javier Baltar; Ignacio Maruri; Emilio García-Blázquez; Antonio Torres Journal: Obes Surg Date: 2009-07-02 Impact factor: 4.129