An interventional study of laparoscopic sleeve gastrectomy in Morbid Obesity, sponsored by Mansoura University. Completed. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2014-12-24.
Sponsored by Mansoura University · Not applicable, Interventional, and Treatment
Leakage is the most common complication after laparoscopic sleeve gastrectomy which may amount to 20% in some studies. We hypothesize that Clostridium botulinum neurotoxin A (BTX-A) injection into the pyloric sphincter during the operation may decrease the risk of postoperative gastric leakage.
Laparoscopic sleeve gastrectomy (LSG) provides similar weight loss and resolution of obesity comorbidities to that of duodenal switch and Roux-en-Y gastric bypass. Inspite of its encouraging results, the pretended feasibility of the operative procedure can be associated with a remarkable operative morbidity. The main reason is gastric leakage from stable line which occurs in about 0-20% of the cases. The main accepted cause of leakage is formation of a high gastric tube pressure. Injection of BTX-A into the pyloric sphincter intraoperative will cause temporal paralysis of pyloric sphincter muscles postoperatively; so the pressure inside the gastric pouch will be decreased abolishing the formation of high pressure tube with subsequent leakage.
922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.
This study's enrollment of 130 is above the median of 60 across 590 interventional studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Body mass index >40 or >35 with hypertension or DM
Exclusion Criteria:
Previous bariatric surgery
patients undergoing laparoscopic sleeve gastrectomy without BTX-A injection into the pyloric sphincter
Procedure: laparoscopic sleeve gastrectomy
patients undergoing laparoscopic sleeve gastrectomy with BTX-A injection into the pyloric sphincter
Procedure: laparoscopic sleeve gastrectomy
creation of a gastric tube of 100cc using a stapler.
number pf patients developing postoperative gastric leakage
Time frame: 0ne year
percent of patients with excess weight loss
Time frame: one year
No study locations are listed for this record.
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Mansoura University