Volumetric Pouch Study After Laparoscopic Sleeve Gastrectomy

Not Applicable

Completed

• Conditions: Bariatric Surgery Candidate; Obesity, Morbid
• Interventions: Procedure: sleeve gastrectomy

• Registration Number: NCT04880902
• Lead Sponsor: Kafrelsheikh University

Brief Summary

This study aimed to evaluate Laparoscopic Sleeve Gastrectomy in the treatment of morbidly obese patients pre and post-operatively after 3 months, 6 months, and 1-year follow-up and assess the volumetric changes of the gastric reservoir 1 year after LSG using multi-slice computer tomography.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-01
• Primary Completion: 2020-10-01
• Study Completion: 2020-11-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-10
• Last Update Submitted: 2021-05-10
• Study First Posted: 2021-05-11
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• BMI of > 40 kg/m 2 or > 35 kg/m2 with comorbidities e.g. hypertension and type 2 DM.
• All patients failed in supervised conservative management for obesity for at least 2 years.

Exclusion Criteria

• BMI > 60
• previous bariatric surgery
• symptomatic reflux oesophagitis disease, gastric pathology (tumor, active peptic ulcer)
• Significant psychological disorder, active alcohol or substance abuse
• severe eating disorders (bulimia)
• severe systemic disease making anesthesia or surgery prohibitively risky (American Society of Anesthesiologists (ASA) class IV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sleeve gastrectomy followed by volumetric assessment	sleeve gastrectomy	-

Primary Outcome Measures

Name	Time	Method
Gastric volume after surgery	1 month	gastric reservoir volume after performance of laparoscopic sleeve gastrectomy

Trial Locations

Locations (1)

Kafrelsheikh university; 🇪🇬 Kafr Ash Shaykh, Egypt