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NCT04880902 Clinical Trial

Volumetric Pouch Study After Laparoscopic Sleeve Gastrectomy

Bariatric Surgery Candidate Clinical Trial

Official title:
Volumetric Pouch Study After Laparoscopic Sleeve Gastrectomy: Effect of the Pouch Size on Excessive Weight Loss and Weight Regain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04880902
Other study ID # 01006786978123
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2018
Est. completion date November 1, 2020

Study information
Verified date May 2021
Source Kafrelsheikh University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date November 1, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• sleeve gastrectomy
Laparoscopic sleeve gastrectomy had evident therapeutic effects on preexisting obesity-related comorbidities. All patients were referred for abdominal MSCT with a volumetric assessment of gastric pouch within 1 month of surgery and 1 year postoperatively

Locations
Country Name City State
Egypt Kafrelsheikh university Kafr Ash Shaykh

Sponsors (1)
Lead Sponsor Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gastric volume after surgery gastric reservoir volume after performance of laparoscopic sleeve gastrectomy 1 month
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