Volumetric Pouch Study After Laparoscopic Sleeve Gastrectomy

Sponsor

Kafrelsheikh University (Other)

Overall Status

Completed

CT.gov ID

NCT04880902

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bariatric Surgery Candidate Obesity, Morbid	Procedure: sleeve gastrectomy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2018

Actual Primary Completion Date :

Oct 1, 2020

Actual Study Completion Date :

Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: sleeve gastrectomy followed by volumetric assessment	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

Arm

Intervention/Treatment

Experimental: sleeve gastrectomy followed by volumetric assessment

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

Outcome Measures

Primary Outcome Measures

Gastric volume after surgery [1 month]
gastric reservoir volume after performance of laparoscopic sleeve gastrectomy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kafrelsheikh university	Kafr Ash Shaykh		Egypt	33516

Sponsors and Collaborators

Kafrelsheikh University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Ahmed Elkhoby, Dr, assistant lecturer of General Surgery, Kafrelsheikh University

ClinicalTrials.gov Identifier:

NCT04880902

Other Study ID Numbers:

01006786978123

First Posted:

May 11, 2021

Last Update Posted:

May 11, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mohamed Ahmed Elkhoby, Dr, assistant lecturer of General Surgery, Kafrelsheikh University

Laparoscopic Sleeve Gastrectomy

gastric reservoir

Multi-slice computer tomography

Additional relevant MeSH terms:

Obesity, Morbid

Study Results

No Results Posted as of May 11, 2021