Back to resultsVolumetric Pouch Study After Laparoscopic Sleeve Gastrectomy
Primary Purpose
Bariatric Surgery Candidate, Obesity, Morbid
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
sleeve gastrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Bariatric Surgery Candidate focused on measuring Laparoscopic Sleeve Gastrectomy, gastric reservoir, Multi-slice computer tomography
Eligibility Criteria
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
Sites / Locations
- Kafrelsheikh university
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
sleeve gastrectomy followed by volumetric assessment
Arm Description
Outcomes
Primary Outcome Measures
Gastric volume after surgery
gastric reservoir volume after performance of laparoscopic sleeve gastrectomy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04880902
Brief Title
Volumetric Pouch Study After Laparoscopic Sleeve Gastrectomy
Official Title
Volumetric Pouch Study After Laparoscopic Sleeve Gastrectomy: Effect of the Pouch Size on Excessive Weight Loss and Weight Regain
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate, Obesity, Morbid
Keywords
Laparoscopic Sleeve Gastrectomy, gastric reservoir, Multi-slice computer tomography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sleeve gastrectomy followed by volumetric assessment
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
sleeve gastrectomy
Intervention Description
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
Primary Outcome Measure Information:
Title
Gastric volume after surgery
Description
gastric reservoir volume after performance of laparoscopic sleeve gastrectomy
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kafrelsheikh university
City
Kafr Ash Shaykh
ZIP/Postal Code
33516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Volumetric Pouch Study After Laparoscopic Sleeve Gastrectomy
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