Laparoscopic Sleeve Gastrectomy Short Term Follow up
Primary Purpose
Morbid Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laparoscopic Sleeve Gastrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity
Eligibility Criteria
Inclusion Criteria:
- All patients,males and females with age (20-50 years old) with morbid obesity (BMI ≥ 40 kg/m2 or > 35 kg/m2 associated with co-morbidity), and are fit for laparoscopic surgery.
Exclusion Criteria:
- Patients having severe co-morbidity who are not fit for surgery or general anaesthesia.
- Patients with age below 20 years or above 50 years.
Sites / Locations
- AssiutURecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Laparoscopic Sleeve Gastrectomy
Arm Description
Laparoscopic sleeve gastrectomy for patients with morbid obesity using the gastro-intestinal anastomosis stapler.
Outcomes
Primary Outcome Measures
Assessment of excess weight loss
Assessment of excess weight loss six months after the operation.
Secondary Outcome Measures
Full Information
NCT ID
NCT03465956
First Posted
February 21, 2018
Last Updated
March 16, 2018
Sponsor
Mohamed Gamal Thabet
Collaborators
Assiut University
1. Study Identification
Unique Protocol Identification Number
NCT03465956
Brief Title
Laparoscopic Sleeve Gastrectomy Short Term Follow up
Official Title
Laparoscopic Sleeve Gastrectomy Short Term Follow up
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2018 (Anticipated)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohamed Gamal Thabet
Collaborators
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Laparoscopic Sleeve Gastrectomy (LSG), Also known as longitudinal or vertical gastrectomy.
LSG was initially considered a first-stage operation in high-risk patients before bilio-pancreatic diversion or Roux-en-Y gastric bypass surgery. However, LSG was subsequently found to be effective as a single procedure for treatment of morbid obesity.LSG functions mainly as a restrictive procedure in which about 75 % of the stomach is removed leaving a narrow gastric tube or sleeve. So, it limits the amount of food that can be eaten at one time via inducing early satiety after eating a small amount of food due to early distension of the fashioned gastric sleeve giving a sense of satiety, consequently losing excess body weight by time.Sleeve gastrectomy may also cause a decrease in appetite by reducing the amount of Ghrelin (hunger hormone) produced by the stomach.
Detailed Description
All patients,males and females with age (20-50 years old) with morbid obesity (BMI ≥ 40 kg/m2 or > 35 kg/m2 associated with co-morbidity) randomly admitted to Assiut University Hospital-General Surgery Department.
Pre-operative: Assessment of; BMI (Body Mass Index), Fasting Blood Glucose level (FBG), Associated Co-morbidities (as hypertensions & sleep apnea).
Operative (During Operation):
All patients undergo LSG by single team work with intra-operative oesophageal bougie 36 french with use of laparoscopic gastro-intestinal anastomosis(GIA) stapler.
Post-operative:
Patients are discharged from the hospital after they can start oral diet.
Post-operative evaluation of:
Complications:
Early complications: during the first 2 weeks after surgery,which include hemorrhage (intra-luminal or extra-luminal), staple line leak, vomiting and infection (surgical site infection or intra- abdominal abscess formation)
Late complications: from 2 weeks to 6 months post-operative, which include stricture of the gastric sleeve, gastro-esophageal reflux disease (GERD) and nutritional deficiencies.
Excess weight loss (EWL) by using BMI Follow up of patients at fifteen days, one month, two months, three months and six months after surgery.
Assessment of Blood Glucose level during visits.
Measurement of blood pressure during visits (if there is associated hypertension).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients,males and females with age (20-50 years old) with morbid obesity (BMI ≥ 40 kg/m2 or > 35 kg/m2 associated with co-morbidity).
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic Sleeve Gastrectomy
Arm Type
Other
Arm Description
Laparoscopic sleeve gastrectomy for patients with morbid obesity using the gastro-intestinal anastomosis stapler.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Sleeve Gastrectomy
Intervention Description
Laparoscopic Sleeve Gastrectomy using the gastro-intestinal anastomosis stapler.
Primary Outcome Measure Information:
Title
Assessment of excess weight loss
Description
Assessment of excess weight loss six months after the operation.
Time Frame
First six months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients,males and females with age (20-50 years old) with morbid obesity (BMI ≥ 40 kg/m2 or > 35 kg/m2 associated with co-morbidity), and are fit for laparoscopic surgery.
Exclusion Criteria:
Patients having severe co-morbidity who are not fit for surgery or general anaesthesia.
Patients with age below 20 years or above 50 years.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Gamal
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
AssiutU
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Gamal
Phone
01026674177
Email
gamal.m53@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21423553
Citation
Nosso G, Angrisani L, Saldalamacchia G, Cutolo PP, Cotugno M, Lupoli R, Vitolo G, Capaldo B. Impact of sleeve gastrectomy on weight loss, glucose homeostasis, and comorbidities in severely obese type 2 diabetic subjects. J Obes. 2011;2011:340867. doi: 10.1155/2011/340867. Epub 2011 Mar 8.
Results Reference
background
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Laparoscopic Sleeve Gastrectomy Short Term Follow up
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