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Clinical Trials/NCT03465956
NCT03465956UnknownNot Applicable

Laparoscopic Sleeve Gastrectomy Short Term Follow up

Mohamed Gamal Thabet1 site in 1 country20 target enrollmentStarted: April 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
Assessment of excess weight loss

Study Overview

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:

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Laparoscopic Sleeve Gastrectomy

Other

Laparoscopic sleeve gastrectomy for patients with morbid obesity using the gastro-intestinal anastomosis stapler.

Intervention: Laparoscopic Sleeve Gastrectomy (Procedure)

Outcomes

Primary Outcomes

Assessment of excess weight loss

Time Frame: First six months after surgery

Assessment of excess weight loss six months after the operation.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Mohamed Gamal Thabet
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Mohamed Gamal Thabet

Principal investigator

Assiut University

Study Sites (1)

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