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Laparoscopic Sleeve Gastrectomy Short Term Follow up

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ClinicalTrials.gov Identifier: NCT03465956
Recruitment Status : Unknown
Verified March 2018 by Mohamed Gamal Thabet, Assiut University.
Recruitment status was:  Recruiting
First Posted : March 15, 2018
Last Update Posted : March 20, 2018
Sponsor:
Collaborator:
Assiut University
Information provided by (Responsible Party):
Mohamed Gamal Thabet, Assiut University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Morbid Obesity Procedure: Laparoscopic Sleeve Gastrectomy Not Applicable

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:

  1. Complications:

    1. 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)
    2. 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.
  2. 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.
  3. Assessment of Blood Glucose level during visits.
  4. Measurement of blood pressure during visits (if there is associated hypertension).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Laparoscopic Sleeve Gastrectomy Short Term Follow up
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : July 2020
Arms and Interventions
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Arm Intervention/treatment
Laparoscopic Sleeve Gastrectomy
Laparoscopic sleeve gastrectomy for patients with morbid obesity using the gastro-intestinal anastomosis stapler.
 Procedure: Laparoscopic Sleeve Gastrectomy
Laparoscopic Sleeve Gastrectomy using the gastro-intestinal anastomosis stapler.


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of excess weight loss [ Time Frame: First six months after surgery ]
    Assessment of excess weight loss six months after the operation.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03465956


Locations
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Egypt
AssiutU Recruiting
Assiut, Egypt
Contact: Mohamed Gamal    01026674177    gamal.m53@yahoo.com   
Sponsors and Collaborators
Mohamed Gamal Thabet
Assiut University
Investigators
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Principal Investigator: Mohamed Gamal Assiut University
More Information
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Publications:

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Responsible Party: Mohamed Gamal Thabet, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03465956    
Other Study ID Numbers: Mohamed gamal
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
 Nutrition Disorders
Overweight
Body Weight