Laparoscopic Internal Gastric Banding, New Simple and Costless Weight Loss Procedure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the effectiveness of laparoscopic internal gastric banding as a treatment for morbid obesity in comparison to laparoscopic sleeve gastrectomy

Detailed Description
-----------------
In this study 190 morbidly obese patients will be included and will randomly assign into 2 groups, group 1 will be operated by laparoscopic internal gastric banding and group 2 by laparoscopic sleeve gastrectomy, the patients will be followed up for 1 year to evaluate the effectiveness and drawbacks of laparoscopic internal gastric banding in comparison to laparoscopic sleeve gastrectomy, the investigators preparing to submit our study protocol to our institution ethical committee for approval to start the study

Official Title
-----------------
Study the Effectiveness and Safety of Laparoscopic Internal Gastric Banding, New Simple and Costless Weight Loss Procedure, in Comparison to Laparoscopic Sleeve Gastrectomy

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Procedure: Laparoscopic internal gastric banding
* Procedure: laparoscopic sleeve gastrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity Approval to share in the study Patients fit for laparoscopic surgery Exclusion Criteria: Patient age less than 18 or more than 50 years old Refusal to share in the study Unfit for surgery patients with gastroesophageal reflux disease clinically or by investigation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic internal gastric banding<br>Laparoscopic internal gastric banding | Procedure: Laparoscopic internal gastric banding<br>* Laparoscopic internal gastric banding<br>|
| Active Comparator: Laparoscopic sleeve gastrectomy<br>Laparoscopic sleeve gastrectomy | Procedure: laparoscopic sleeve gastrectomy<br>* laparoscopic sleeve gastrectomy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of the technique | the incidence of introperative and early postoperative complications | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time | the operative time from skin to skin | 12 hours | 
| Hospital stay | Time of hospital stay | 30 days | 
| total cost | the total cost of the technique by US dollar and its early complications | 16 weeks | 
| Metabolic effect | Effect of the procedure on blood sugar, serum lipid and hypertension | 6-12 months |