Laparoscopic Gastric Plication Compared With Laparoscopic Sleeve Gastrectomy

Study Overview
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Brief Summary
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The study must be performed in 100 patients suffering from morbid obesity, the procedure will be performed under general anesthesia doing two or three layers of suture to achieves gastric imbrication until transform the stomach to a sleeve. The patients will be followed during the time for 6 month, 1 year, two years and 5 years.

Detailed Description
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The patients will be selected with BMI more than 40, the operation will be primary between 18 to 60 years old. The patients will be informed about the procedure and different options. The patients will be in admission board for two or three days and any event will be recorded. the follow up will be recorded by the nurse, the surgeon and the dietitian, laboratory parameter includes CBC, T4,T3, TSH, ferrum, transferrin, ferritin, vit. B12, SMA, lipids, The end point will be the EBW achieved and events occurred.

Official Title
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Laparoscopic Gastric Plication for Treatment of Morbid Obesity

Conditions
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Morbid Obesity

Intervention / Treatment
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* Procedure: Laparoscopy surgery for morbid obesity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 40 or more Age between 18-60 years old ASA score 1-2 Exclusion Criteria: BMI less than 40 Severe illness Psychiatric disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LGP<br>Patient underwent surgery for morbid obesity treatment between 18 to 60 years, and BMI of 40 ore more will divided in two groups, one hundred will be schedule for laparoscopic gastric plication. Our theory for this arm is that the procedure can offer the same results than the second arm with less cost and safety, reversibility included. | Procedure: Laparoscopy surgery for morbid obesity<br>* The intervention will compare the 2 restrictive procedures one sleeve gastrectomy and gastric plication/<br>|
| Other: LSG<br>The patients in a total of one hundred will be schedule for laparoscopic sleeve gastrectomy. The is our control for development of the study. | Procedure: Laparoscopy surgery for morbid obesity<br>* The intervention will compare the 2 restrictive procedures one sleeve gastrectomy and gastric plication/<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass index loss | The body mass index will be compared before the procedure and after at time frames. | 6mont. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications Quality of life | complications compared one with the second procedure, qol, possibility to eat. | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopy, obesity, gastric, restrictive