Laparoscopic Gastric Plication Compared With Laparoscopic Sleeve Gastrectomy

Not Applicable

• Conditions: Morbid Obesity
• Interventions: Procedure: Laparoscopy surgery for morbid obesity

• Registration Number: NCT01293877
• Lead Sponsor: Bikkur Holim Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2011-02
• Study First Submitted: 2011-02-10
• Study First Submitted QC: 2011-02-10
• Last Update Submitted: 2011-02-10
• Study First Posted: 2011-02-11
• Last Update Posted: 2011-02-11
• Study Start: 2011-03
• Primary Completion: 2012-03
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LGP	Laparoscopy surgery for morbid obesity	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.
LSG	Laparoscopy surgery for morbid obesity	The patients in a total of one hundred will be schedule for laparoscopic sleeve gastrectomy. The is our control for development of the study.

Primary Outcome Measures

Name	Time	Method
Body Mass index loss	6mont.	The body mass index will be compared before the procedure and after at time frames.

Secondary Outcome Measures

Name	Time	Method
Complications Quality of life	6 month	complications compared one with the second procedure, qol, possibility to eat.

Trial Locations

Locations (1)

Bikur Holim Hospital; 🇮🇱 Jerusalem, Israel