NCT01293877

Laparoscopic Gastric Plication Compared With Laparoscopic Sleeve Gastrectomy

Laparoscopic Gastric Plication for Treatment of Morbid Obesity

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Bikkur Holim Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Morbid Obesity

Interventions

Type	Name	Description
PROCEDURE	Laparoscopy surgery for morbid obesity	The intervention will compare the 2 restrictive procedures one sleeve gastrectomy and gastric plication/

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-02-11
• Last updated: 2011-02-11

Locations

1 site across 1 country: Israel