Laparoscopic Gastric Plication Compared With Laparoscopic Sleeve Gastrectomy

Morbid Obesity Clinical Trial

— LGP  

Official title:

Laparoscopic Gastric Plication for Treatment of Morbid Obesity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01293877
• Other study ID #: GP111BH
• Status: Not yet recruiting
• Phase: N/A
• First received: February 10, 2011
• Last updated: February 10, 2011
• Start date: March 2011
• Est. completion date: March 2012

Study information

• Verified date: February 2011
• Source: Bikkur Holim Hospital
• Contact: Sergio G Susmallian, dr
• Phone: +972524637743
• Email: sergio9[@]bezeqint.net
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• Laparoscopy surgery for morbid obesity
The intervention will compare the 2 restrictive procedures one sleeve gastrectomy and gastric plication/

Locations

Country	Name	City	State
Israel	Bikur Holim Hospital	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Bikkur Holim Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass index loss	The body mass index will be compared before the procedure and after at time frames.	6mont.	No
Secondary	Complications Quality of life	complications compared one with the second procedure, qol, possibility to eat.	6 month	No