LGP: Laparoscopic Gastric Plication Compared With Laparoscopic Sleeve Gastrectomy

• Sponsor: Bikkur Holim Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01293877
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 16.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity	Procedure: Laparoscopy surgery for morbid obesity	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Laparoscopic Gastric Plication for Treatment of Morbid Obesity
• Study Start Date: Mar 1, 2011
• Anticipated Primary Completion Date: Mar 1, 2012
• Anticipated Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: LGP 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; The intervention will compare the 2 restrictive procedures one sleeve gastrectomy and gastric plication/
Other: LSG 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; The intervention will compare the 2 restrictive procedures one sleeve gastrectomy and gastric plication/

Outcome Measures

Primary Outcome Measures

1. Body Mass index loss [6mont.]

   The body mass index will be compared before the procedure and after at time frames.

Secondary Outcome Measures

1. Complications Quality of life [6 month]

   complications compared one with the second procedure, qol, possibility to eat.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bikur Holim Hospital	Jerusalem		Israel	91004

Sponsors and Collaborators

• Bikkur Holim Hospital

Investigators

• Principal Investigator: Sergio g Susmallian, dr,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01293877
• Other Study ID Numbers: GP111BH
• First Posted: Feb 11, 2011
• Last Update Posted: Feb 11, 2011
• Last Verified: Feb 1, 2011

• Keywords provided by , ,: Laparoscopy; obesity; gastric; restrictive
• Additional relevant MeSH terms: Obesity; Obesity, Morbid

Study Results

No Results Posted as of Feb 11, 2011