search
Back to results

Laparoscopic Gastric Plication Compared With Laparoscopic Sleeve Gastrectomy (LGP)

Primary Purpose

Morbid Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Laparoscopy surgery for morbid obesity
Sponsored by
Bikkur Holim Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Laparoscopy, obesity, gastric, restrictive

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bikur Holim Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

LGP

LSG

Arm Description

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.

The patients in a total of one hundred will be schedule for laparoscopic sleeve gastrectomy. The is our control for development of the study.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Complications Quality of life
complications compared one with the second procedure, qol, possibility to eat.

Full Information

First Posted
February 10, 2011
Last Updated
February 10, 2011
Sponsor
Bikkur Holim Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01293877
Brief Title
Laparoscopic Gastric Plication Compared With Laparoscopic Sleeve Gastrectomy
Acronym
LGP
Official Title
Laparoscopic Gastric Plication for Treatment of Morbid Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Bikkur Holim Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Laparoscopy, obesity, gastric, restrictive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LGP
Arm Type
Other
Arm Description
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.
Arm Title
LSG
Arm Type
Other
Arm Description
The patients in a total of one hundred will be schedule for laparoscopic sleeve gastrectomy. The is our control for development of the study.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopy surgery for morbid obesity
Intervention Description
The intervention will compare the 2 restrictive procedures one sleeve gastrectomy and gastric plication/
Primary Outcome Measure Information:
Title
Body Mass index loss
Description
The body mass index will be compared before the procedure and after at time frames.
Time Frame
6mont.
Secondary Outcome Measure Information:
Title
Complications Quality of life
Description
complications compared one with the second procedure, qol, possibility to eat.
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sergio G Susmallian, dr
Phone
+972524637743
Email
sergio9@bezeqint.net
First Name & Middle Initial & Last Name or Official Title & Degree
Oleg Ponomarenko, dr
Phone
+972525912710
Email
oleg2308@012.net.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio g Susmallian, dr
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bikur Holim Hospital
City
Jerusalem
ZIP/Postal Code
91004
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

Laparoscopic Gastric Plication Compared With Laparoscopic Sleeve Gastrectomy

We'll reach out to this number within 24 hrs