Laparoscopic Gastric Plication Compared With Laparoscopic Sleeve Gastrectomy

NCT ID: NCT01293877

Last Updated: 2011-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-03-31

Brief Summary

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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

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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

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Morbid Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type OTHER

Laparoscopy surgery for morbid obesity

Intervention Type PROCEDURE

The intervention will compare the 2 restrictive procedures one sleeve gastrectomy and gastric plication/

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.

Group Type OTHER

Laparoscopy surgery for morbid obesity

Intervention Type PROCEDURE

The intervention will compare the 2 restrictive procedures one sleeve gastrectomy and gastric plication/

Interventions

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Laparoscopy surgery for morbid obesity

The intervention will compare the 2 restrictive procedures one sleeve gastrectomy and gastric plication/

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bikkur Holim Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bikkur Holim Hospital

Principal Investigators

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Sergio g Susmallian, dr

Role: PRINCIPAL_INVESTIGATOR

Locations

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Bikur Holim Hospital

Jerusalem, Jerusalem, Israel

Site Status

Countries

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Israel

Central Contacts

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Sergio G Susmallian, dr

Role: CONTACT

+972524637743

Oleg Ponomarenko, dr

Role: CONTACT

+972525912710

Other Identifiers

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GP111BH

Identifier Type: -

Identifier Source: org_study_id

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