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Laparoscopic Gastric Plication Compared With Laparoscopic Sleeve Gastrectomy (LGP)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by Bikkur Holim Hospital.
Recruitment status was:  Not yet recruiting
Information provided by:
Bikkur Holim Hospital Identifier:
First received: February 10, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
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 Intervention
Morbid Obesity
Procedure: Laparoscopy surgery for morbid obesity

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Laparoscopic Gastric Plication for Treatment of Morbid Obesity

Further study details as provided by Bikkur Holim Hospital:

Primary Outcome Measures:
  • Body Mass index loss [ Time Frame: 6mont. ]
    The body mass index will be compared before the procedure and after at time frames.

Secondary Outcome Measures:
  • Complications Quality of life [ Time Frame: 6 month ]
    complications compared one with the second procedure, qol, possibility to eat.

Estimated Enrollment: 200
Study Start Date: March 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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/
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/

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.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
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
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Please refer to this study by its identifier: NCT01293877

Contact: Sergio G Susmallian, dr +972524637743
Contact: Oleg Ponomarenko, dr +972525912710

Bikur Holim Hospital
Jerusalem, Israel, 91004
Sponsors and Collaborators
Bikkur Holim Hospital
Principal Investigator: Sergio g Susmallian, dr
  More Information

Responsible Party: Sergio Susmallian, Bikkur Holim Hospital Identifier: NCT01293877     History of Changes
Other Study ID Numbers: GP111BH
Study First Received: February 10, 2011
Last Updated: February 10, 2011

Keywords provided by Bikkur Holim Hospital:

Additional relevant MeSH terms:
Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms processed this record on May 25, 2017