Laparoscopic Gastric Plication Compared With Laparoscopic Sleeve Gastrectomy (LGP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Bikkur Holim Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Bikkur Holim Hospital
ClinicalTrials.gov Identifier:
NCT01293877
First received: February 10, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Laparoscopic Gastric Plication for Treatment of Morbid Obesity

Resource links provided by NLM:


Further study details as provided by Bikkur Holim Hospital:

Primary Outcome Measures:
  • Body Mass index loss [ Time Frame: 6mont. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
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/
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/

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01293877

Contacts
Contact: Sergio G Susmallian, dr +972524637743 sergio9@bezeqint.net
Contact: Oleg Ponomarenko, dr +972525912710 oleg2308@012.net.il

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

No publications provided

Responsible Party: Sergio Susmallian, Bikkur Holim Hospital
ClinicalTrials.gov Identifier: NCT01293877     History of Changes
Other Study ID Numbers: GP111BH
Study First Received: February 10, 2011
Last Updated: February 10, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Bikkur Holim Hospital:
Laparoscopy
obesity
gastric
restrictive

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014