Laparoscopic Gastric Plication Compared With Laparoscopic Sleeve Gastrectomy
LGP
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2011
CompletedFirst Posted
Study publicly available on registry
February 11, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFebruary 11, 2011
February 1, 2011
1 year
February 10, 2011
February 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Body Mass index loss
The body mass index will be compared before the procedure and after at time frames.
6mont.
Secondary Outcomes (1)
Complications Quality of life
6 month
Study Arms (2)
LGP
OTHERPatient 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.
LSG
OTHERThe patients in a total of one hundred will be schedule for laparoscopic sleeve gastrectomy. The is our control for development of the study.
Interventions
The intervention will compare the 2 restrictive procedures one sleeve gastrectomy and gastric plication/
Eligibility Criteria
You may qualify if:
- BMI 40 or more
- Age between 18-60 years old
- ASA score 1-2
You may not qualify if:
- BMI less than 40
- Severe illness
- Psychiatric disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bikur Holim Hospital
Jerusalem, Jerusalem, 91004, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sergio g Susmallian, dr
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 10, 2011
First Posted
February 11, 2011
Study Start
March 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
February 11, 2011
Record last verified: 2011-02