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
Recruitment status was Not yet recruiting
Sponsor:
Bikkur Holim Hospital
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
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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
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 June 18, 2013