Laparoscopic Gastric Plication Compared With Laparoscopic Sleeve Gastrectomy
- Conditions
- Morbid Obesity
- Registration Number
- NCT01293877
- Lead Sponsor
- Bikkur Holim Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- BMI 40 or more
- Age between 18-60 years old
- ASA score 1-2
- BMI less than 40
- Severe illness
- Psychiatric disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Body Mass index loss 6mont. The body mass index will be compared before the procedure and after at time frames.
- Secondary Outcome Measures
Name Time Method Complications Quality of life 6 month complications compared one with the second procedure, qol, possibility to eat.
Trial Locations
- Locations (1)
Bikur Holim Hospital
🇮🇱Jerusalem, Israel
Bikur Holim Hospital🇮🇱Jerusalem, Israel