Morbid Obesity
Conditions
Keywords
Laparoscopy, obesity, gastric, restrictive
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.
Interventions
PROCEDURELaparoscopy surgery for morbid obesity
The intervention will compare the 2 restrictive procedures one sleeve gastrectomy and gastric plication/
Sponsors
Bikkur Holim Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass index loss | 6mont. | The body mass index will be compared before the procedure and after at time frames. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications Quality of life | 6 month | complications compared one with the second procedure, qol, possibility to eat. |
Countries
Israel
Contacts
Primary ContactSergio G Susmallian, dr
Backup ContactOleg Ponomarenko, dr
Outcome results
None listed