Laparoscopic Gastric Plication Compared With Laparoscopic Sleeve Gastrectomy (LGP)

Bikkur Holim Hospital

Status: Unknown

Conditions: Morbid Obesity

Treatments: Procedure: Laparoscopy surgery for morbid obesity

Study type: Interventional

Funder types: Other

Identifiers

NCT01293877

GP111BH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

200 participants in 2 patient groups

LGP

Other group

Description:

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.

Treatment:

Procedure: Laparoscopy surgery for morbid obesity

LSG

Other group

Description:

The patients in a total of one hundred will be schedule for laparoscopic sleeve gastrectomy. The is our control for development of the study.

Treatment:

Procedure: Laparoscopy surgery for morbid obesity