Morbid obesity. Morbid obesity
Conditions
Interventions
Intervention 1: One-row Laparoscopic Gastric Plication. It is done
by invagination of sections of gastric wall from the
perimeter of greater curvature. Intervention 2: Two-row Laparoscopic Gastric Pli
Treatment - Surgery
One-row Laparoscopic Gastric Plication. It is done
by invagination of sections of gastric wall from the
perimeter of greater curvature.
Two-row Laparoscopic Gastric Plication. It is done
by invagination of sections of gastric wall from the
perimeter of greater curvature.
Sponsors
Vice chancellor for research, Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: morbid obesity ( BMI>40 kg/m2 or BMI>35kg/m2 with co-existing morbidities ); age 18 to 65; previous unsuccessful weight loss attempts Exclusion criteria: previous restrictive or malabsorptive procedure for obesity treatment; previous gastric surgery; history of anti-reflux surgery; pregnancy
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of excess weight loss. Timepoint: 3,6,12,18,24 months postoperatively. Method of measurement: (primary weight - weight at follow-up)*100/excess weight.;Percent of bmi loss. Timepoint: 3,6,12,18,24 months postoperatively. Method of measurement: ( Initial BMI - Follow-up BMI) x 100/(Initial BMI - 25). | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of two procedures in improving obesity related comorbidities. Timepoint: 3,6, 12, 18, 24 months postoperatively. Method of measurement: history, physical examination, lab data.;Early and late complications of each procedure. Timepoint: from postoperative day to 24 months postoperatively. Method of measurement: history, physical examination, lab data.;Percent of weight loss. Timepoint: 3, 6, 12, 18, 24 months postoperatively. Method of measurement: (baseline weight - weight at follow-up)*100/weight. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactReza Heidari
School of medicine, Tehran University of Medical Sciences
Outcome results
None listed