Surgical Intervention in Bariatric Patients: Excess Weight Loss in the Morbidly Obese Following Gastric Plication
Up to 45 men and women who meet the entry criteria will undergo the gastric plication procedure. The study will assess subject excess weight loss (%EWL) following the study procedure at 1, 3, 6, 12, 18, 24, 30 and 36 months.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Surgical Intervention in Bariatric Patients: Excess Weight Loss in the Morbidly Obese Following Gastric Plication|
- Mean Percent Excess Weight Loss at 3 Years With Last Observation Carried Forward [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Percent excess weight change from baseline to 3 years was calculated as (the baseline weight minus the weight at 3 years) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.
One-sided, alpha=0.025, t-test of the Percent Excess Weight Loss (EWL) at 3-years to demonstrate non-inferiority to the target weight loss value of 41.1%EWL
|Study Start Date:||November 2009|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
|Gastric Plication Surgery||
Procedure: Gastric Plication
A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.
The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.
At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01077193
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|The Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|OB Klinika, a.s.|
|Prague, Czech Republic|