Laparoscopic Gastric Plication Operation for Patients With Severe or Morbid Obesity
The purpose of this study is to collect data prospectively on the safety and efficacy of the Laparoscopic Gastric Plication operation for patients with Severe or Morbid Obesity.
The 95% confidence interval for average percentage of weight loss and body mass index will be computed at 6 months, one year and then annually. Analysis of comorbid conditions changes, quality of life and adverse events will be performed. With 50 subjects in the study, limited power is expected and no formal hypothesis testing will be performed.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Study to Evaluate the Safety and Efficacy of the Laparoscopic Gastric Plication Operation for Patients With Severe or Morbid Obesity|
- Percent of excess weight loss [ Time Frame: 3 years ] [ Designated as safety issue: No ]
The primary efficacy variable is weight loss, which is measured in pounds and evaluated in terms of % excess weight loss (EWL) and body mass index (BMI), both of which will be measured at each follow-up visit.
Percent EWL is calculated by the following equation: [Weight Lost]/ [(Pre-op Weight)-(Ideal Body Weight)]. BMI is calculated by the equation: Weight (kg) divided by Height (m) squared [kg/m2].
- Status of comorbid conditions [ Time Frame: 3 years ] [ Designated as safety issue: No ]Improvement, resolution or worsening of pre-operative co-morbidities will be evaluated and reported at one year and annually up to 3 years. Status will be evaluated according to the necessity of medications to maintain normal physiologic values such as fasting serum glucose in diabetic patients, normal blood pressure in hypertensive patients, and use of a CPAP machine for patients with obstructive sleep apnea.
- Changes in quality of life scores from base line [ Time Frame: 3 years ] [ Designated as safety issue: No ]Status of quality of life will be evaluated objectively with a standardized SF-36 Health Survey
- Adverse events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Adverse events are intended to be volunteered by subjects or observed by the investigator. All adverse events are to be recorded on appropriate case report forms.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Experimental: Laparoscopic Gastric Plication
Collect data prospectively on the safety and efficacy of the Laparoscopic Gastric Plication operation for 50 patients with Severe or Morbid Obesity
Procedure: Laparoscopic Gastric Plication
The procedure is performed laparoscopic. The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3-5 cm from the pylorus and ending at the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected. At least two rows 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. A calibration tube or 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: NCT01207609
|United States, Georgia|
|Hamilton Medical Center|
|Dalton, Georgia, United States, 30722|
|United States, Tennessee|
|Chattanooga, Tennessee, United States, 37421|
|Principal Investigator:||Jaime Ponce, MD||Hamilton Medical Center|