Clinical Trial: Laparoscopic Gastric Plication Operation for Patients With Severe or Morbid Obesity

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective Study to Evaluate the Safety and Efficacy of the Laparoscopic Gastric Plication Operation for Patients With Severe or Morbid Obesity

Brief Summary:

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.


Detailed Summary: The laparoscopic gastric plication (LGP) is a new restrictive bariatric surgical technique that has the potential to eliminate the complications associated with other restrictive procedures (i.e., gastric banding, sleeve gastrectomy) by creating a restriction without the use of an implant and without performing gastric resection. LGP is notably similar to a sleeve gastrectomy in that it generates a gastric tube by means of eliminating the greater curvature but does so without gastric resection.
Sponsor: Ponce, Jaime, M.D.

Current Primary Outcome: Percent of excess weight loss [ Time Frame: 3 years ]

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].



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Status of comorbid conditions [ Time Frame: 3 years ]
    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 ]
    Status of quality of life will be evaluated objectively with a standardized SF-36 Health Survey
  • Adverse events [ Time Frame: 3 years ]
    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.


Original Secondary Outcome: Same as current

Information By: Ponce, Jaime, M.D.

Dates:
Date Received: September 21, 2010
Date Started: November 2010
Date Completion:
Last Updated: February 1, 2016
Last Verified: February 2016