Laparoscopic Gastric Plication Operation for Patients With Severe or Morbid Obesity

Not Applicable

Completed

• Conditions: Morbid Obesity
• Interventions: Procedure: Laparoscopic Gastric Plication

• Registration Number: NCT01207609
• Lead Sponsor: Ponce, Jaime, M.D.

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 Description

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.

Study Timeline

• Study First Submitted: 2010-09-21
• Study First Submitted QC: 2010-09-22
• Study First Posted: 2010-09-23
• Study Start: 2010-11
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-01
• Last Update Posted: 2016-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Age: 18 - 60 years
• BMI 35-39.9 kg/m2 with one or more severe co-morbid conditions or BMI 40-55 kg/m2
• Willingness to comply with dietary restrictions required by the protocol
• History of obesity for at least 5 years
• History of at least 6 months of documented failures with traditional non-surgical weight loss methods
• Willingness to follow protocol requirements which include: signing the informed consent form, completing routine follow-up visits for the study duration, and completing all pre- and post-operative laboratory and diagnostics tests in addition to the quality of life questionnaire
• If female with childbearing potential, using an appropriate form of contraception

Exclusion Criteria

• Age less than 18, age greater than 60
• Pregnancy
• History of major depressive disorder or psychosis
• Previous bariatric surgery or previous gastric surgery
• Presence of achalasia
• Any condition that, in the judgment of the investigator, would place a subject at undue risk, or could potentially compromise the results or interpretation of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laparoscopic Gastric Plication	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

Primary Outcome Measures

Name	Time	Method
Percent of excess weight loss	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 \[kg/m2\].

Secondary Outcome Measures

Name	Time	Method
Status of comorbid conditions	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	3 years	Status of quality of life will be evaluated objectively with a standardized SF-36 Health Survey
Adverse events	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.

Trial Locations

Locations (2)

Hamilton Medical Center; 🇺🇸 Dalton, Georgia, United States

Chattanooga Bariatrics; 🇺🇸 Chattanooga, Tennessee, United States