Laparoscopic Gastric Plication Operation for Patients With Severe or Morbid Obesity

A Prospective Study to Evaluate the Safety and Efficacy of the 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 Overview

• Status: Completed
• Conditions: Morbid Obesity
• Intervention / Treatment: Procedure: Laparoscopic Gastric Plication

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Dalton, Georgia, United States, 30722
      • Hamilton Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Chattanooga Bariatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.; Other Names: Laparoscopic Greater Curvature Plication; Vertical Gastric Plication; Gastric Sleeve Plication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of excess weight loss	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].	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Status of comorbid conditions	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.	3 years
Changes in quality of life scores from base line	Status of quality of life will be evaluated objectively with a standardized SF-36 Health Survey	3 years
Adverse events	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.	3 years

Collaborators and Investigators

• Sponsor: Ponce, Jaime, M.D.
• Investigators: Principal Investigator: Jaime Ponce, MD, Hamilton Medical Center

Publications and helpful links

General Publications

• Ramos A, Galvao Neto M, Galvao M, Evangelista LF, Campos JM, Ferraz A. Laparoscopic greater curvature plication: initial results of an alternative restrictive bariatric procedure. Obes Surg. 2010 Jul;20(7):913-8. doi: 10.1007/s11695-010-0132-0.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: September 21, 2010
• First Submitted That Met QC Criteria: September 22, 2010
• First Posted (Estimate): September 23, 2010

Study Record Updates

• Last Update Posted (Estimate): February 2, 2016
• Last Update Submitted That Met QC Criteria: February 1, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Obesity; Morbid Obesity; Bariatric Surgery; Laparoscopic Gastric Plication
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: 10-9-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No