Laparoscopic Gastric Plication Operation for Patients With Severe or Morbid Obesity

NCT01207609 | Completed

• 1 other identifier: 10-9-001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Morbid Obesity

Keywords

Obesity; Morbid Obesity; Bariatric Surgery; Laparoscopic Gastric Plication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Status of comorbid conditions

  3 years

• Changes in quality of life scores from base line

  3 years

• Adverse events

  3 years

Study Arms (1)

Laparoscopic Gastric Plication

EXPERIMENTAL

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

Interventions

Laparoscopic Gastric Plication PROCEDURE

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.

Also known as: Laparoscopic Greater Curvature Plication, Vertical Gastric Plication, Gastric Sleeve Plication

Laparoscopic Gastric Plication

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ponce, Jaime, M.D.: lead

Study Sites (2)

Hamilton Medical Center

Dalton, Georgia, 30722, United States

Location

Chattanooga Bariatrics

Chattanooga, Tennessee, 37421, United States

Location

Related Publications (1)

• 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.

  PMID: 20407932 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jaime Ponce, MD

  Hamilton Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director for Bariatric Surgery

Study Record Dates

• First Submitted: September 21, 2010
• First Posted: September 23, 2010
• Study Start: November 1, 2010
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 2, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)