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Laparoscopic Gastric Plication Operation for Patients With Severe or Morbid Obesity

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jaime Ponce MD, Ponce, Jaime, M.D.
ClinicalTrials.gov Identifier:
NCT01207609
First received: September 21, 2010
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Morbid Obesity
 Procedure: Laparoscopic Gastric Plication

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ponce, Jaime, M.D.:

Primary Outcome Measures:
  • 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].



Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: November 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01207609

Locations
United States, Georgia
Hamilton Medical Center
Dalton, Georgia, United States, 30722
United States, Tennessee
Chattanooga Bariatrics
Chattanooga, Tennessee, United States, 37421
Sponsors and Collaborators
Ponce, Jaime, M.D.
Investigators
Principal Investigator: Jaime Ponce, MD Hamilton Medical Center
  More Information

Publications:

Responsible Party: Jaime Ponce MD, Director for Bariatric Surgery, Ponce, Jaime, M.D.
ClinicalTrials.gov Identifier: NCT01207609     History of Changes
Other Study ID Numbers: 10-9-001
Study First Received: September 21, 2010
Last Updated: January 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ponce, Jaime, M.D.:
Obesity
Morbid Obesity
Bariatric Surgery
Laparoscopic Gastric Plication

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013