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Laparoscopic Gastric Plication Operation for Patients With Severe or Morbid Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01207609
Recruitment Status : Completed
First Posted : September 23, 2010
Last Update Posted : February 2, 2016
Information provided by (Responsible Party):
Jaime Ponce MD, 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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Procedure: Laparoscopic Gastric Plication Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2010
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

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

Primary Outcome Measures :
  1. 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].

Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01207609

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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.
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Principal Investigator: Jaime Ponce, MD Hamilton Medical Center

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Responsible Party: Jaime Ponce MD, Director for Bariatric Surgery, Ponce, Jaime, M.D. Identifier: NCT01207609     History of Changes
Other Study ID Numbers: 10-9-001
First Posted: September 23, 2010    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jaime Ponce MD, Ponce, Jaime, M.D.:
Morbid Obesity
Bariatric Surgery
Laparoscopic Gastric Plication
Additional relevant MeSH terms:
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Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms