Back to resultsLaparoscopic Gastric Plication Operation for Patients With Severe or Morbid Obesity
Primary Purpose
Morbid Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laparoscopic Gastric Plication
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity focused on measuring Obesity, Morbid Obesity, Bariatric Surgery, Laparoscopic Gastric Plication
Eligibility 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
Sites / Locations
- Hamilton Medical Center
- Chattanooga Bariatrics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Laparoscopic Gastric Plication
Arm Description
Collect data prospectively on the safety and efficacy of the Laparoscopic Gastric Plication operation for 50 patients with Severe or Morbid Obesity
Outcomes
Primary Outcome Measures
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].
Secondary Outcome Measures
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.
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
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.
Full Information
NCT ID
NCT01207609
First Posted
September 21, 2010
Last Updated
February 1, 2016
Sponsor
Ponce, Jaime, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT01207609
Brief Title
Laparoscopic Gastric Plication Operation for Patients With Severe or Morbid Obesity
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 Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ponce, Jaime, M.D.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Obesity, Morbid Obesity, Bariatric Surgery, Laparoscopic Gastric Plication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic Gastric Plication
Arm Type
Experimental
Arm Description
Collect data prospectively on the safety and efficacy of the Laparoscopic Gastric Plication operation for 50 patients with Severe or Morbid Obesity
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Gastric Plication
Other Intervention Name(s)
Laparoscopic Greater Curvature Plication, Vertical Gastric Plication, Gastric Sleeve Plication
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent of excess weight loss
Description
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].
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Status of comorbid conditions
Description
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.
Time Frame
3 years
Title
Changes in quality of life scores from base line
Description
Status of quality of life will be evaluated objectively with a standardized SF-36 Health Survey
Time Frame
3 years
Title
Adverse events
Description
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.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime Ponce, MD
Organizational Affiliation
Hamilton Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Medical Center
City
Dalton
State/Province
Georgia
ZIP/Postal Code
30722
Country
United States
Facility Name
Chattanooga Bariatrics
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20407932
Citation
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.
Results Reference
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Laparoscopic Gastric Plication Operation for Patients With Severe or Morbid Obesity
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