Clinical trial NCT01207609: 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
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: Obesity
Morbid Obesity
Bariatric Surgery
Laparoscopic Gastric Plication
Lead sponsor: Ponce, Jaime, M.D.
Sponsor class: INDIV
First posted: 2010-09-23
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percent of excess weight loss
timeFrame: 3 years
Secondary outcomes:
measure: Status of comorbid conditions
timeFrame: 3 years
measure: Changes in quality of life scores from base line
timeFrame: 3 years
measure: Adverse events
timeFrame: 3 years
Other outcomes:
Locations:
city: Dalton
country: United States
facility: Hamilton Medical Center
state: Georgia
city: Chattanooga
country: United States
facility: Chattanooga Bariatrics
state: Tennessee
Study officials:
affiliation: Hamilton Medical Center
name: Jaime Ponce, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.