NCT01207609

Laparoscopic Gastric Plication Operation for Patients With Severe or Morbid Obesity

A Prospective Study to Evaluate the Safety and Efficacy of the Laparoscopic Gastric Plication Operation for Patients With Severe or Morbid Obesity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Ponce, Jaime, M.D. · Individual
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Morbid Obesity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-11-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2010-09-23
• Last updated: 2016-02-02

Locations

2 sites across 1 country: United States