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Laparoscopic Gastric Plication Operation for Patients With Severe or Morbid Obesity

NCT01207609 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2016-02-02

No results posted yet for this study

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.

Conditions

  • Morbid Obesity

Interventions

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.

Sponsors & Collaborators

  • Ponce, Jaime, M.D.

    lead INDIV

Principal Investigators

  • Jaime Ponce, MD · Hamilton Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01207609 on ClinicalTrials.gov