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Resolution of Comorbidities, Safety and Efficacy of Greater Curvature Plication in Obese Patients.

NCT01512940 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-03-13

No results posted yet for this study

Summary

Various gastric restrictive procedures have evolved over the years but abandoned due to poor long term weight loss, food intolerance or severe gastroesophageal reflux. Laparoscopic gastric plication or laparoscopic greater curvature placation ( LGCP) has recently been done as an alternative to the other restrictive procedures. But the short and long term safety and efficacy outcomes of LGCP is not well documented in current literature. American society of metabolic and bariatric surgery ( ASMBS) guidelines state that LGCP procedures should be considered investigational at this time and should be performed under a study protocol with third party oversight (e.g. IRB) to ensure continuous evaluation of patient safety and to review adverse events and outcomes.

The objective of this study will be to demonstrate feasibility , short term and long term safety and efficacy of LGCP . This will be done by achieving gastric restriction by infolding of stomach and thereby achieving good weight loss .

Conditions

Interventions

PROCEDURE

Laparoscopic Greater Curvature Plication

The greater curvature of the stomach is separated from the greater omentum. At least two rows of at least five continuous stitches will be placed about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure. The two tissue bites of an individual stitch will be centered about the intended fold line. Subsequent stitches will be uniformly spaced distally along the length of the fold. The second row of sutures will be placed across the fold line created by the previous row of sutures in the same fashion as the first row. Up to 2 additional rows may be added as required to achieve this result (for a total of up to 4 rows). Upon completion of the procedure, the section of the stomach infolded by the sutures will be inspected using the endoscope.

Sponsors & Collaborators

  • Singh, Kuldeep, M.D., P.A.

    lead INDIV

Principal Investigators

  • Kuldeep Singh, MD · Kuldeep Singh, MDPA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT01512940 on ClinicalTrials.gov