Laparoscopic Nissen Fundoplication Comparing Division Versus Non-Division of Short Gastric Vessels

February 25, 2009 updated by: Federal University of São Paulo

Randomized Clinic Trial of Total Fundoplication and Fundal Mobilization With or Without Division of Short Gastric Vessels: Long-Term Endoscopic Evaluation

Recently, total fundoplication followed by laparoscopic esophageal hiatoplasty has been the most common surgical treatment for gastro-esophageal reflux. Although this procedure is effective, some patients still develop complications. Indeed, dividing the short gastric vessels is claimed by many authors to confer benefit to patients even it could not be proved in other studies. In an attempt to evaluate the role of dividing the short gastric vessels and its long-term impact on the surgical treatment of the gastro-esophageal reflux, the investigators initiated a randomized clinical trial to clarify this important fact. Patients were recruited for this trial and short-term results had been already published in a national journal. The investigators are now registering this study which particularly focuses on the endoscopic outcome evaluated on long-term basis after gastro-esophageal reflux surgical treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04023-071
        • Federal University of Sao Paulo - Unifesp
      • São Paulo, Brazil, 04025-000
        • State Public Server of São Paulo Hospital (HSPE)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • objective gastroesophageal reflux in adults

Exclusion Criteria:

  • esophageal motility disorder
  • hard stenosis
  • previous antireflux surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
dividing short gastric vessels
Procedure: Lap Nissen fundoplication with division of short gastric vessels
Dividing short gastric vessels
Other Names:
  • Fundoplication, Gastroesophageal Reflux,Surgery
Active Comparator: 2
non-dividing short gastric vessels
Procedure: Laparoscopic Nissen fundoplication without division of short gastric vessels
non-dividing short gastric vessels
Other Names:
  • Fundoplication, Gastroesophageal Reflux,Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate outcomes after Laparoscopic Nissen comparing division and non-division of short gastric vessels.
Time Frame: two years
two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Long-term clinical and endoscopic outcome
Time Frame: 8-10 years
8-10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

Hospital State Public

Investigators

  • Study Director: José Carlos DelGrande, MD, Federal University of São Paulo
  • Study Chair: Michelle L DeOliveira, MD, Federal University of São Paulo
  • Principal Investigator: Francisco Farah, MD, Federal University of São Paulo
  • Study Chair: Renato Lupinacci, MD, Hospital State Public Server São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1997

Primary Completion (Actual)

January 1, 2000

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

February 25, 2009

First Submitted That Met QC Criteria

February 25, 2009

First Posted (Estimate)

February 26, 2009

Study Record Updates

Last Update Posted (Estimate)

February 26, 2009

Last Update Submitted That Met QC Criteria

February 25, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1069/06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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