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

NCT00852098 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2009-02-26

No results posted yet for this study

Summary

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.

Conditions

  • Gastroesophageal Reflux

Interventions

PROCEDURE

Lap Nissen fundoplication with division of short gastric vessels

Dividing short gastric vessels

PROCEDURE

Laparoscopic Nissen fundoplication without division of short gastric vessels

non-dividing short gastric vessels

Sponsors & Collaborators

  • Hospital State Public

    collaborator UNKNOWN

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • José Carlos DelGrande, MD · Federal University of São Paulo

  • Michelle L DeOliveira, MD · Federal University of São Paulo

  • Francisco Farah, MD · Federal University of São Paulo

  • Renato Lupinacci, MD · Hospital State Public Server São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-11-30
Primary Completion
2000-01-31
Completion
2008-05-31

Countries

  • Brazil

Study Locations

More Related Trials

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 NCT00852098 on ClinicalTrials.gov