CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2 enrolled
Drug / intervention
Lap Nissen fundoplication with division of short gastric vessels +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00852098
NCT00852098N/ACompleted

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

Federal University of São Paulo·interventional·Posted Feb 26, 2009·Updated Feb 26, 2009

In Brief

A clinical study evaluating Lap Nissen fundoplication with division of short gastric vessels and Laparoscopic Nissen fundoplication without division of short gastric vessels for Gastroesophageal Reflux. Completed, enrolled 2 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil

Timeline

N/ACompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 26, 2009
Enrollment StartNov 1, 1997
Primary CompletionJan 1, 2000
Study CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 17.3 years ago

Interventions

Lap Nissen fundoplication with division of short gastric vesselsprocedure

Dividing short gastric vessels

Laparoscopic Nissen fundoplication without division of short gastric vesselsprocedure

non-dividing short gastric vessels