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

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux
• Interventions: Procedure: Lap Nissen fundoplication with division of short gastric vessels; Procedure: Laparoscopic Nissen fundoplication without division of short gastric vessels

• Registration Number: NCT00852098
• Lead Sponsor: Federal University of São Paulo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-11
• Primary Completion: 2000-01
• Study Completion: 2008-05
• Status Verified: 2009-02
• Study First Submitted: 2009-02-25
• Study First Submitted QC: 2009-02-25
• Last Update Submitted: 2009-02-25
• Study First Posted: 2009-02-26
• Last Update Posted: 2009-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• objective gastroesophageal reflux in adults

Exclusion Criteria

• esophageal motility disorder
• hard stenosis
• previous antireflux surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Lap Nissen fundoplication with division of short gastric vessels	dividing short gastric vessels
2	Laparoscopic Nissen fundoplication without division of short gastric vessels	non-dividing short gastric vessels

Primary Outcome Measures

Name	Time	Method
Evaluate outcomes after Laparoscopic Nissen comparing division and non-division of short gastric vessels.	two years

Secondary Outcome Measures

Name	Time	Method
Long-term clinical and endoscopic outcome	8-10 years

Trial Locations

Locations (2)

Federal University of São Paulo - UNIFESP; 🇧🇷 São Paulo, Brazil

State Public Server of São Paulo Hospital (HSPE); 🇧🇷 São Paulo, Brazil