NCT00852098

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 1997-11-01
• Primary completion: 2000-01-01
• Completion: 2008-05-01
• First posted: 2009-02-26
• Last updated: 2009-02-26

Locations

2 sites across 1 country: Brazil