ClinicalTrials.Veeva

Menu

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

F

Federal University of São Paulo

Status

Completed

Conditions

Gastroesophageal Reflux

Treatments

Procedure: Laparoscopic Nissen fundoplication without division of short gastric vessels
Procedure: Lap Nissen fundoplication with division of short gastric vessels

Study type

Interventional

Funder types

Other

Identifiers

NCT00852098
1069/06

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • objective gastroesophageal reflux in adults

Exclusion criteria

  • esophageal motility disorder
  • hard stenosis
  • previous antireflux surgery

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

2 participants in 2 patient groups

1
Active Comparator group
Description:
dividing short gastric vessels
Treatment:
Procedure: Lap Nissen fundoplication with division of short gastric vessels
2
Active Comparator group
Description:
non-dividing short gastric vessels
Treatment:
Procedure: Laparoscopic Nissen fundoplication without division of short gastric vessels

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems