Gastroesophageal Reflux
Conditions
Keywords
Fundoplication, gastroesophageal reflux, gastric vessels, surgery
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.
Interventions
PROCEDURELap Nissen fundoplication with division of short gastric vessels
Dividing short gastric vessels
PROCEDURELaparoscopic Nissen fundoplication without division of short gastric vessels
non-dividing short gastric vessels
Sponsors
Hospital State Public
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* objective gastroesophageal reflux in adults
Exclusion criteria
* esophageal motility disorder * hard stenosis * previous antireflux surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate outcomes after Laparoscopic Nissen comparing division and non-division of short gastric vessels. | two years |
Secondary
| Measure | Time frame |
|---|---|
| Long-term clinical and endoscopic outcome | 8-10 years |
Countries
Brazil
Outcome results
None listed