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Comparison of Total and Partial Fundoplication During Surgery of Patients With Gastroesophageal Reflux Disease

NCT03659487 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2018-10-29

No results posted yet for this study

Summary

460 patients who are scheduled for surgical treatment of gastroesophageal reflux disease (GERD) participate in the study following the usual preoperative Clinical routines (Medical history, endoscopy with biopsies, esophageal manometry with 24 hour pH (acidity) registration ). Patients are randomized to fundoplication according to Nissen or modified Toupet. Postoperatively, patients are monitored after 6 weeks 12, 36, 24 and 60 months.

Conditions

  • Reflux, Gastroesophageal

Interventions

PROCEDURE

Nissen

Laparoscopic total (Nissen) fundoplication

PROCEDURE

Toupét

Laparoscopic posterior 270 degrees partial fundoplication

Sponsors & Collaborators

Principal Investigators

  • Anders Thorell, professor · Karolinska Institut

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-11-30
Primary Completion
2011-04-30
Completion
2018-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03659487 on ClinicalTrials.gov