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Valvuloplasty as Alternative to Toupet Fundoplication for GERD

NCT02625077 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-03-27

No results posted yet for this study

Summary

This monocenter randomized controlled trial aims to compare postoperative outcomes of a laparoscopic valvuloplasty with a Toupet fundoplication in patients with GERD with a maximum hiatal hernia of 3cm. In addition, an economic evaluation of the new intervention will be done in order to determine cost-effectiveness and costs per quality-adjusted life-year (QALY).

Conditions

  • Gastroesophageal Reflux
  • Hernia, Hiatal

Interventions

PROCEDURE

Laparoscopic gastroesophageal valvuloplasty

PROCEDURE

Laparoscopic Toupet fundoplication

Sponsors & Collaborators

  • Meander Medical Center

    lead OTHER

Principal Investigators

  • Werner A Draaisma, MD, PhD · Meander Medical Center

  • Ivo AM Broeders, MD, PhD · Meander Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • Netherlands

Study Locations

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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 NCT02625077 on ClinicalTrials.gov