NCT02625077

Brief 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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2015

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 9, 2015

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

3 years

First QC Date

November 15, 2015

Last Update Submit

March 23, 2017

Conditions

Gastroesophageal RefluxHernia, Hiatal

Keywords

ValvuloplastyFundoplicationAcid refluxGERDReflux diseaseHiatal hernia

Outcome Measures

Primary Outcomes (1)

  • Success rate, objective

    Defined as % of patients with normal values of reflux measured by pH and impedance monitoring

    3 months post-operative

Secondary Outcomes (7)

  • Success rate, subjective

    3 months post-operative, 1 year post-operative

  • Percent of patients with complaints of functional dysphagia according to the Rome III criteria

    3 months post-operative, 1 year post-operative

  • Cost-effectiveness

    1 year post-operative

  • Mortality rate

    30 days

  • Complication rate

    During surgery

  • +2 more secondary outcomes

Study Arms (2)

Laparoscopic valvuloplasty

EXPERIMENTAL

Via laparoscopy, using three sutures a part of the esophagus is folded (similar to the way parts of a telescope slide in each other) into the stomach, creating a valve on the inside to prevent gastric acid to enter the esophagus.

Procedure: Laparoscopic gastroesophageal valvuloplasty

Laparoscopic Toupet fundoplication

ACTIVE COMPARATOR

Via laparoscopy, the entire stomach is mobilized and folded around itself posteriorly, creating a partial (270 degrees) fundoplication.

Procedure: Laparoscopic Toupet fundoplication

Interventions

Laparoscopic gastroesophageal valvuloplastyPROCEDURE
Laparoscopic valvuloplasty
Laparoscopic Toupet fundoplicationPROCEDURE
Laparoscopic Toupet fundoplication

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Objectively proven GERD (by gastroscopy and/or 24-hour pH and/or impedance monitoring)
  • Age ≥18
  • Written informed consent for study participation

You may not qualify if:

  • BMI ≥ 30
  • Hiatal hernia \>3cm
  • Achalasia
  • Previous gastric surgery
  • Previous esophageal surgery
  • Inability to understand the Dutch language
  • Inability to understand and/or fill in the questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meander Medical Center

Amersfoort, Utrecht, 3813 TZ, Netherlands

Location

Related Links

MeSH Terms

Conditions

Gastroesophageal RefluxHernia, Hiatal

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHernia, DiaphragmaticInternal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Werner A Draaisma, MD, PhD

    Meander Medical Center

    STUDY DIRECTOR

  • Ivo AM Broeders, MD, PhD

    Meander Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Leader

Study Record Dates

First Submitted

November 15, 2015

First Posted

December 9, 2015

Study Start

January 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

March 27, 2017

Record last verified: 2017-03

Locations

NL(1)