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Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing

NCT03730233 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2023-10-03

No results posted yet for this study

Summary

One-hundred and fifty-nine patients undergoing Nissen fundoplication for symptomatic gastro-oesophageal reflux disease (GORD), who had a concomitant hiatal hernia of \> 2 cm axial length, were randomized to closure of the diaphragmatic hiatus with either crural sutures alone or tension-free closure with a non-absorbable mesh. Primary outcome variable was the incidence of radiologically verified recurrent hiatal hernia. Secondary outcomes were per-and postoperative complications and courses, symptomatic recurrence rate, use of PPI, postoperative oesophageal acid exposure and Quality of Life.

Conditions

  • Hiatal Hernia

Interventions

PROCEDURE

Hiatal hernia repair by tension-free mesh closure

PROCEDURE

Hiatal hernia repair by simple suturing

Sponsors & Collaborators

Principal Investigators

  • Anders Thorell, Professor · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-11
Primary Completion
2010-05-10
Completion
2022-05-31

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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 NCT03730233 on ClinicalTrials.gov