NCT03730233

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

Completed NA Last updated 3 October 2023

What this trial tests

NA trial testing Hiatal hernia repair by tension-free mesh closure in Hiatal Hernia in 156 participants. Completed in 31 May 2022.

Timeline

11 January 2006

Primary endpoint
10 May 2010

31 May 2022

Quick facts

Lead sponsor	Karolinska Institutet
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	156
Start date	11 January 2006
Primary completion	10 May 2010
Estimated completion	31 May 2022

Drugs / interventions tested

• Hiatal hernia repair by tension-free mesh closure
• Hiatal hernia repair by simple suturing

Conditions studied

• Hiatal Hernia — all drugs for Hiatal Hernia →

Sponsor

Karolinska Institutet

Who can join

Adults 20 to 72, any sex, with Hiatal Hernia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Tension-free mesh versus suture-alone cruroplasty in antireflux surgery: a randomized, double-blind clinical trial.
   Analatos A, Håkanson BS, Lundell L, Lindblad M, et al · · 2020 · cited 29× · PMID 32936951 · DOI 10.1002/bjs.11917