Long-term Follow-up After Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing

Karolinska University Hospital

Status: Completed

Conditions: Quality of Life; Hiatal Hernia; GERD; Dysphagia, Esophageal

Treatments: Procedure: mesh; Procedure: simple suturing

Study type: Observational

Funder types: Other

Identifiers

NCT05069493

PATCH2

Details and patient eligibility

About

10 years of follow-up after surgery for hiatal hernia by tension-free mesh closure or simple suturing.

Full 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 previously 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 3 years after the surgery and secondary outcomes were dysphagia score, reflux control and quality of life. The study showed no differences between the groups regarding hiatal hernia recurrence but higher dysphagia scores for solid food at 3 years in mesh group.

This study is a long-term follow-up (>10 years) after surgery for hiatal hernia by tension-free mesh closure or simple suturing.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Patients available at the time of follow-up

Exclusion criteria

• Deceased
• Declined participation

Trial design

103 participants in 2 patient groups

Tension-free

Description:

Hiatal hernia repair by tension-free mesh closure

Treatment:

Procedure: mesh

Suturing

Description:

Hiatal hernia repair by simple suturing of the diaphragmatic

Treatment:

Procedure: simple suturing