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

Completed

• Conditions: GERD; Hiatal Hernia; Quality of Life; Dysphagia, Esophageal
• Interventions: Procedure: simple suturing; Procedure: mesh

• Registration Number: NCT05069493
• Lead Sponsor: Karolinska University Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2021-09-15
• Study First Submitted: 2021-09-26
• Study First Submitted QC: 2021-09-26
• Study First Posted: 2021-10-06
• Primary Completion: 2022-03-30
• Study Completion: 2022-06-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-16
• Last Update Posted: 2022-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

-Patients available at the time of follow-up

Exclusion Criteria

• Deceased
• Declined participation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Suturing	simple suturing	Hiatal hernia repair by simple suturing of the diaphragmatic
Tension-free	mesh	Hiatal hernia repair by tension-free mesh closure

Primary Outcome Measures

Name	Time	Method
Recurrent hiatal hernia	10 years	The incidence of radiologically verified recurrent hiatal hernia

Secondary Outcome Measures

Name	Time	Method
Quality of Life, physical and mental score: SF-36	10 years	The Swedish version of the validated global Short Form -36 (SF-36) questionnaire was used and data are presented as physical and mental summary component scores (PCS and MCS, respectively)
Proton pump inhibitor (PPI)	10 years	Number of patients who report daily intake of PPI at the time of the follow up Use of PPI use of PPI
Dysphagia	10 years	Dysphagia for liquids and solids were recorded within a four-graded scale stating the frequency of dysphagia episodes with an arbitrary (empirical) cut off for clinical significance. The same dysphagia scoring was also used in a previous rct, from the same institution, comparing different types of antireflux procedures in open surgery.
Gastrointestinal symptom rating scale (GSRS)	10 years	A validated questionnaire containing five dimensions of abdominal symptoms (gastroesophageal reflux, abdominal pain, indigestion, obstipation and diarrhea

Trial Locations

Locations (1)

Ersta Hospital; 🇸🇪 Stockholm, Sweden