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

Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing of the Diaphragmatic Hiatus. Long-term (>10 Years) Follow-up of a Randomized, Double-blind Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Quality of Life; Hiatal Hernia; GERD; Dysphagia, Esophageal
• Intervention / Treatment: Procedure: mesh; Procedure: 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 Type: Observational
• Enrollment (Actual): 103

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Ersta Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who were included in the previous study (hiatal hernia repair by tension-free mesh closure or simple suturing) and are available for inclusion at the long-term follow-up.

Description

Inclusion Criteria:

-Patients available at the time of follow-up

Exclusion Criteria:

• Deceased
• Declined participation

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tension-free; Hiatal hernia repair by tension-free mesh closure	Procedure: mesh; Hiatal hernia repair by tension-free mesh closure
Suturing; Hiatal hernia repair by simple suturing of the diaphragmatic	Procedure: simple suturing; Hiatal hernia repair by simple suturing of the diaphragmatic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent hiatal hernia	The incidence of radiologically verified recurrent hiatal hernia	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dysphagia	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.	10 years
Gastrointestinal symptom rating scale (GSRS)	A validated questionnaire containing five dimensions of abdominal symptoms (gastroesophageal reflux, abdominal pain, indigestion, obstipation and diarrhea	10 years
Quality of Life, physical and mental score: SF-36	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)	10 years
Proton pump inhibitor (PPI)	Number of patients who report daily intake of PPI at the time of the follow up Use of PPI use of PPI	10 years

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Collaborators: Ersta Hospital, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: September 26, 2021
• First Submitted That Met QC Criteria: September 26, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 16, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Esophageal Diseases; Hernia, Diaphragmatic; Internal Hernia; Hernia; Hernia, Hiatal; Deglutition Disorders
• Other Study ID Numbers: PATCH2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No