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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05069493
• Other study ID #: PATCH2
• Status: Completed
• Start date: September 15, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2022
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: June 30, 2022
• Est. primary completion date: March 30, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-Patients available at the time of follow-up

Exclusion Criteria:

• Deceased
• Declined participation

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia, Esophageal
• GERD
• Hernia
• Hernia, Hiatal
• Hiatal Hernia
• Quality of Life

Intervention

Procedure:
• simple suturing
Hiatal hernia repair by simple suturing of the diaphragmatic
• mesh
Hiatal hernia repair by tension-free mesh closure

Locations

Country	Name	City	State
Sweden	Ersta Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Ersta Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent hiatal hernia	The incidence of radiologically verified recurrent hiatal hernia	10 years
Secondary	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
Secondary	Gastrointestinal symptom rating scale (GSRS)	A validated questionnaire containing five dimensions of abdominal symptoms (gastroesophageal reflux, abdominal pain, indigestion, obstipation and diarrhea	10 years
Secondary	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
Secondary	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