Long-term Follow-up After Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing
Study Details
Study Description
Brief Summary
10 years of follow-up after surgery for hiatal hernia by tension-free mesh closure or simple suturing.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Recurrent hiatal hernia [10 years]
The incidence of radiologically verified recurrent hiatal hernia
Secondary Outcome Measures
- 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
- 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]
Use of PPI Use of PPI use of PPI
Eligibility Criteria
Criteria
Inclusion Criteria:
-Patients available at the time of follow-up
Exclusion Criteria:
-
Deceased
-
Declined participation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ersta Hospital | Stockholm | Sweden |
Sponsors and Collaborators
- Karolinska University Hospital
- Ersta Hospital, Sweden
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PATCH2