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

Study Overview
=================
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.

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

Conditions
-----------------
GERD, Hiatal Hernia, Dysphagia, Esophageal, Quality of Life

Intervention / Treatment
-----------------
* Procedure: simple suturing
* Procedure: mesh


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patients available at the time of follow-up Exclusion Criteria: Deceased Declined participation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tension-free<br>Hiatal hernia repair by tension-free mesh closure | Procedure: mesh<br>* Hiatal hernia repair by tension-free mesh closure<br>|
| Suturing<br>Hiatal hernia repair by simple suturing of the diaphragmatic | Procedure: simple suturing<br>* Hiatal hernia repair by simple suturing of the diaphragmatic<br>|

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 |