Dysphagia, Esophageal, GERD, Hiatal Hernia, Quality of Life
Conditions
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.
Interventions
PROCEDUREsimple suturing
Hiatal hernia repair by simple suturing of the diaphragmatic
PROCEDUREmesh
Hiatal hernia repair by tension-free mesh closure
Sponsors
Ersta Hospital, Sweden
Karolinska University Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
-Patients available at the time of follow-up
Exclusion criteria
* Deceased * Declined participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent hiatal hernia | 10 years | The incidence of radiologically verified recurrent hiatal hernia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Number of patients who report daily intake of PPI at the time of the follow up Use of PPI use of PPI |
Countries
Sweden
Outcome results
None listed