Hernia, Hiatal, Laparoscopic, Mesh, Primary, Recurrence, Surgery
Conditions
Brief summary
Assessment of the recurrence of hiatal hernia five to ten years after repair using sutures versus sutures reinforced with non-absorbable mesh.
Interventions
DEVICEMesh repair
Augmentation of hiatal hernia repair with TiMESH® reinforcement
PROCEDURESuture repair
Primary laparoscopic repair of the hiatal hernia using non-absorbable sutures
Sponsors
Rijnstate Vriendenfonds
Rijnstate Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients were blinded for repair with sutures alone or sutures with mesh augmentation
Intervention model description
randomised controlled trial
Eligibility
Sex/Gender
ALL
Age
16 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Participant of the initial PRIME study * Alive
Exclusion criteria
* No informed consent * Additional hiatal hernia repair surgery during the follow-up period * Pregnancy * Patients that have stated they do not want to be approached for follow-up research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of objective recurrence of a hiatal hernia | 5-10 years | Objective measurement of the integrity of the hiatal hernia repair by CT-imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of clinical recurrence of a hiatal hernia | 5-10 years | Recurrence of symptoms related to a hiatal hernia measured by a questionnaire |
| Symptoms of gastroesophageal reflux disease | 5-10 years | Percentage of participants that develop postoperative gastroesophageal reflux disease, measured by a questionnaire |
| Patient satisfaction | 5-10 years | Overall satisfaction with surgical outcome measured by a questionnaire, on a scale from 0 to 10, where 0 means very unsatisfied with the outcome of the operation and 10 means very satisfied with the outcome of the operation. An additional question will be asked that assesses if the patient would undergo the operation again and can be answered by a simple 'yes' or 'no'. |
Contacts
Primary ContactOlivier Bouwmeester, MSc
Outcome results
None listed