Laparoscopic Primary Diaphragm Versus Mesh Repair for Hiatus Hernia: a Long-Term Follow-Up
- Conditions
- MeshPrimaryHernia, HiatalSurgeryLaparoscopicRecurrence
- Registration Number
- NCT05662735
- Lead Sponsor
- Rijnstate Hospital
- Brief Summary
Assessment of the recurrence of hiatal hernia five to ten years after repair using sutures versus sutures reinforced with non-absorbable mesh.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Participant of the initial PRIME study
- Alive
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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'.