Laparoscopic Primary Diaphragm Versus Mesh Repair for Hiatus Hernia: a Long-Term Follow-Up

Study Overview
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Brief Summary
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Assessment of the recurrence of hiatal hernia five to ten years after repair using sutures versus sutures reinforced with non-absorbable mesh.

Official Title
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Randomized Controlled Trial of Laparoscopic Primary Diaphragm Repair With Sutures Alone Versus Sutures Reinforced With Mesh for Hiatus Hernia: A Long Term Follow-Up

Conditions
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Hernia, Hiatal, Laparoscopic, Surgery, Recurrence, Mesh, Primary

Intervention / Treatment
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* Device: Mesh repair
* Procedure: Suture repair


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomised controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-absorbable sutures<br>The hiatal hernia was corrected performing laparoscopic surgery. Primary repair of the hernia was done with non-absorbable sutures | Procedure: Suture repair<br>* Primary laparoscopic repair of the hiatal hernia using non-absorbable sutures<br>|
| Active Comparator: Non-absorbable sutures and a TiMESH®<br>The hiatal hernia was corrected performing laparoscopic surgery. Primary repair of the hernia was done with non-absorbable sutures and a TiMESH® to reinforce the repair. | Device: Mesh repair<br>* Augmentation of hiatal hernia repair with TiMESH® reinforcement<br>Procedure: Suture repair<br>* Primary laparoscopic repair of the hiatal hernia using non-absorbable sutures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of objective recurrence of a hiatal hernia | Objective measurement of the integrity of the hiatal hernia repair by CT-imaging | 5-10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of clinical recurrence of a hiatal hernia | Recurrence of symptoms related to a hiatal hernia measured by a questionnaire | 5-10 years | 
| Symptoms of gastroesophageal reflux disease | Percentage of participants that develop postoperative gastroesophageal reflux disease, measured by a questionnaire | 5-10 years | 
| Patient satisfaction | 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'. | 5-10 years |