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

Phase 4

Not yet recruiting

• Conditions: Mesh; Primary; Hernia, Hiatal; Surgery; Laparoscopic; Recurrence
• Interventions: Procedure: Suture repair; Device: Mesh repair

• 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

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2022-12-15
• Last Update Submitted: 2022-12-15
• Study First Posted: 2022-12-22
• Last Update Posted: 2022-12-22
• Study Start: 2023-03
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-absorbable sutures	Suture repair	The hiatal hernia was corrected performing laparoscopic surgery. Primary repair of the hernia was done with non-absorbable sutures
Non-absorbable sutures and a TiMESH®	Mesh repair	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.
Non-absorbable sutures and a TiMESH®	Suture repair	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.

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'.