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

• Sponsor: Rijnstate Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05662735
• Collaborator: Rijnstate Vriendenfonds (Other)
• Enrollment: 60
• Arms: 2
• Anticipated Duration (Months): 3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hernia, Hiatal; Laparoscopic; Surgery; Recurrence; Mesh; Primary	Device: Mesh repair; Procedure: Suture repair	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomised controlled trialrandomised controlled trial
• Masking: Single (Participant)
• Masking Description: Patients were blinded for repair with sutures alone or sutures with mesh augmentation
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial of Laparoscopic Primary Diaphragm Repair With Sutures Alone Versus Sutures Reinforced With Mesh for Hiatus Hernia: A Long Term Follow-Up
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Non-absorbable sutures The hiatal hernia was corrected performing laparoscopic surgery. Primary repair of the hernia was done with non-absorbable sutures	Procedure: Suture repair; Primary laparoscopic repair of the hiatal hernia using non-absorbable sutures
Active Comparator: Non-absorbable sutures and a TiMESH® 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; Augmentation of hiatal hernia repair with TiMESH® reinforcement; Procedure: Suture repair; Primary laparoscopic repair of the hiatal hernia using non-absorbable sutures

Outcome Measures

Primary Outcome Measures

1. 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

1. Percentage of clinical recurrence of a hiatal hernia [5-10 years]

   Recurrence of symptoms related to a hiatal hernia measured by a questionnaire

2. Symptoms of gastroesophageal reflux disease [5-10 years]

   Percentage of participants that develop postoperative gastroesophageal reflux disease, measured by a questionnaire

3. 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'.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Rijnstate Hospital
• Rijnstate Vriendenfonds

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rijnstate Hospital
• ClinicalTrials.gov Identifier: NCT05662735
• Other Study ID Numbers: NL82840.100.22
• First Posted: Dec 22, 2022
• Last Update Posted: Dec 22, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Hernia; Recurrence; Hernia, Hiatal

Study Results

No Results Posted as of Dec 22, 2022