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

NCT ID: NCT05662735

Last Updated: 2022-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2023-06-30

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.

Detailed Description

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Conditions

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Hernia, Hiatal Laparoscopic Surgery Recurrence Mesh Primary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomised controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Patients were blinded for repair with sutures alone or sutures with mesh augmentation

Study Groups

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Non-absorbable sutures

The hiatal hernia was corrected performing laparoscopic surgery. Primary repair of the hernia was done with non-absorbable sutures

Group Type ACTIVE_COMPARATOR

Suture repair

Intervention Type PROCEDURE

Primary laparoscopic repair of the hiatal hernia using non-absorbable sutures

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.

Group Type ACTIVE_COMPARATOR

Mesh repair

Intervention Type DEVICE

Augmentation of hiatal hernia repair with TiMESH® reinforcement

Suture repair

Intervention Type PROCEDURE

Primary laparoscopic repair of the hiatal hernia using non-absorbable sutures

Interventions

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Mesh repair

Augmentation of hiatal hernia repair with TiMESH® reinforcement

Intervention Type DEVICE

Suture repair

Primary laparoscopic repair of the hiatal hernia using non-absorbable sutures

Intervention Type PROCEDURE

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rijnstate Vriendenfonds

UNKNOWN

Sponsor Role collaborator

Rijnstate Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Olivier Bouwmeester, MSc

Role: CONTACT

Phone: 088 - 005 8888

Email: [email protected]

Other Identifiers

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NL82840.100.22

Identifier Type: -

Identifier Source: org_study_id