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

Rijnstate Hospital

Status and phase: Not yet enrolling; Phase 4

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

Treatments: Device: Mesh repair; Procedure: Suture repair

Study type: Interventional

Funder types: Other

Identifiers

NCT05662735

NL82840.100.22

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 16 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Non-absorbable sutures

Active Comparator group

Description:

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

Treatment:

Procedure: Suture repair

Non-absorbable sutures and a TiMESH®

Active Comparator group

Description:

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.

Treatment:

Device: Mesh repair

Procedure: Suture repair