Laparoscopic Primary Diaphragm Versus Mesh Repair for Hiatus Hernia: a Long-Term Follow-Up
PRIME LTFU
Randomized Controlled Trial of Laparoscopic Primary Diaphragm Repair With Sutures Alone Versus Sutures Reinforced With Mesh for Hiatus Hernia: A Long Term Follow-Up
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
Assessment of the recurrence of hiatal hernia five to ten years after repair using sutures versus sutures reinforced with non-absorbable mesh.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2023
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2022
CompletedFirst Posted
Study publicly available on registry
December 22, 2022
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedDecember 22, 2022
December 1, 2022
3 months
December 7, 2022
December 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Percentage of clinical recurrence of a hiatal hernia
5-10 years
Symptoms of gastroesophageal reflux disease
5-10 years
Patient satisfaction
5-10 years
Study Arms (2)
Non-absorbable sutures
ACTIVE COMPARATORThe hiatal hernia was corrected performing laparoscopic surgery. Primary repair of the hernia was done with non-absorbable sutures
Non-absorbable sutures and a TiMESH®
ACTIVE COMPARATORThe 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.
Interventions
Augmentation of hiatal hernia repair with TiMESH® reinforcement
Primary laparoscopic repair of the hiatal hernia using non-absorbable sutures
Eligibility Criteria
You may qualify if:
- Participant of the initial PRIME study
- Alive
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rijnstate Hospitallead
- Rijnstate Vriendenfondscollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Patients were blinded for repair with sutures alone or sutures with mesh augmentation
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2022
First Posted
December 22, 2022
Study Start
March 1, 2023
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
December 22, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share