- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05662735
Laparoscopic Primary Diaphragm Versus Mesh Repair for Hiatus Hernia: a Long-Term Follow-Up (PRIME LTFU)
December 15, 2022 updated by: Rijnstate Hospital
Randomized Controlled Trial of Laparoscopic Primary Diaphragm Repair With Sutures Alone Versus Sutures Reinforced With Mesh for Hiatus Hernia: A Long Term Follow-Up
Assessment of the recurrence of hiatal hernia five to ten years after repair using sutures versus sutures reinforced with non-absorbable mesh.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Olivier Bouwmeester, MSc
- Phone Number: 088 - 005 8888
- Email: obouwmeester@rijnstate.nl
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 98 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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
|
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.
|
Primary laparoscopic repair of the hiatal hernia using non-absorbable sutures
Augmentation of hiatal hernia repair with TiMESH® reinforcement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of objective recurrence of a hiatal hernia
Time Frame: 5-10 years
|
Objective measurement of the integrity of the hiatal hernia repair by CT-imaging
|
5-10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of clinical recurrence of a hiatal hernia
Time Frame: 5-10 years
|
Recurrence of symptoms related to a hiatal hernia measured by a questionnaire
|
5-10 years
|
Symptoms of gastroesophageal reflux disease
Time Frame: 5-10 years
|
Percentage of participants that develop postoperative gastroesophageal reflux disease, measured by a questionnaire
|
5-10 years
|
Patient satisfaction
Time Frame: 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'.
|
5-10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2023
Primary Completion (Anticipated)
June 1, 2023
Study Completion (Anticipated)
June 1, 2023
Study Registration Dates
First Submitted
December 7, 2022
First Submitted That Met QC Criteria
December 15, 2022
First Posted (Actual)
December 22, 2022
Study Record Updates
Last Update Posted (Actual)
December 22, 2022
Last Update Submitted That Met QC Criteria
December 15, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL82840.100.22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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