Hernia, HiatalPhase 4PRIME LTFUNCT05662735
Laparoscopic Primary Diaphragm Versus Mesh Repair for Hiatus Hernia: a Long-Term Follow-Up
A Phase 4 study testing Mesh repair and Suture repair in people with Hernia, Hiatal and Laparoscopic, run by Rijnstate Hospital.
Trial summary
Assessment of the recurrence of hiatal hernia five to ten years after repair using sutures versus sutures reinforced with non-absorbable mesh. Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Hernia, Hiatal, Laparoscopic, Surgery
- What is being tested?
- Mesh repair and Suture repair
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Jun 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participant of the initial PRIME study
- Alive
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
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
Assessment of the recurrence of hiatal hernia five to ten years after repair using sutures versus sutures reinforced with non-absorbable mesh.
- Conditions
- Hernia, Hiatal, Laparoscopic, Surgery, Recurrence, Mesh, Primary
- Being tested
- Mesh repair, Suture repair
- Medical subject headings
- Hernia, Hiatal, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesh repairDevice
Augmentation of hiatal hernia repair with TiMESH® reinforcement
Suture repairProcedure or surgery
Primary laparoscopic repair of the hiatal hernia using non-absorbable sutures
| Study group | Role | What they receive |
|---|---|---|
| Non-absorbable sutures | Active comparator | The hiatal hernia was corrected performing laparoscopic surgery. Primary repair of the hernia was done with non-absorbable sutures Receives: Procedure: Suture repair |
| Non-absorbable sutures and a TiMESH® | Active comparator | 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. Receives: Device: Mesh repair; Procedure: Suture repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of objective recurrence of a hiatal hernia
Objective measurement of the integrity of the hiatal hernia repair by CT-imaging
Measured: 5-10 years
Secondary outcomes (3)
Percentage of clinical recurrence of a hiatal hernia
Recurrence of symptoms related to a hiatal hernia measured by a questionnaire
Measured: 5-10 years
Symptoms of gastroesophageal reflux disease
Percentage of participants that develop postoperative gastroesophageal reflux disease, measured by a questionnaire
Measured: 5-10 years
Patient satisfaction
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'.
Measured: 5-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study startMar 2023 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, HiatalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Rijnstate Vriendenfonds
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662735
- Sponsor's protocol ID
- NL82840.100.22
- Acronym
- PRIME LTFU
- Status last verified
- Dec 2022
- First submitted
- 7 Dec 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05662735
- Acronym / sponsor ID
- PRIME LTFU / NL82840.100.22
- Conditions
- Hernia, Hiatal, Laparoscopic, Surgery, Recurrence, Mesh, Primary
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- Rijnstate Vriendenfonds
- Study start
- Mar 2023 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of the recurrence of hiatal hernia five to ten years after repair using sutures versus sutures reinforced with non-absorbable mesh.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Non-absorbable sutures | Active comparator | Procedure: Suture repairThe 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 comparator | Device: Mesh repair, Procedure: Suture repairThe 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. |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Participant of the initial PRIME study
- Alive
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesh repairAugmentation of hiatal hernia repair with TiMESH® reinforcement | Device | Non-absorbable sutures and a TiMESH® |
| Suture repairPrimary laparoscopic repair of the hiatal hernia using non-absorbable sutures | Procedure or surgery | Non-absorbable sutures, Non-absorbable sutures and a TiMESH® |
Primary outcome
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
3 secondary outcomes
Percentage of clinical recurrence of a hiatal hernia
Time frame: 5-10 years
Symptoms of gastroesophageal reflux disease
Time frame: 5-10 years
Patient satisfaction
Time frame: 5-10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mesh repair and Suture repair in people with Hernia, Hiatal and Laparoscopic, run by Rijnstate Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier Bouwmeester, MSc (088 - 005 8888, obouwmeester@rijnstate.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of objective recurrence of a hiatal hernia (time frame: 5-10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.