Hernia, AbdominalNCT03846661
Nationwide Long-term Outcome Surveillance of Physiomesh® vs. Other Meshes in Laparoscopic Incisional Hernia Repair
A study testing Physiomesh in people with Hernia, Abdominal and Recurrence, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
The primary aim of the present study was to show how a national clinical register combined with other nationwide administrative registers may serve as a tool for pre- and post-marketing evaluation of new mesh and mesh fixation products for hernia surgery, using Physiomesh® versus other meshes designed for laparoscopic… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Hernia, Abdominal, Recurrence, Postoperative Complications
- What is being tested?
- Physiomesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,338 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2010to 1 Feb 2019
- Phase
- Interventional
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients registered in the Danish Hernia Database for a laparoscopic incisional hernia repair
Who cannot join
- If not registered for a laparoscopic incisional hernia repair in the Danish Hernia Database
Trial locations and contacts
1 site in 1 country.
About this study
The primary aim of the present study was to show how a national clinical register combined with other nationwide administrative registers may serve as a tool for pre- and post-marketing evaluation of new mesh and mesh fixation products for hernia surgery, using Physiomesh® versus other meshes designed for laparoscopic hernia repair as an example.
Read the detailed description
All adult (≥18 yrs) patients registered in the Danish Hernia Database (DHB) who underwent elective primary laparoscopic incisional hernia repair between January 1st 2010 and December 31st 2016.
To obtain 100% follow-up data from DHB will be combined with administrative data from the Danish National Patient register.
Patients will be followed from initial hernia repair until reoperation for recurrence, death, emigration outside Denmark or end of follow-up (november 2017).
Physiomesh and other mesh repairs will be propensity score matched. Each patient in the Physiomesh® group will be matched with two patients treated with one of the other synthetic meshes. The Propensity score includes age, sex, year of surgery, diagnosis of chronic obstructive pulmonary disease, diagnosis of diabetes, diagnosis of obesity, Charlson comorbidity index and size of hernia defect
The primary outcome: Difference in risk for a reoperation for recurrence between patients operated with Physiomesh® and patients operated with another synthetic mesh designed for laparoscopic repair.
The secondary outcome will be rates of 30-day readmission, 30-day reoperation for complications (excluding hernia recurrence) as well as 30- and 90-day mortality.
- Conditions
- Hernia, Abdominal, Recurrence, Postoperative Complications
- Being tested
- Physiomesh
- Medical subject headings
- Hernia, Abdominal, Recurrence, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiomeshDevice
Also called other mesh
difference in risk for recurrence and postoperative complication
| Study group | Role | What they receive |
|---|---|---|
| Physiomesh | Active comparator | Patients undergoing laparoscopic incisional hernia repair reinforced with a Physiomesh. Receives: Device: Physiomesh |
| other mesh | No intervention | Patients undergoing laparoscopic incisional hernia repair reinforced with other meshes than Physiomesh. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-operation for recurrence rate
Measured: up to 84 months
Secondary outcomes (2)
30-day readmission rate
Measured: 30 day
30-reoperation for complication rate
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start1 Jan 2010
- Primary completion1 Nov 2017
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, AbdominalStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Register study
- Masking
- None (open label)
- Enrolment
- 3,338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederik Helgstrand, Zealand University Hospital
- Investigators
- Frederik Helgstrand, MD, Principal investigator, Dept. Surgery, Zealand university Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846661
- Sponsor's protocol ID
- FH115
- Status last verified
- Feb 2019
- First submitted
- 4 Feb 2019
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nationwide Long-term Outcome Surveillance of Physiomesh® vs. Other Meshes in Laparoscopic Incisional Hernia Repair
- ClinicalTrials.gov ID
- NCT03846661
- Acronym / sponsor ID
- FH115
- Conditions
- Hernia, Abdominal, Recurrence, Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,338 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 20 Feb 2019 (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.
The primary aim of the present study was to show how a national clinical register combined with other nationwide administrative registers may serve as a tool for pre- and post-marketing evaluation of new mesh and mesh fixation products for hernia surgery, using Physiomesh® versus other meshes designed for laparoscopic hernia repair as an example.
Detailed description
All adult (≥18 yrs) patients registered in the Danish Hernia Database (DHB) who underwent elective primary laparoscopic incisional hernia repair between January 1st 2010 and December 31st 2016.
To obtain 100% follow-up data from DHB will be combined with administrative data from the Danish National Patient register.
Patients will be followed from initial hernia repair until reoperation for recurrence, death, emigration outside Denmark or end of follow-up (november 2017).
Physiomesh and other mesh repairs will be propensity score matched. Each patient in the Physiomesh® group will be matched with two patients treated with one of the other synthetic meshes. The Propensity score includes age, sex, year of surgery, diagnosis of chronic obstructive pulmonary disease, diagnosis of diabetes, diagnosis of obesity, Charlson comorbidity index and size of hernia defect
The primary outcome: Difference in risk for a reoperation for recurrence between patients operated with Physiomesh® and patients operated with another synthetic mesh designed for laparoscopic repair.
The secondary outcome will be rates of 30-day readmission, 30-day reoperation for complications (excluding hernia recurrence) as well as 30- and 90-day mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Register study
| Arm | Type | Receives |
|---|---|---|
| Physiomesh | Active comparator | Device: PhysiomeshPatients undergoing laparoscopic incisional hernia repair reinforced with a Physiomesh. |
| other mesh | No intervention | –Patients undergoing laparoscopic incisional hernia repair reinforced with other meshes than Physiomesh. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients registered in the Danish Hernia Database for a laparoscopic incisional hernia repair
Key exclusion criteria (1 listed)
- If not registered for a laparoscopic incisional hernia repair in the Danish Hernia Database
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 |
|---|---|---|
| PhysiomeshAlso: other meshdifference in risk for recurrence and postoperative complication | Device | Physiomesh |
Primary outcome
Re-operation for recurrence rate
Time frame: up to 84 months
2 secondary outcomes
30-day readmission rate
Time frame: 30 day
30-reoperation for complication rate
Time frame: 30 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
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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.
Frederik Helgstrand, MD principal investigator
Dept. Surgery, Zealand university Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiomesh in people with Hernia, Abdominal and Recurrence, run by Zealand University Hospital at 1 site in Denmark.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-operation for recurrence rate (time frame: up to 84 months). 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 27 Feb 2019.