Hernia, InguinalPhase 4NCT00827944
Parietex Progrip Study
A Phase 4 study testing Parietex Progrip and Low weight polypropylene mesh in people with Hernia, Inguinal, run by Medtronic - MITG at 9 sites in 5 countries.
Trial summary
The objective of the study is to evaluate pain and disabling complications inducing social consequences in primary inguinal hernia ProGrip mesh repair compared to Lichtenstein repair with lightweight polypropylene mesh. Read more about this study
- Who is it for?
- Ages 31 to 74 years, men only
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- Parietex Progrip and Low weight polypropylene mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 603 participants
- Where
- 9 sitesin 5 countries
- Study dates
- Oct 2008to Oct 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 31 to 74 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All male patients at participating centers with a primary, uncomplicated inguinal hernia.
- Collar of the defect ≤ 4 cm
- Signed informed consent
- Bilateral inguinal hernia
- Recurrence
Who cannot join
- 30 years ≥ Age ≥ 75 years
- Emergency procedure
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
United Kingdom3 sites
Western Infirmary
Glasgow, G11 6NT
Imperial College London / Faculty of Medecine
London, W2 1NY
Derriford Hospital
Plymouth, PL6
Germany2 sites
Klinikum Bremen-Mitte
Bremen, 28177
Herz-Jesu-Krankenhaus gGmbH, Chirurgische Klinik
Fulda, D- 36039 Fulda
Sweden2 sites
Medical Center Linköping
Linköping, 582 24
Centre of clinical research
Västeras-, 721 89
About this study
Official title: ProGrip Mesh Repair Versus Lichtenstein Mesh Repair: a Comparative Randomized Study in Primary Inguinal Hernia
The objective of the study is to evaluate pain and disabling complications inducing social consequences in primary inguinal hernia ProGrip mesh repair compared to Lichtenstein repair with lightweight polypropylene mesh.
Read the detailed description
- Patients in ProGrip group will be treated with self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
- Patients in Lichtenstein group will be treated with lightweight Polypropylene meshes requiring fixation by sutures.
- Study participation will start at signature of informed consent and each patient will be assessed before surgery. A close follow-up will be performed: 7 days (questionnaires and phone call), 1 month (clinical visit), 3 months (questionnaires and phone call), and final evaluation at 12 months (clinical visit) after surgery, which will end the participation to the study.
- 600 adult males divided in 2 groups requiring primary uncomplicated elective inguinal hernia mesh repair will be included in the study. Patients will be stratified by center.
- Conditions
- Hernia, Inguinal
- Being tested
- Parietex Progrip, Low weight polypropylene mesh
- Keywords
- Uncomplicated primary inguinal hernias
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parietex ProgripDevice
Surgical technique:
Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
Low weight polypropylene meshDevice
Surgical technique:
Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Parietex ProGrip Receives: Device: Parietex Progrip |
| 2 | Active comparator | Low weight polypropylene mesh Receives: Device: Low weight polypropylene mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS)
Pain assessment during patient follow up after surgery using VAS score. VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home.
Measured: M3, M12 after surgery
Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS)
Surgical pain scales (=SPS) completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing. The score of evaluation will be reported in mm, specifying if pain occurs at rest, during normal activities, during exercise. The score is ranged from 0 (no pain) to 150 mm (the worst pain yu have never known).
Measured: M3, M12 after surgery
Secondary outcomes (5)
Foreign Body Sensation
Foreign body sensation using a specific questionnaire at M1, M3, M12 months after surgery. Questionnaire will be completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing.
Measured: M1, M3, M12 months after surgery
Chronic Pain Defined as Pain Lasting More Than 3 Months Using VAS Score
Chronic pain defined as pain lasting more than 3 months using VAS score. A VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home.
Measured: 3 months after surgery
Wound Complications and Hernia Recurrences
Measured: M12 after surgery
Return to Work and to Normal Daily Activities
Measured: Effective date
Other Post-operative Complications
Measured: M12 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startOct 2008
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hernia, InguinalStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 603 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827944
- Sponsor's protocol ID
- SC 0607/1
- Status last verified
- Nov 2016
- First submitted
- 22 Jan 2009
- Last updated
- 17 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sanders DL, Nienhuijs S, Ziprin P, Miserez M, Gingell-Littlejohn M, Smeds S. Randomized clinical trial comparing self-gripping mesh with suture fixation of lightweight polypropylene mesh in open inguinal hernia repair. Br J Surg. 2014 Oct;101(11):1373-82; discussion 1382. doi: 10.1002/bjs.9598. Epub 2014 Aug 21.
PubMed 25146918
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProGrip Mesh Repair Versus Lichtenstein Mesh Repair: a Comparative Randomized Study in Primary Inguinal Hernia
- ClinicalTrials.gov ID
- NCT00827944
- Acronym / sponsor ID
- SC 0607/1
- Conditions
- Hernia, Inguinal
- Keywords
- Uncomplicated primary inguinal hernias
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 603 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 23 Jan 2009 (estimated)
- Results
- Posted 17 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to evaluate pain and disabling complications inducing social consequences in primary inguinal hernia ProGrip mesh repair compared to Lichtenstein repair with lightweight polypropylene mesh.
Detailed description
- Patients in ProGrip group will be treated with self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation.
- Patients in Lichtenstein group will be treated with lightweight Polypropylene meshes requiring fixation by sutures.
- Study participation will start at signature of informed consent and each patient will be assessed before surgery. A close follow-up will be performed: 7 days (questionnaires and phone call), 1 month (clinical visit), 3 months (questionnaires and phone call), and final evaluation at 12 months (clinical visit) after surgery, which will end the participation to the study.
- 600 adult males divided in 2 groups requiring primary uncomplicated elective inguinal hernia mesh repair will be included in the study. Patients will be stratified by center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Parietex ProgripParietex ProGrip |
| 2 | Active comparator | Device: Low weight polypropylene meshLow weight polypropylene mesh |
Who may qualify
- Ages
- 31 to 74 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All male patients at participating centers with a primary, uncomplicated inguinal hernia.
- Collar of the defect ≤ 4 cm
- Signed informed consent
- Bilateral inguinal hernia
- Recurrence
Key exclusion criteria (2 listed)
- 30 years ≥ Age ≥ 75 years
- Emergency procedure
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 |
|---|---|---|
| Parietex ProgripSurgical technique: Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation. | Device | 1 |
| Low weight polypropylene meshSurgical technique: Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures | Device | 2 |
Primary outcome
Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS)
Time frame: M3, M12 after surgery
Pain assessment during patient follow up after surgery using VAS score. VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home.
Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS)
Time frame: M3, M12 after surgery
Surgical pain scales (=SPS) completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing. The score of evaluation will be reported in mm, specifying if pain occurs at rest, during normal activities, during exercise. The score is ranged from 0 (no pain) to 150 mm (the worst pain yu have never known).
5 secondary outcomes
Foreign Body Sensation
Time frame: M1, M3, M12 months after surgery
Chronic Pain Defined as Pain Lasting More Than 3 Months Using VAS Score
Time frame: 3 months after surgery
Wound Complications and Hernia Recurrences
Time frame: M12 after surgery
Return to Work and to Normal Daily Activities
Time frame: Effective date
Other Post-operative Complications
Time frame: M12 after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25146918Sanders DL, Nienhuijs S, Ziprin P, Miserez M, Gingell-Littlejohn M, Smeds S. Randomized clinical trial comparing self-gripping mesh with suture fixation of lightweight polypropylene mesh in open inguinal hernia repair. Br J Surg. 2014 Oct;101(11):1373-82; discussion 1382. doi: 10.1002/bjs.9598. Epub 2014 Aug 21.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Parietex Progrip and Low weight polypropylene mesh in people with Hernia, Inguinal, run by Medtronic - MITG at 9 sites in 5 countries.
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 5 inclusion and 2 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 17 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom, Germany, Sweden, Belgium, Netherlands. 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.
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?
Yes. Results are posted in the registry (first posted 17 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS) (time frame: M3, M12 after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00827944, which also lists 1 linked publication.
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 17 Nov 2016.