Inguinal HerniaPhase 4GRIP-MENCT00820131
Chronic Pain After Inguinal Hernia Repair
A Phase 4 study testing selfgrip mesh and lightweight mesh with suture fixation in people with Inguinal Hernia and Chronic Pain, run by Medical University of Vienna at 7 sites in Austria.
Trial summary
Chronic pain after inguinal hernia repair has become a major concern. Although tension-free Lichtenstein technique is used and new lightweight meshes have been developed, still up to 40 % of patients complain of some kind of pain even one year after surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Inguinal Hernia, Chronic Pain
- What is being tested?
- selfgrip mesh and lightweight mesh with suture fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 7 sitesAustria
- Study dates
- Jan 2008to Dec 2014
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary unilateral inguinal hernia
- 18 years and older
Who cannot join
- bilateral hernia
- recurrent hernia
- incarcerated hernia
- malignant disease within the last 5 years
- not able to understand the questionaire
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Austria7 sites
LKH Feldkirch, Dept. of Surgery
Feldkirch
Hospital Barmherzige Schwestern
Linz
LK Weinviertel Mistelbach, Surgical Department
Mistelbach
KH Göttlicher Heiland
Vienna, 1170
KFJ Hospital, Dept. of Surgery
Vienna
Medical University of Vienna, Dept. of Surgery
Vienna
KH Wiener Neustadt, Surgical Department
Wiener Neustadt
About this study
Official title: A Multicenter Prospective Randomized Trial on Chronic Pain After Inguinal Hernia Repair Using a Selfgrip-mesh
Chronic pain after inguinal hernia repair has become a major concern. Although tension-free Lichtenstein technique is used and new lightweight meshes have been developed, still up to 40 % of patients complain of some kind of pain even one year after surgery. The necessity of mesh-fixation using sutures, could be causative. However, current data do not provide evidence whether suture fixation in Lichtenstein repair might be the reason for chronic postoperative pain.
A newly developed selfgrip-mesh enables sutureless fixation of the mesh in open inguinal hernia repair. Hereby a polypropylene mesh is combined with a resorbable polylactic-acid gripping system. Thereby the rate of chronic postoperative pain could be decreased.
Read more
Two techniques of inguinal hernia repair will be evaluated:
- open anterior mesh repair using conventional Lichtenstein technique (sutures for mesh-fixation)
- open anterior mesh repair using a selfgrip mesh (polylactic-acid gripping system for mesh fixation)
Postoperative pain will be evaluated by visual analog scale and Mc Gill pain questionaire at the 10th day, as well as 3 and 15 months postoperatively.
- Conditions
- Inguinal Hernia, Chronic Pain
- Being tested
- selfgrip mesh, lightweight mesh with suture fixation
- Medical subject headings
- Hernia, Inguinal, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selfgrip meshProcedure or surgery
inguinal hernia repair using a selfgrip mesh
lightweight mesh with suture fixationProcedure or surgery
inguinal hernia repair using a lightweight mesh with suture fixation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Procedure: selfgrip mesh |
| 2 | Active comparator | Not described Receives: Procedure: lightweight mesh with suture fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
chronic pain
Measured: 3 months, 15 months
Secondary outcomes (3)
morbidity
Measured: 3 months, 15 months
recurrence rate
Measured: 3 months and 15 months
quality of life
Measured: 3 months and 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startJan 2008
- Primary completionJan 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Gerhard Prager, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820131
- Sponsor's protocol ID
- EK MUW 613/2007
- Acronym
- GRIP-ME
- Status last verified
- Jan 2009
- First submitted
- 8 Jan 2009
- Last updated
- 9 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Randomized Trial on Chronic Pain After Inguinal Hernia Repair Using a Selfgrip-mesh
- ClinicalTrials.gov ID
- NCT00820131
- Acronym / sponsor ID
- GRIP-ME / EK MUW 613/2007
- Conditions
- Inguinal Hernia, Chronic Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Jan 2009 (estimated)
- 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.
Chronic pain after inguinal hernia repair has become a major concern. Although tension-free Lichtenstein technique is used and new lightweight meshes have been developed, still up to 40 % of patients complain of some kind of pain even one year after surgery. The necessity of mesh-fixation using sutures, could be causative. However, current data do not provide evidence whether suture fixation in Lichtenstein repair might be the reason for chronic postoperative pain.
A newly developed selfgrip-mesh enables sutureless fixation of the mesh in open inguinal hernia repair. Hereby a polypropylene mesh is combined with a resorbable polylactic-acid gripping system. Thereby the rate of chronic postoperative pain could be decreased.
Two techniques of inguinal hernia repair will be evaluated:
- open anterior mesh repair using conventional Lichtenstein technique (sutures for mesh-fixation)
- open anterior mesh repair using a selfgrip mesh (polylactic-acid gripping system for mesh fixation)
Postoperative pain will be evaluated by visual analog scale and Mc Gill pain questionaire at the 10th day, as well as 3 and 15 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: selfgrip mesh |
| 2 | Active comparator | Procedure: lightweight mesh with suture fixation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- primary unilateral inguinal hernia
- 18 years and older
Key exclusion criteria (5 listed)
- bilateral hernia
- recurrent hernia
- incarcerated hernia
- malignant disease within the last 5 years
- not able to understand the questionaire
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 |
|---|---|---|
| selfgrip meshinguinal hernia repair using a selfgrip mesh | Procedure or surgery | 1 |
| lightweight mesh with suture fixationinguinal hernia repair using a lightweight mesh with suture fixation | Procedure or surgery | 2 |
Primary outcome
chronic pain
Time frame: 3 months, 15 months
3 secondary outcomes
morbidity
Time frame: 3 months, 15 months
recurrence rate
Time frame: 3 months and 15 months
quality of life
Time frame: 3 months and 15 months
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 9 Dec 2014.
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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.
Gerhard Prager, MD principal investigator
Medical University of Vienna
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing selfgrip mesh and lightweight mesh with suture fixation in people with Inguinal Hernia and Chronic Pain, run by Medical University of Vienna at 7 sites in Austria.
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 5 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 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Austria. 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?
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?
chronic pain (time frame: 3 months, 15 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 9 Dec 2014.