Inguinal HerniaDangripNCT00815698
Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair
A study testing suture and no suture in people with Inguinal Hernia, run by Jacob Rosenberg at 5 sites in Denmark.
Trial summary
The investigators want to evaluate the effect of suturing the mesh versus using a self-adhesive mesh for Lichtenstein hernia repair. Effect parameters include chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- suture and no suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 5 sitesDenmark
- Study dates
- Dec 2008to Sep 2011
- Phase
- Interventional
- 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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy males 18-80 years
- Primary inguinal unilateral hernia
Who cannot join
- Recurrent hernia
- Bilateral, scrotal or femoral hernia
- BMI above 35
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Bispebjerg Hospital
Copenhagen, Copenhaven, 2400
Frederikshavn Hospital
Frederikshavn, Frederikshavn, 9900
Gentofte Hospital
Gentofte Municipality, Hellerup, 2900
Nyborg Hospital
Nyborg, Svendborg, 5700
Randers Hospital
Randers, Randers, 8930
About this study
Official title: Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair, a Prospective Controlled Randomized Trial
The investigators want to evaluate the effect of suturing the mesh versus using a self-adhesive mesh for Lichtenstein hernia repair. Effect parameters include chronic pain.
Read the detailed description
Pain is a frequent problem after open inguinal hernia repair. The most frequent operative technique for inguinal hernia repair in adults is the Lichtenstein mesh repair, where a polypropylene mesh is sutured to the tissue in the inguinal region. We therefore want to evaluate the effect of suture for mesh fixation on the occurrence of chronic pain 12 months after operation.
- Conditions
- Inguinal Hernia
- Being tested
- suture, no suture
- Keywords
- pain
- Medical subject headings
- Hernia, Inguinal, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sutureProcedure or surgery
Also called Prolene and Vicryl sutures
suture for mesh fixation
no sutureProcedure or surgery
Also called Progrip mesh
no suture for mesh fixation, because we use a self-adhesive mesh
| Study group | Role | What they receive |
|---|---|---|
| no suture | Active comparator | self-adhesive mesh, i.e. no suture for mesh fixation Receives: Procedure: no suture |
| Suture | Experimental | Suture for mesh fixation Receives: Procedure: suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain, Numbness and Discomfort in the Groin
The primary endpoint was a combined measure that evaluated the prevalence of symptoms considered moderate or severe. These symptoms included moderate to severe chronic pain and/or numbness and/or groin discomfort at the 12-month visit.
Measured: 12 months after surgery
Secondary outcomes (1)
Recurrence
recurrence means recurrence of the hernia defined as a new lump in the inguinal region diagnosed by a surgeon to be a new inguinal hernia.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionApr 2011
- Study completionSep 2011
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 (2)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacob Rosenberg
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital, University Hospital, Gentofte, Copenhagen, Frederikshavn Hospital, Nyborg Hospital
- Responsible party
- Sponsor-investigator, Jacob Rosenberg, Herlev Hospital
- Investigators
- Jacob Rosenberg, MD, DSc, Principal investigator, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815698
- Sponsor's protocol ID
- CPODenmark001
- Acronym
- Dangrip
- Status last verified
- Feb 2016
- First submitted
- 29 Dec 2008
- Last updated
- 23 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Jorgensen LN, Sommer T, Assaadzadeh S, Strand L, Dorfelt A, Hensler M, Rosenberg J; Danish Multicentre DANGRIP Study Group. Randomized clinical trial of self-gripping mesh versus sutured mesh for Lichtenstein hernia repair. Br J Surg. 2013 Mar;100(4):474-81. doi: 10.1002/bjs.9006. Epub 2012 Nov 30.
PubMed 23203909Rosenberg J, Henriksen NA, Jorgensen LN. Multicenter data acquisition made easy. Trials. 2010 Apr 30;11:49. doi: 10.1186/1745-6215-11-49.
PubMed 20433715
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair, a Prospective Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT00815698
- Acronym / sponsor ID
- Dangrip / CPODenmark001
- Conditions
- Inguinal Hernia
- Keywords
- pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Jacob RosenbergUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital, University Hospital, Gentofte, Copenhagen, Frederikshavn Hospital, Nyborg Hospital
- Study start
- Dec 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 30 Dec 2008 (estimated)
- Results
- Posted 23 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators want to evaluate the effect of suturing the mesh versus using a self-adhesive mesh for Lichtenstein hernia repair. Effect parameters include chronic pain.
Detailed description
Pain is a frequent problem after open inguinal hernia repair. The most frequent operative technique for inguinal hernia repair in adults is the Lichtenstein mesh repair, where a polypropylene mesh is sutured to the tissue in the inguinal region. We therefore want to evaluate the effect of suture for mesh fixation on the occurrence of chronic pain 12 months after operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no suture | Active comparator | Procedure: no sutureself-adhesive mesh, i.e. no suture for mesh fixation |
| Suture | Experimental | Procedure: sutureSuture for mesh fixation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy males 18-80 years
- Primary inguinal unilateral hernia
Key exclusion criteria (3 listed)
- Recurrent hernia
- Bilateral, scrotal or femoral hernia
- BMI above 35
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 |
|---|---|---|
| sutureAlso: Prolene and Vicryl suturessuture for mesh fixation | Procedure or surgery | Suture |
| no sutureAlso: Progrip meshno suture for mesh fixation, because we use a self-adhesive mesh | Procedure or surgery | no suture |
Primary outcome
Pain, Numbness and Discomfort in the Groin
Time frame: 12 months after surgery
The primary endpoint was a combined measure that evaluated the prevalence of symptoms considered moderate or severe. These symptoms included moderate to severe chronic pain and/or numbness and/or groin discomfort at the 12-month visit.
1 secondary outcome
Recurrence
Time frame: 12 months after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23203909Jorgensen LN, Sommer T, Assaadzadeh S, Strand L, Dorfelt A, Hensler M, Rosenberg J; Danish Multicentre DANGRIP Study Group. Randomized clinical trial of self-gripping mesh versus sutured mesh for Lichtenstein hernia repair. Br J Surg. 2013 Mar;100(4):474-81. doi: 10.1002/bjs.9006. Epub 2012 Nov 30.
- Derived from this study: PubMed 20433715Rosenberg J, Henriksen NA, Jorgensen LN. Multicenter data acquisition made easy. Trials. 2010 Apr 30;11:49. doi: 10.1186/1745-6215-11-49.
- 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.
Jacob Rosenberg, MD, DSc principal investigator
Herlev Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing suture and no suture in people with Inguinal Hernia, run by Jacob Rosenberg at 5 sites 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 2 inclusion and 3 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 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 23 Mar 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, Numbness and Discomfort in the Groin (time frame: 12 months after surgery). 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 NCT00815698, which also lists 2 linked publications.
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 23 Mar 2016.