Hernia, InguinalNCT01597011
Long-term Follow-up After Laparoscopic Inguinal Hernia Repair Using Tisseel for Mesh Fixation
An observational study of Hernia, Inguinal and Recurrence, run by Herlev Hospital at 1 site in Denmark.
Trial summary
In hernia repair a mesh is used to close the defect in the abdominal wall. This mesh is either secured with tissue penetrating devices (ex. staples,tacks or sutures) or fibrin glue (Tisseel/Tissucol) or left unfixated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Inguinal, Recurrence, Chronic Pain
- What is being tested?
- Fibrin Sealant and Tissue-penetrating mesh-fixation
- Type of treatment
- Surgery or procedure
- How many people
- 2,340 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2012to Sep 2014
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be enrolled based on their registration in the Danish Hernia Database. All patients in the database who have undergone laparoscopic inguinal hernia repair from January 2009 to September 2012 will be included.
Who may be able to join
- inguinal hernia repair from January 2009-September 2012
Who cannot join
- Patients lost to follow-up
Trial locations and contacts
1 site in 1 country.
About this study
In hernia repair a mesh is used to close the defect in the abdominal wall. This mesh is either secured with tissue penetrating devices (ex. staples,tacks or sutures) or fibrin glue (Tisseel/Tissucol) or left unfixated.
The investigators believe, and previous studies indicate, that the use of fibrin glue greatly reduces the amount of postoperative complications (ex. chronic pain, impaired ejaculation in men or recurrence of the hernia)when compared with the use of tacks or staples.
The aim of this study is to compare the recurrence rates and amount of postoperative complications in patients who have had inguinal hernia repair with fibrin glue and in patients who have had inguinal hernia repair with tacks, staples or sutures.
Read the detailed description
The study will use prospectively collected data from the Danish Hernia Database to find the patients. The patients will be contacted using a questionnaire.
- Conditions
- Hernia, Inguinal, Recurrence, Chronic Pain
- Being tested
- Fibrin Sealant, Tissue-penetrating mesh-fixation
- Keywords
- Hernia, Inguinal, Hernia repair, Fibrin Tissue Adhesive, Tisseel, Tissucol, Recurrence, Chronic Pain, Dysejaculation
- Medical subject headings
- Hernia, Inguinal, Recurrence, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin SealantProcedure or surgery
Also called Tisseel, Fibrin glue
Use of fibrin sealant for mesh fixation in laparoscopic inguinal hernia repair,
Tissue-penetrating mesh-fixationProcedure or surgery
Also called Protacks, Hernia stapler
Use of tacks, staples or sutures for mesh fixation in inguinal hernia repair
| Study group | Role | What they receive |
|---|---|---|
| Fibrin sealant group | Patients who have undergone laparoscopic inguinal hernia repair with fibrin sealant for mesh fixation Receives: Procedure: Fibrin Sealant | |
| Tissue-penetrating fixation group | Patients who have undergone laparoscopic inguinal hernia repair with the use of tacks, staples or sutures for mesh fixation Receives: Procedure: Tissue-penetrating mesh-fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic pain
Reported pain (questionnaire) from one year after procedure
Measured: within period from one year after procedure until follow-up
Secondary outcomes (2)
Recurrence
Reherniation at repaired site. Defined as a clinically observable hernia or reoperation prior to follow-up
Measured: within period from procedure to follow-up
dysejaculation
Reported ejaculatory dysfunction in male patients
Measured: Debut within period from procedure to follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Qwist Fenger, Herlev Hospital
- Investigators
- Neel M Helvind, Researcher, Principal investigator, Herlev HospitalJacob Rosenberg, professor, Study chair, Herlev HospitalAndreas Q Fenger, Researcher, Principal investigator, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597011
- Sponsor's protocol ID
- BS12-000733
- Status last verified
- Mar 2015
- First submitted
- 9 May 2012
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up After Laparoscopic Inguinal Hernia Repair Using Tisseel for Mesh Fixation
- ClinicalTrials.gov ID
- NCT01597011
- Acronym / sponsor ID
- BS12-000733
- Conditions
- Hernia, Inguinal, Recurrence, Chronic Pain
- Keywords
- Hernia, Inguinal, Hernia repair, Fibrin Tissue Adhesive, Tisseel, Tissucol, Recurrence, Chronic Pain, Dysejaculation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,340 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 11 May 2012 (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.
In hernia repair a mesh is used to close the defect in the abdominal wall. This mesh is either secured with tissue penetrating devices (ex. staples,tacks or sutures) or fibrin glue (Tisseel/Tissucol) or left unfixated.
The investigators believe, and previous studies indicate, that the use of fibrin glue greatly reduces the amount of postoperative complications (ex. chronic pain, impaired ejaculation in men or recurrence of the hernia)when compared with the use of tacks or staples.
The aim of this study is to compare the recurrence rates and amount of postoperative complications in patients who have had inguinal hernia repair with fibrin glue and in patients who have had inguinal hernia repair with tacks, staples or sutures.
Detailed description
The study will use prospectively collected data from the Danish Hernia Database to find the patients. The patients will be contacted using a questionnaire.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibrin sealant group | – | Procedure: Fibrin SealantPatients who have undergone laparoscopic inguinal hernia repair with fibrin sealant for mesh fixation |
| Tissue-penetrating fixation group | – | Procedure: Tissue-penetrating mesh-fixationPatients who have undergone laparoscopic inguinal hernia repair with the use of tacks, staples or sutures for mesh fixation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be enrolled based on their registration in the Danish Hernia Database. All patients in the database who have undergone laparoscopic inguinal hernia repair from January 2009 to September 2012 will be included.
Key inclusion criteria (1 listed)
- inguinal hernia repair from January 2009-September 2012
Key exclusion criteria (1 listed)
- Patients lost to follow-up
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 |
|---|---|---|
| Fibrin SealantAlso: Tisseel, Fibrin glueUse of fibrin sealant for mesh fixation in laparoscopic inguinal hernia repair, | Procedure or surgery | Fibrin sealant group |
| Tissue-penetrating mesh-fixationAlso: Protacks, Hernia staplerUse of tacks, staples or sutures for mesh fixation in inguinal hernia repair | Procedure or surgery | Tissue-penetrating fixation group |
Primary outcome
Chronic pain
Time frame: within period from one year after procedure until follow-up
Reported pain (questionnaire) from one year after procedure
2 secondary outcomes
Recurrence
Time frame: within period from procedure to follow-up
dysejaculation
Time frame: Debut within period from procedure to follow-up
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 18 Mar 2015.
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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.
Neel M Helvind, Researcher principal investigator
Herlev Hospital
Jacob Rosenberg, professor study chair
Herlev Hospital
Andreas Q Fenger, Researcher principal investigator
Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia, Inguinal and Recurrence, run by Herlev 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 18 Mar 2015. 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?
Chronic pain (time frame: within period from one year after procedure until follow-up). 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 18 Mar 2015.