Inguinal HerniaNCT01000116
Fibrin Glue Versus Tacked Fixation in Groin Hernia Repair (TAPP)
A study testing Fibrin glue and Tacks in people with Inguinal Hernia and Femoral Hernia, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
In this study the researchers want to compare fibrin glue versus tacked fixation in fixation of the mesh in laparoscopic groin hernia repair. The primary endpoints are early pain in the first 3 days postoperative days. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Inguinal Hernia, Femoral Hernia
- What is being tested?
- Fibrin glue and Tacks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2009to Feb 2012
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral groin hernia
- planned laparoscopic inguinal or femoral herniorrhaphy
- ASA I-III
- fluent Danish
Who cannot join
- converting to open operation
- low compliance
- daily use of morphine or similar drugs daily in the last month
- complications to the operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fibrin Glue Versus Tacked Fixation in Laparoscopic Groin Hernia Repair. A Randomized Double-blind Placebo-controlled Trial.
In this study the researchers want to compare fibrin glue versus tacked fixation in fixation of the mesh in laparoscopic groin hernia repair. The primary endpoints are early pain in the first 3 days postoperative days. Moreover, the researchers investigate general well-being, fatigue, seroma, haematoma, postoperative nausea and vomiting. Thirdly, they are investigating chronic pain and clinical recurrence.
- Conditions
- Inguinal Hernia, Femoral Hernia
- Being tested
- Fibrin glue, Tacks
- Keywords
- Tapp, Early pain, well-being, Seroma, Haematoma, Fibrin glue, tacks
- Medical subject headings
- Hernia, Inguinal, Hernia, Femoral, Pain, Seroma, Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin glueProcedure or surgery
Tissucol 2 ml
TacksProcedure or surgery
Protacks
| Study group | Role | What they receive |
|---|---|---|
| Fibrin glue | Active comparator | Not described Receives: Procedure: Tacks |
| Tacks | Active comparator | Not described Receives: Procedure: Fibrin glue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early pain after operation
Measured: 1 month
Secondary outcomes (6)
haematoma in groin region
Measured: day 10
seroma in groin region
Measured: day 10
fatigue
Measured: 10 days
discomfort
Measured: 6 month
Postoperative nausea and vomiting (PONV)
Measured: 10 days
Use of Analgesics at PACU
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mette Astrup Madsen, Zealand University Hospital
- Investigators
- Mette A Tolver, M.D., Principal investigator, University Hospital KoegeThue Bisgaard, M.D. DMSc, Principal investigator, University Hospital KoegePoul Juul, M.D., Principal investigator, Private Hospital HamletJacob Rosenberg, M.D. DMSc, Principal investigator, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000116
- Sponsor's protocol ID
- SJ-138
- Status last verified
- Aug 2024
- First submitted
- 16 Oct 2009
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tolver MA, Rosenberg J, Juul P, Bisgaard T. Randomized clinical trial of fibrin glue versus tacked fixation in laparoscopic groin hernia repair. Surg Endosc. 2013 Aug;27(8):2727-33. doi: 10.1007/s00464-012-2766-6. Epub 2013 Jan 26.
PubMed 23355162
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibrin Glue Versus Tacked Fixation in Laparoscopic Groin Hernia Repair. A Randomized Double-blind Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT01000116
- Acronym / sponsor ID
- SJ-138
- Conditions
- Inguinal Hernia, Femoral Hernia
- Keywords
- Tapp, Early pain, well-being, Seroma, Haematoma, Fibrin glue, tacks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 22 Oct 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.
In this study the researchers want to compare fibrin glue versus tacked fixation in fixation of the mesh in laparoscopic groin hernia repair. The primary endpoints are early pain in the first 3 days postoperative days. Moreover, the researchers investigate general well-being, fatigue, seroma, haematoma, postoperative nausea and vomiting. Thirdly, they are investigating chronic pain and clinical recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibrin glue | Active comparator | Procedure: Tacks |
| Tacks | Active comparator | Procedure: Fibrin glue |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- unilateral groin hernia
- planned laparoscopic inguinal or femoral herniorrhaphy
- ASA I-III
- fluent Danish
Key exclusion criteria (4 listed)
- converting to open operation
- low compliance
- daily use of morphine or similar drugs daily in the last month
- complications to the operation
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 glueTissucol 2 ml | Procedure or surgery | Tacks |
| TacksProtacks | Procedure or surgery | Fibrin glue |
Primary outcome
Early pain after operation
Time frame: 1 month
6 secondary outcomes
haematoma in groin region
Time frame: day 10
seroma in groin region
Time frame: day 10
fatigue
Time frame: 10 days
discomfort
Time frame: 6 month
Postoperative nausea and vomiting (PONV)
Time frame: 10 days
Use of Analgesics at PACU
Time frame: 1 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 26 Aug 2024.
- Derived from this study: PubMed 23355162Tolver MA, Rosenberg J, Juul P, Bisgaard T. Randomized clinical trial of fibrin glue versus tacked fixation in laparoscopic groin hernia repair. Surg Endosc. 2013 Aug;27(8):2727-33. doi: 10.1007/s00464-012-2766-6. Epub 2013 Jan 26.
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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.
Mette A Tolver, M.D. principal investigator
University Hospital Koege
Thue Bisgaard, M.D. DMSc principal investigator
University Hospital Koege
Poul Juul, M.D. principal investigator
Private Hospital Hamlet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibrin glue and Tacks in people with Inguinal Hernia and Femoral Hernia, 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 4 inclusion and 4 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 26 Aug 2024. 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?
Early pain after operation (time frame: 1 month). 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 NCT01000116, 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 26 Aug 2024.