Inguinal HerniaPhase 4NCT00306839
Efficacy Study of Tissucol/Tisseel Fibrin Sealant to Treat Inguinal Hernia
A Phase 4 study testing standardized Lichtenstein technique in people with Inguinal Hernia, run by University of Milan at 6 sites in 6 countries.
Trial summary
The purpose of the study is to evaluate mid and long term postoperative pain and further disabling complications in open inguinal hernia repair by Lichtenstein technique after mesh fixation with fibrin sealant (FS), compared to mesh fixation with sutures. 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?
- standardized Lichtenstein technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Feb 2006to May 2008
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent obtained from the subject prior to participation in the study
- Active males over the age of 18 years and below 80 years
- Experiencing an uncomplicated unilateral primary inguinal hernia or experiencing an uncomplicated bilateral hernia provided that only one hernia is operated during the 12 months of study follow-up
- Subjects eligible for elective inguinal hernia repair using Lichtenstein technique.
Who cannot join
- Recurrent, scrotal, incarcerated or femoral hernias
- Hernia types L3 and M3 according the EHS classification
- BMI equal or more than 35
- Concomitant abdominal surgery
- Ongoing long term analgesic or steroid treatment
- Patients under Clopidogrel or Warfarin (can be switched to LMW sub-cutaneous heparin)
Show all 12Show fewer
- Known abuse of alcohol or drugs
- Liver cirrhosis (Child C)
- Previous treatment or Hypersensitivity to bovine aprotinin
- Known immunodeficiency
- Severely compromised physical or psychological health, that in the investigator's opinion will affect patient compliance
- Concurrently participating in another clinical trial and having received another investigational drug or device within the last 30 days
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: Prospective, Controlled, Randomized Study to Evaluate Pain and Further Disabling Complications in Patients Undergoing Lichtenstein Technique for Primary Inguinal Hernia Repair by Fixing the Mesh With Fibrin Sealant Versus Sutures
The purpose of the study is to evaluate mid and long term postoperative pain and further disabling complications in open inguinal hernia repair by Lichtenstein technique after mesh fixation with fibrin sealant (FS), compared to mesh fixation with sutures.
Read the detailed description
Subjects in the FS group will be operated by Lichtenstein technique, with mesh fixation by fibrin sealant. Subjects in control group will be operated with conventional Lichtenstein technique (mesh fixation by sutures).
Hernia repair will be performed according to standardized Lichtenstein technique, a technique for tension free hernioplasty. A Polypropylene, heavyweight, macroporous mesh will be used (8x15 cm) tailored to individual patients requirement. The different ways of mesh fixation will be randomly assigned within 24 hours before the operation. In the FS group, the two tails of the mesh will be fixed together in overlapping their edges and by surrounding the cord. The edges will be joined up to by 1 suture. No other sutures will be used. First the mesh will be put correctly in place. A small spot (0.5ml) of FS will be applied on the pubis under the mesh without spray then the remaining part (3,5ml) over the mesh on the entire surface in a thin uniform layer by spray. 2 ml Tissucol-Tisseel (4 ml of fibrin sealant) will be used per mesh. In the control group, the mesh will be fixed in a conventional manner. Nerve resection (if occurred) will be recorded; it should be avoided.
- Conditions
- Inguinal Hernia
- Being tested
- standardized Lichtenstein technique
- Keywords
- Tissucol, Tisseel, Lichtenstein, hernia, inguinal
- Medical subject headings
- Hernia, Inguinal, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized Lichtenstein techniqueProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Tissel group Receives: Procedure: standardized Lichtenstein technique |
| 2 | Other | Suture group Receives: Procedure: standardized Lichtenstein technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined endpoint evaluating incidence of disabling complications:chronic pain and/or numbness and/or groin discomfort assessed 1 year after surgery.
Secondary outcomes (12)
Recurrence
Overall wound-healing complication rate (bleeding complications, bruising, seroma, wound infection, mesh infection)
Early postoperative pain at W1 and M1
Mid-term postoperative pain at M6
Incidence of patients without pain at M1, M6 and M12
Use of analgesic drugs
Patient's satisfaction
Safety (incidence of adverse events)
Quality of Life assessed by SF12 pre-operatively or at D-1, M1, M6 and M12
Hospital stay (hour or Days) and time to return to normal activities
A subgroup analysis will be done for patients receiving pre-operatively aspirin or LMW sub-cutaneous heparin.
The study will be blinded for the patient and for the physician evaluating the pain.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2006 (estimated)
- Study startFeb 2006
- Study completionMay 2008
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.
- 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
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation, Pr Giampiero CAMPANELLI
- Investigators
- CAMPANELLI Giampiero, Professor, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306839
- Sponsor's protocol ID
- TIMELI 001
- Status last verified
- Feb 2009
- First submitted
- 22 Mar 2006
- Last updated
- 13 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Campanelli G, Pascual MH, Hoeferlin A, Rosenberg J, Champault G, Kingsnorth A, Miserez M. Randomized, controlled, blinded trial of Tisseel/Tissucol for mesh fixation in patients undergoing Lichtenstein technique for primary inguinal hernia repair: results of the TIMELI trial. Ann Surg. 2012 Apr;255(4):650-7. doi: 10.1097/SLA.0b013e31824b32bf.
PubMed 22395092
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Controlled, Randomized Study to Evaluate Pain and Further Disabling Complications in Patients Undergoing Lichtenstein Technique for Primary Inguinal Hernia Repair by Fixing the Mesh With Fibrin Sealant Versus Sutures
- ClinicalTrials.gov ID
- NCT00306839
- Acronym / sponsor ID
- TIMELI 001
- Conditions
- Inguinal Hernia
- Keywords
- Tissucol, Tisseel, Lichtenstein, hernia, inguinal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation, Pr Giampiero CAMPANELLI
- Study start
- Feb 2006
- Study completion
- May 2008 (actual)
- First posted
- 24 Mar 2006 (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.
The purpose of the study is to evaluate mid and long term postoperative pain and further disabling complications in open inguinal hernia repair by Lichtenstein technique after mesh fixation with fibrin sealant (FS), compared to mesh fixation with sutures.
Detailed description
Subjects in the FS group will be operated by Lichtenstein technique, with mesh fixation by fibrin sealant. Subjects in control group will be operated with conventional Lichtenstein technique (mesh fixation by sutures).
Hernia repair will be performed according to standardized Lichtenstein technique, a technique for tension free hernioplasty. A Polypropylene, heavyweight, macroporous mesh will be used (8x15 cm) tailored to individual patients requirement. The different ways of mesh fixation will be randomly assigned within 24 hours before the operation. In the FS group, the two tails of the mesh will be fixed together in overlapping their edges and by surrounding the cord. The edges will be joined up to by 1 suture. No other sutures will be used. First the mesh will be put correctly in place. A small spot (0.5ml) of FS will be applied on the pubis under the mesh without spray then the remaining part (3,5ml) over the mesh on the entire surface in a thin uniform layer by spray. 2 ml Tissucol-Tisseel (4 ml of fibrin sealant) will be used per mesh. In the control group, the mesh will be fixed in a conventional manner. Nerve resection (if occurred) will be recorded; it should be avoided.
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 | Other | Procedure: standardized Lichtenstein techniqueTissel group |
| 2 | Other | Procedure: standardized Lichtenstein techniqueSuture group |
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)
- Signed informed consent obtained from the subject prior to participation in the study
- Active males over the age of 18 years and below 80 years
- Experiencing an uncomplicated unilateral primary inguinal hernia or experiencing an uncomplicated bilateral hernia provided that only one hernia is operated during the 12 months of study follow-up
- Subjects eligible for elective inguinal hernia repair using Lichtenstein technique.
Key exclusion criteria (12 listed)
- Recurrent, scrotal, incarcerated or femoral hernias
- Hernia types L3 and M3 according the EHS classification
- BMI equal or more than 35
- Concomitant abdominal surgery
- Ongoing long term analgesic or steroid treatment
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 |
|---|---|---|
| standardized Lichtenstein technique | Procedure or surgery | 1, 2 |
Primary outcome
Combined endpoint evaluating incidence of disabling complications:chronic pain and/or numbness and/or groin discomfort assessed 1 year after surgery.
12 secondary outcomes
Recurrence
Overall wound-healing complication rate (bleeding complications, bruising, seroma, wound infection, mesh infection)
Early postoperative pain at W1 and M1
Mid-term postoperative pain at M6
Incidence of patients without pain at M1, M6 and M12
Use of analgesic drugs
Patient's satisfaction
Safety (incidence of adverse events)
Quality of Life assessed by SF12 pre-operatively or at D-1, M1, M6 and M12
Hospital stay (hour or Days) and time to return to normal activities
A subgroup analysis will be done for patients receiving pre-operatively aspirin or LMW sub-cutaneous heparin.
The study will be blinded for the patient and for the physician evaluating the pain.
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 13 Feb 2009.
- Derived from this study: PubMed 22395092Campanelli G, Pascual MH, Hoeferlin A, Rosenberg J, Champault G, Kingsnorth A, Miserez M. Randomized, controlled, blinded trial of Tisseel/Tissucol for mesh fixation in patients undergoing Lichtenstein technique for primary inguinal hernia repair: results of the TIMELI trial. Ann Surg. 2012 Apr;255(4):650-7. doi: 10.1097/SLA.0b013e31824b32bf.
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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.
CAMPANELLI Giampiero, Professor study chair
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing standardized Lichtenstein technique in people with Inguinal Hernia, run by University of Milan at 6 sites in 6 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 4 inclusion and 12 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 13 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium, Denmark, France, Germany, Spain and 1 more country. 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?
Combined endpoint evaluating incidence of disabling complications:chronic pain and/or numbness and/or groin discomfort assessed 1 year 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 NCT00306839, 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 13 Feb 2009; AzTrials last refreshed its copy on 8 Nov 2026.