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Efficacy Study of Tissucol/Tisseel Fibrin Sealant to Treat Inguinal Hernia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00306839
Recruitment Status : Completed
First Posted : March 24, 2006
Last Update Posted : February 13, 2009
Sponsor:
Collaborators:
Baxter Healthcare Corporation
Pr Giampiero CAMPANELLI
Information provided by:
University of Milan

Brief 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.

Condition or disease Intervention/treatment Phase
Inguinal Hernia Procedure: standardized Lichtenstein technique Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : February 2006
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
1
Tissel group
Procedure: standardized Lichtenstein technique
2
Suture group
Procedure: standardized Lichtenstein technique



Primary Outcome Measures :
  1. Combined endpoint evaluating incidence of disabling complications:chronic pain and/or numbness and/or groin discomfort assessed 1 year after surgery.

Secondary Outcome Measures :
  1. Recurrence
  2. Overall wound-healing complication rate (bleeding complications, bruising, seroma, wound infection, mesh infection)
  3. Early postoperative pain at W1 and M1
  4. Mid-term postoperative pain at M6
  5. Incidence of patients without pain at M1, M6 and M12
  6. Use of analgesic drugs
  7. Patient's satisfaction
  8. Safety (incidence of adverse events)
  9. Quality of Life assessed by SF12 pre-operatively or at D-1, M1, M6 and M12
  10. Hospital stay (hour or Days) and time to return to normal activities
  11. A subgroup analysis will be done for patients receiving pre-operatively aspirin or LMW sub-cutaneous heparin.
  12. The study will be blinded for the patient and for the physician evaluating the pain.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00306839


Locations
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Belgium
Gasthuisberg University Hospitals KUL
Leuven, Belgium, 3000
Denmark
Copenhagen university hospital, Gentofte
Hellerup, Denmark, 2900
France
Hôpital Jean Verdier
Bondy, France, 93143
Germany
St. Hildegardis-Krankenhaus
Mainz, Germany, 55131
Spain
Clinica Nuestra Senora del Rosario
Madrid, Spain, 28006
United Kingdom
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Sponsors and Collaborators
University of Milan
Baxter Healthcare Corporation
Pr Giampiero CAMPANELLI
Investigators
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Study Chair: CAMPANELLI Giampiero, Professor
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00306839    
Other Study ID Numbers: TIMELI 001
First Posted: March 24, 2006    Key Record Dates
Last Update Posted: February 13, 2009
Last Verified: February 2009
Keywords provided by University of Milan:
Tissucol
Tisseel
Lichtenstein
hernia
inguinal
Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal