Clinical trial NCT00306839: Efficacy Study of Tissucol/Tisseel Fibrin Sealant to Treat Inguinal Hernia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inguinal Hernia
Keywords: Tissucol
Tisseel
Lichtenstein
hernia
inguinal
Lead sponsor: University of Milan
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
name: Pr Giampiero CAMPANELLI
First posted: 2006-03-24
Enrollment: 325
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Combined endpoint evaluating incidence of disabling complications:chronic pain and/or numbness and/or groin discomfort assessed 1 year after surgery.
Secondary outcomes:
measure: Recurrence
measure: Overall wound-healing complication rate (bleeding complications, bruising, seroma, wound infection, mesh infection)
measure: Early postoperative pain at W1 and M1
measure: Mid-term postoperative pain at M6
measure: Incidence of patients without pain at M1, M6 and M12
measure: Use of analgesic drugs
measure: Patient's satisfaction
measure: Safety (incidence of adverse events)
measure: Quality of Life assessed by SF12 pre-operatively or at D-1, M1, M6 and M12
measure: Hospital stay (hour or Days) and time to return to normal activities
measure: A subgroup analysis will be done for patients receiving pre-operatively aspirin or LMW sub-cutaneous heparin.
measure: The study will be blinded for the patient and for the physician evaluating the pain.
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Gasthuisberg University Hospitals KUL
city: Hellerup
country: Denmark
facility: Copenhagen university hospital, Gentofte
city: Bondy
country: France
facility: Hôpital Jean Verdier
city: Mainz
country: Germany
facility: St. Hildegardis-Krankenhaus
city: Madrid
country: Spain
facility: Clinica Nuestra Senora del Rosario
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
Study officials:
name: CAMPANELLI Giampiero, Professor
role: STUDY_CHAIR
References:
citation: 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.