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

Inguinal Hernia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00306839
• Other study ID #: TIMELI 001
• Status: Completed
• Phase: Phase 4
• First received: March 22, 2006
• Last updated: February 12, 2009
• Start date: February 2006
• Est. completion date: May 2008

Study information

• Verified date: February 2009
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyItaly: Ethics CommitteeFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Paul-Ehrlich-InstitutSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• standardized Lichtenstein technique

Locations

Country	Name	City	State
Belgium	Gasthuisberg University Hospitals KUL	Leuven
Denmark	Copenhagen university hospital, Gentofte	Hellerup
France	Hôpital Jean Verdier	Bondy
Germany	St. Hildegardis-Krankenhaus	Mainz
Spain	Clinica Nuestra Senora del Rosario	Madrid
United Kingdom	Derriford Hospital	Plymouth

Sponsors (3)

Lead Sponsor	Collaborator
University of Milan	Baxter Healthcare Corporation, Pr Giampiero CAMPANELLI

Countries where clinical trial is conducted

Belgium,  Denmark,  France,  Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined endpoint evaluating incidence of disabling complications:chronic pain and/or numbness and/or groin discomfort assessed 1 year after surgery.
Secondary	Recurrence
Secondary	Overall wound-healing complication rate (bleeding complications, bruising, seroma, wound infection, mesh infection)
Secondary	Early postoperative pain at W1 and M1
Secondary	Mid-term postoperative pain at M6
Secondary	Incidence of patients without pain at M1, M6 and M12
Secondary	Use of analgesic drugs
Secondary	Patient's satisfaction
Secondary	Safety (incidence of adverse events)
Secondary	Quality of Life assessed by SF12 pre-operatively or at D-1, M1, M6 and M12
Secondary	Hospital stay (hour or Days) and time to return to normal activities
Secondary	A subgroup analysis will be done for patients receiving pre-operatively aspirin or LMW sub-cutaneous heparin.
Secondary	The study will be blinded for the patient and for the physician evaluating the pain.