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

Sponsor

University of Milan (Other)

Overall Status

Completed

CT.gov ID

NCT00306839

Collaborator

Baxter Healthcare Corporation (Industry), Pr Giampiero CAMPANELLI (Other)

325

Enrollment

Locations

Arms

26.9

Duration (Months)

54.2

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Feb 1, 2006

Actual Study Completion Date :

May 1, 2008

Arms and Interventions

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

Arm

Intervention/Treatment

Other: 1

Tissel group

Procedure: standardized Lichtenstein technique

Other: 2

Suture group

Procedure: standardized Lichtenstein technique

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Gasthuisberg University Hospitals KUL	Leuven	Belgium	3000
2	Copenhagen university hospital, Gentofte	Hellerup	Denmark	2900
3	Hôpital Jean Verdier	Bondy	France	93143
4	St. Hildegardis-Krankenhaus	Mainz	Germany	55131
5	Clinica Nuestra Senora del Rosario	Madrid	Spain	28006
6	Derriford Hospital	Plymouth	United Kingdom	PL6 8DH