NCT00306839

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
325

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2006

Typical duration for phase_4

Geographic Reach
6 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2006

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

February 13, 2009

Status Verified

February 1, 2009

First QC Date

March 22, 2006

Last Update Submit

February 12, 2009

Conditions

Inguinal Hernia

Keywords

TissucolTisseelLichtensteinherniainguinal

Outcome Measures

Primary Outcomes (1)

  • 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

  • +7 more secondary outcomes

Study Arms (2)

1

OTHER

Tissel group

Procedure: standardized Lichtenstein technique

2

OTHER

Suture group

Procedure: standardized Lichtenstein technique

Interventions

standardized Lichtenstein techniquePROCEDURE
12

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Gasthuisberg University Hospitals KUL

Leuven, 3000, Belgium

Location

Copenhagen university hospital, Gentofte

Hellerup, 2900, Denmark

Location

Hôpital Jean Verdier

Bondy, 93143, France

Location

St. Hildegardis-Krankenhaus

Mainz, 55131, Germany

Location

Clinica Nuestra Senora del Rosario

Madrid, 28006, Spain

Location

Derriford Hospital

Plymouth, PL6 8DH, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 22395092DERIVED

MeSH Terms

Conditions

Hernia, InguinalHernia

Condition Hierarchy (Ancestors)

Hernia, AbdominalPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • CAMPANELLI Giampiero, Professor

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 22, 2006

First Posted

March 24, 2006

Study Start

February 1, 2006

Study Completion

May 1, 2008

Last Updated

February 13, 2009

Record last verified: 2009-02

Locations

DE(1)GB(1)FR(1)DK(1)BE(1)ES(1)