An Efficiency/Safety Study of Surgical Tissue Glue to Treat Inguinal Hernias

This study is currently recruiting participants.
Verified March 2013 by be Medical
Information provided by (Responsible Party):
be Medical Identifier:
First received: August 17, 2012
Last updated: March 20, 2013
Last verified: March 2013

Prospective, multicenter, observational registry to collect data of laparoscopic inguinal hernia repair using surgical tissue glue fixation. The objective is to determine the prevalence of chronic pain at 1 year.

Condition Intervention
Inguinal Hernia
Device: Mesh fixation with surgical tissue glue

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cyanoacrylate Fixation for Laparoscopic Repair of Inguinal Hernias: a Prospective, Multicenter Registry

Resource links provided by NLM:

Further study details as provided by be Medical:

Primary Outcome Measures:
  • Postoperative pain [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    Prevalence of postoperative pain evaluated by patient self-assessment using a visual analog scale.

Secondary Outcome Measures:
  • Intraoperative complications [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    Complications such as bowel injury, major bleeding, complications due to anesthesia, nerve damage, lesion of vas deferens.

  • Postoperative complications [ Time Frame: Up to 30 days after index-procedure ] [ Designated as safety issue: Yes ]
    Local numbness, hematoma, seroma, wound infection, mesh infection, hernia recurrence.

  • Analgesic intake [ Time Frame: Discharge, 5 weeks ] [ Designated as safety issue: No ]
    Intake of analgesics.

  • Quality of life (QOL) [ Time Frame: Preoperative, 5 weeks, 1 year ] [ Designated as safety issue: No ]
    QOL assessed by EQ-5D questionnaire.

  • Freedom from hernia-related reinterventions [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Reinterventions at 1 year after index-procedure assessed by means of a questionnaire.

  • Late complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Local numbness, groin discomfort, hernia recurrence, sexual dysfunction

Estimated Enrollment: 500
Study Start Date: August 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patient group
Administration of surgical tissue glue.
Device: Mesh fixation with surgical tissue glue
Laparoscopic inguinal hernia repair using surgical tissue glue for mesh fixation


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with a primary inguinal hernia


Inclusion Criteria:

  • Patient is older than 18 years.
  • Written informed consent is obtained from patient.
  • Patient is able to complete the EQ-5D questionnaire.
  • Patient has a primary unilateral or primary bilateral inguinal hernia- Mesh fixation is established with solely surgical tissue glue (Ifbond™).

Exclusion Criteria:

  • Patient has a recurrent inguinal hernia.
  • Patient is treated using the Lichtenstein technique.
  • Mesh fixation with sutures, tacks, absorbable tacks or clips.
  • Patient is allergic to components of surgical tissue glue (Ifbond™).
  • Patient has a life expectancy of less than 1 year.
  Contacts and Locations
Please refer to this study by its identifier: NCT01669837

Contact: Kurt Van der Speeten, MD 003289325050

Ziekenhuis Oost-Limburg Recruiting
Genk, Limburg, Belgium, 3600
Contact: Kurt Van der Speeten, MD    003289325050   
Sponsors and Collaborators
be Medical
Principal Investigator: Kurt Van der Speeten, MD Ziekenhuis Oost-Limburg
  More Information

No publications provided

Responsible Party: be Medical Identifier: NCT01669837     History of Changes
Other Study ID Numbers: BM-IFA-06
Study First Received: August 17, 2012
Last Updated: March 20, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by be Medical:
Inguinal hernia
Surgical tissue glue

Additional relevant MeSH terms:
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal processed this record on April 17, 2014