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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by be Medical
Information provided by (Responsible Party):
be Medical Identifier:
First received: August 17, 2012
Last updated: July 15, 2015
Last verified: July 2015
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 15, 2015
Health Authority: Belgium: Ethics Committee

Keywords provided by be Medical:
Inguinal hernia
Surgical tissue glue

Additional relevant MeSH terms:
Hernia, Inguinal
Hernia, Abdominal
Pathological Conditions, Anatomical processed this record on December 01, 2015