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

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2016 by be Medical
Information provided by (Responsible Party):
be Medical Identifier:
First received: August 17, 2012
Last updated: June 7, 2016
Last verified: June 2016
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 ]
    Prevalence of postoperative pain evaluated by patient self-assessment using a visual analog scale.

Secondary Outcome Measures:
  • Intraoperative complications [ Time Frame: 1 day ]
    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 ]
    Local numbness, hematoma, seroma, wound infection, mesh infection, hernia recurrence.

  • Analgesic intake [ Time Frame: Discharge, 5 weeks ]
    Intake of analgesics.

  • Quality of life (QOL) [ Time Frame: Preoperative, 5 weeks, 1 year ]
    QOL assessed by EQ-5D questionnaire.

  • Freedom from hernia-related reinterventions [ Time Frame: 1 year ]
    Reinterventions at 1 year after index-procedure assessed by means of a questionnaire.

  • Late complications [ Time Frame: 1 year ]
    Local numbness, groin discomfort, hernia recurrence, sexual dysfunction

Estimated Enrollment: 500
Study Start Date: August 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Responsible Party: be Medical Identifier: NCT01669837     History of Changes
Other Study ID Numbers: BM-IFA-06
Study First Received: August 17, 2012
Last Updated: June 7, 2016

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 September 21, 2017