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

This study is currently recruiting participants.
Verified March 2013 by be Medical
Sponsor:
Information provided by (Responsible Party):
be Medical
ClinicalTrials.gov Identifier:
NCT01669837
First received: August 17, 2012
Last updated: March 20, 2013
Last verified: March 2013
History of Changes
  Purpose

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:

MedlinePlus related topics: Hernia
U.S. FDA Resources

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

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT01669837

Contacts
Contact: Kurt Van der Speeten, MD 003289325050 kurt.vanderspeeten@zol.be

Locations
Belgium
Ziekenhuis Oost-Limburg Recruiting
Genk, Limburg, Belgium, 3600
Contact: Kurt Van der Speeten, MD     003289325050     kurt.vanderspeeten@zol.be    
Sponsors and Collaborators
be Medical
Investigators
Principal Investigator: Kurt Van der Speeten, MD Ziekenhuis Oost-Limburg
  More Information

No publications provided

Responsible Party: be Medical
ClinicalTrials.gov 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
Laparoscopy
Surgical tissue glue

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on May 23, 2013