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

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ClinicalTrials.gov Identifier: NCT01669837
Recruitment Status : Recruiting
First Posted : August 21, 2012
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Inguinal Hernia Device: Mesh fixation with surgical tissue glue

Study Design

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cyanoacrylate Fixation for Laparoscopic Repair of Inguinal Hernias: a Prospective, Multicenter Registry
Study Start Date : March 2012
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

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

  2. Postoperative complications [ Time Frame: Up to 30 days after index-procedure ]
    Local numbness, hematoma, seroma, wound infection, mesh infection, hernia recurrence.

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

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

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

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


Eligibility Criteria

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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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669837


Contacts
Contact: Dorien Haesen 0032470219703 dorien.haesen@archerresearch.eu
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   
Principal Investigator: Joost Vankeirsbilck, MD         
Principal Investigator: Luc Berwouts, MD         
Principal Investigator: Nele Van de Winkel, MD         
Principal Investigator: Anthony Beunis, MD         
Sponsors and Collaborators
Duomed
Investigators
Principal Investigator: Kurt Van der Speeten, MD Ziekenhuis Oost-Limburg
More Information

Responsible Party: Duomed
ClinicalTrials.gov Identifier: NCT01669837     History of Changes
Other Study ID Numbers: BM-IFA-06
First Posted: August 21, 2012    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

Keywords provided by Duomed:
Inguinal hernia
Laparoscopy
Surgical tissue glue

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