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

This study is currently recruiting participants.
Verified November 2017 by Duomed
Sponsor:
ClinicalTrials.gov Identifier:
NCT01669837
First Posted: August 21, 2012
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Duomed
  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:


Further study details as provided by Duomed:

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: 1000
Study Start Date: March 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: September 2019 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 Submitted: August 17, 2012
First Posted: August 21, 2012
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