NCT01669837

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2012

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

7.8 years

First QC Date

August 17, 2012

Last Update Submit

June 18, 2020

Conditions

Inguinal Hernia

Keywords

Inguinal herniaLaparoscopySurgical tissue glue

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    Prevalence of postoperative pain evaluated by patient self-assessment using a visual analog scale.

    up to 1 year

Secondary Outcomes (6)

  • Intraoperative complications

    1 day

  • Postoperative complications

    Up to 30 days after index-procedure

  • Analgesic intake

    Discharge, 5 weeks

  • Quality of life (QOL)

    Preoperative, 5 weeks, 1 year

  • Freedom from hernia-related reinterventions

    1 year

  • +1 more secondary outcomes

Study Arms (1)

Patient group

Administration of surgical tissue glue.

Device: Mesh fixation with surgical tissue glue

Interventions

Mesh fixation with surgical tissue glueDEVICE

Laparoscopic inguinal hernia repair using surgical tissue glue for mesh fixation

Patient group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a primary inguinal hernia

You may qualify if:

  • 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™).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Kurt Van der Speeten, MD

    Ziekenhuis Oost-Limburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2012

First Posted

August 21, 2012

Study Start

May 1, 2012

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

June 18, 2020

Record last verified: 2020-06

Locations

BE(1)