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

Completed

• Conditions: Inguinal Hernia
• Interventions: Device: Mesh fixation with surgical tissue glue

• Registration Number: NCT01669837
• Lead Sponsor: Duomed

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-08-17
• Study First Submitted QC: 2012-08-20
• Study First Posted: 2012-08-21
• Primary Completion: 2020-03
• Study Completion: 2020-03
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-18
• Last Update Posted: 2020-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient group	Mesh fixation with surgical tissue glue	Administration of surgical tissue glue.

Primary Outcome Measures

Name	Time	Method
Postoperative pain	up to 1 year	Prevalence of postoperative pain evaluated by patient self-assessment using a visual analog scale.

Secondary Outcome Measures

Name	Time	Method
Quality of life (QOL)	Preoperative, 5 weeks, 1 year	QOL assessed by EQ-5D questionnaire.
Intraoperative complications	1 day	Complications such as bowel injury, major bleeding, complications due to anesthesia, nerve damage, lesion of vas deferens.
Postoperative complications	Up to 30 days after index-procedure	Local numbness, hematoma, seroma, wound infection, mesh infection, hernia recurrence.
Analgesic intake	Discharge, 5 weeks	Intake of analgesics.
Freedom from hernia-related reinterventions	1 year	Reinterventions at 1 year after index-procedure assessed by means of a questionnaire.
Late complications	1 year	Local numbness, groin discomfort, hernia recurrence, sexual dysfunction

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Limburg, Belgium