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

Cyanoacrylate Fixation for Laparoscopic Repair of Inguinal Hernias: a Prospective, Multicenter Registry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01669837

Enrollment

1000

Registered

2012-08-21

Start date

2012-05-31

Completion date

2020-03-31

Last updated

2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia

Keywords

Inguinal hernia, Laparoscopy, Surgical tissue glue

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.

Interventions

DEVICEMesh fixation with surgical tissue glue

Laparoscopic inguinal hernia repair using surgical tissue glue for mesh fixation

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.
Intraoperative complications	1 day	Complications such as bowel injury, major bleeding, complications due to anesthesia, nerve damage, lesion of vas deferens.
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
Quality of life (QOL)	Preoperative, 5 weeks, 1 year	QOL assessed by EQ-5D questionnaire.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026