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

Duomed

Status: Completed

Conditions: Inguinal Hernia

Treatments: Device: Mesh fixation with surgical tissue glue

Study type: Observational

Funder types: Industry

Identifiers

NCT01669837

BM-IFA-06

Details and patient eligibility

About

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.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

1,000 participants in 1 patient group

Patient group

Description:

Administration of surgical tissue glue.

Treatment:

Device: Mesh fixation with surgical tissue glue