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

Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669837
• Other study ID #: BM-IFA-06
• Status: Completed
• Start date: May 2012
• Est. completion date: March 2020

Study information

• Verified date: June 2020
• Source: Duomed
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Device:
• Mesh fixation with surgical tissue glue
Laparoscopic inguinal hernia repair using surgical tissue glue for mesh fixation

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Duomed

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	Prevalence of postoperative pain evaluated by patient self-assessment using a visual analog scale.	up to 1 year
Secondary	Intraoperative complications	Complications such as bowel injury, major bleeding, complications due to anesthesia, nerve damage, lesion of vas deferens.	1 day
Secondary	Postoperative complications	Local numbness, hematoma, seroma, wound infection, mesh infection, hernia recurrence.	Up to 30 days after index-procedure
Secondary	Analgesic intake	Intake of analgesics.	Discharge, 5 weeks
Secondary	Quality of life (QOL)	QOL assessed by EQ-5D questionnaire.	Preoperative, 5 weeks, 1 year
Secondary	Freedom from hernia-related reinterventions	Reinterventions at 1 year after index-procedure assessed by means of a questionnaire.	1 year
Secondary	Late complications	Local numbness, groin discomfort, hernia recurrence, sexual dysfunction	1 year