Comparison of Mesh Fixation Wit Cyanoacrylate vs Suture in Inguinal Hernia Surgery

Chronic Pain Clinical Trial

— UHU  

Official title:

Cyanoacrylate vs Suture for Mesh Fixation in Inguinal Hernia Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02197585
• Other study ID #: UHU
• Status: Completed
• Phase: N/A
• First received: July 21, 2014
• Last updated: July 21, 2014
• Start date: June 2007
• Est. completion date: June 2011

Study information

• Verified date: July 2014
• Source: Hospital del Mar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To compare fixation with glubran2 with suture during surgery por primary inguinal hernia.

Hypothesis: Glue may induce less complications and chronic pain than suture

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male patients

• Aged more than 18 years

• Primary inguinal hernia

Exclusion Criteria:

• Inguinoscrotal hernia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Hernia, Inguinal

Intervention

Procedure:
• Inguinal mesh hernioplasty

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital del Mar

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic pain after two years		24 months	Yes