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NCT02932033 Clinical Trial

Trial Comparing Tack Versus Histoacryl Mesh Fixation After Endoscopic TEP(Total Extraperitoneal) Repair for Bilateral Inguinal Hernia

Inguinal Hernia Clinical Trial

— TEP  

Official title:
Randomized Control Trial Comparing Tack Versus Histoacryl Mesh Fixation After Endoscopic TEP (Total Extraperitoneal) Repair for Groin Hernias

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02932033
Other study ID # 05-X18-072
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 28, 2016
Last updated November 2, 2016
Start date November 2016

Study information
Verified date November 2016
Source Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This prospective randomized trial is performed to analyze the post-operative pain (acute and chronic) after endoscopic TEP repair after bilateral inguinal hernia repair.

Description:

consecutive patients with bilateral inguinal hernias will be recruited for TEP repair. Mesh fixation methods spiral tacks glue is randomly assigned to one side to the groin and Histoacryl synthetic glue to the other side. Patients will be followed up regularly for up to 6 months by an independent clinical nurse was blinded to the mesh fixation assignment. The patients are also blinded to the the mesh fixation assignment. The post operative pain score, peri-operative complication, and recurrences will be documented.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Patients present with clinical bilateral inguinal hernias And feasible for general anesthesia

Exclusion Criteria:

- Patient preference for either fixation technique, refusal to participate, previous major lower abdominal surgery, concomitant surgical procedures other than hernia repair, and history of allergy to Histoacryl.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Tack fixation of mesh
hernia mesh is fixed with synthetic glue (Histoacryl) (experimental) or spiral titanium tacks (active comparator) according to the result of randomization
• Synthetic glue fixation
hernia mesh is fixed with synthetic glue (Histoacryl) (experimental) according to the result of randomization

Locations
Country Name City State
Taiwan Buddhist Tzu Chi General Hospital, Taipei branch Taipei

Sponsors (1)
Lead Sponsor Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary acute post-operative pain with VAS 6 hours after OP No
Secondary Chronic pain VAS pain scale 6 months after OP No
Secondary Questionnaire of complications 6 months after OP No
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