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Clinical Trials/NCT02932033
NCT02932033
Unknown
Not Applicable

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

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation1 site in 1 country100 target enrollmentNovember 2016
ConditionsInguinal Hernia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inguinal Hernia
Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Enrollment
100
Locations
1
Primary Endpoint
acute post-operative pain with VAS
Last Updated
9 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
October 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yao-Chou Tsai, Principle investigator

Principal investigator

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Eligibility Criteria

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.

Outcomes

Primary Outcomes

acute post-operative pain with VAS

Time Frame: 6 hours after OP

Secondary Outcomes

  • Chronic pain VAS pain scale(6 months after OP)
  • Questionnaire of complications(6 months after OP)

Study Sites (1)

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