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

Not Applicable

• Conditions: Inguinal Hernia
• Interventions: Procedure: Tack fixation of mesh; Procedure: Synthetic glue fixation

• Registration Number: NCT02932033
• Lead Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

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.

Study Timeline

• Study First Submitted: 2016-06-28
• Study First Submitted QC: 2016-10-11
• Study First Posted: 2016-10-13
• Status Verified: 2016-11
• Study Start: 2016-11
• Last Update Submitted: 2016-11-02
• Last Update Posted: 2016-11-04
• Primary Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Tack fixation	Tack fixation of mesh	consecutive patients with bilateral inguinal hernias will be recruited for TEP repair. Mesh fixation methods with spiral tack is randomly assigned to one side, then comparative fixation method to the contralateral side. In group of active comparator, after randomization, the target inguinal hernia side of the patient has the mesh fixed with titanium spiral tacks.
Synthetic glue fixation	Synthetic glue fixation	The same patient, his contralateral side of inguinal hernia, has the mesh fixed with synthetic glue.

Primary Outcome Measures

Name	Time	Method
acute post-operative pain with VAS	6 hours after OP

Secondary Outcome Measures

Name	Time	Method
Chronic pain VAS pain scale	6 months after OP
Questionnaire of complications	6 months after OP

Trial Locations

Locations (1)

Buddhist Tzu Chi General Hospital, Taipei branch; 🇨🇳 Taipei, Taiwan