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

Buddhist Tzu Chi Medical Foundation

Status: Unknown

Conditions: Inguinal Hernia

Treatments: Procedure: Synthetic glue fixation; Procedure: Tack fixation of mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT02932033

05-X18-072

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Tack fixation

Active Comparator group

Description:

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.

Treatment:

Procedure: Tack fixation of mesh

Synthetic glue fixation

Experimental group

Description:

The same patient, his contralateral side of inguinal hernia, has the mesh fixed with synthetic glue.

Treatment:

Procedure: Synthetic glue fixation