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

NCT ID: NCT02932033

Last Updated: 2016-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Brief Summary

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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

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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.

Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Tack fixation

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.

Group Type ACTIVE_COMPARATOR

Tack fixation of mesh

Intervention Type PROCEDURE

hernia mesh is fixed with synthetic glue (Histoacryl) (experimental) or spiral titanium tacks (active comparator) according to the result of randomization

Synthetic glue fixation

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

Group Type EXPERIMENTAL

Synthetic glue fixation

Intervention Type PROCEDURE

hernia mesh is fixed with synthetic glue (Histoacryl) (experimental) according to the result of randomization

Interventions

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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

Intervention Type PROCEDURE

Synthetic glue fixation

hernia mesh is fixed with synthetic glue (Histoacryl) (experimental) according to the result of randomization

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

OTHER

Sponsor Role lead

Responsible Party

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Yao-Chou Tsai, Principle investigator

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Buddhist Tzu Chi General Hospital, Taipei branch

Taipei, Taiwan, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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05-X18-072

Identifier Type: -

Identifier Source: org_study_id