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

November 2, 2016 updated by: Yao-Chou Tsai, Principle investigator, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 231
        • Buddhist Tzu Chi General Hospital, Taipei branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
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
EXPERIMENTAL: Synthetic glue fixation
The same patient, his contralateral side of inguinal hernia, has the mesh fixed with synthetic glue.
Procedure: Synthetic glue fixation
hernia mesh is fixed with synthetic glue (Histoacryl) (experimental) according to the result of randomization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
acute post-operative pain with VAS
Time Frame: 6 hours after OP
6 hours after OP

Secondary Outcome Measures

Outcome Measure
Time Frame
Chronic pain VAS pain scale
Time Frame: 6 months after OP
6 months after OP
Questionnaire of complications
Time Frame: 6 months after OP
6 months after OP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (ANTICIPATED)

October 1, 2018

Study Registration Dates

First Submitted

June 28, 2016

First Submitted That Met QC Criteria

October 11, 2016

First Posted (ESTIMATE)

October 13, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

November 4, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-X18-072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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