Back to resultsTrial Comparing Tack Versus Histoacryl Mesh Fixation After Endoscopic TEP(Total Extraperitoneal) Repair for Bilateral Inguinal Hernia (TEP)
Primary Purpose
Inguinal Hernia
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Tack fixation of mesh
Synthetic glue fixation
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia
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.
Sites / Locations
- Buddhist Tzu Chi General Hospital, Taipei branch
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Tack fixation
Synthetic glue fixation
Arm 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.
The same patient, his contralateral side of inguinal hernia, has the mesh fixed with synthetic glue.
Outcomes
Primary Outcome Measures
acute post-operative pain with VAS
Secondary Outcome Measures
Chronic pain VAS pain scale
Questionnaire of complications
Full Information
NCT ID
NCT02932033
First Posted
June 28, 2016
Last Updated
November 2, 2016
Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02932033
Brief Title
Trial Comparing Tack Versus Histoacryl Mesh Fixation After Endoscopic TEP(Total Extraperitoneal) Repair for Bilateral Inguinal Hernia
Acronym
TEP
Official Title
Randomized Control Trial Comparing Tack Versus Histoacryl Mesh Fixation After Endoscopic TEP (Total Extraperitoneal) Repair for Groin Hernias
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tack fixation
Arm Type
Active Comparator
Arm 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.
Arm Title
Synthetic glue fixation
Arm Type
Experimental
Arm Description
The same patient, his contralateral side of inguinal hernia, has the mesh fixed with synthetic glue.
Intervention Type
Procedure
Intervention Name(s)
Tack fixation of mesh
Intervention Description
hernia mesh is fixed with synthetic glue (Histoacryl) (experimental) or spiral titanium tacks (active comparator) according to the result of randomization
Intervention Type
Procedure
Intervention Name(s)
Synthetic glue fixation
Intervention Description
hernia mesh is fixed with synthetic glue (Histoacryl) (experimental) according to the result of randomization
Primary Outcome Measure Information:
Title
acute post-operative pain with VAS
Time Frame
6 hours after OP
Secondary Outcome Measure Information:
Title
Chronic pain VAS pain scale
Time Frame
6 months after OP
Title
Questionnaire of complications
Time Frame
6 months after OP
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Buddhist Tzu Chi General Hospital, Taipei branch
City
Taipei
ZIP/Postal Code
231
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Trial Comparing Tack Versus Histoacryl Mesh Fixation After Endoscopic TEP(Total Extraperitoneal) Repair for Bilateral Inguinal Hernia
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