NCT02932033

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Last Updated

November 4, 2016

Status Verified

November 1, 2016

Enrollment Period

1.9 years

First QC Date

June 28, 2016

Last Update Submit

November 2, 2016

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • acute post-operative pain with VAS

    6 hours after OP

Secondary Outcomes (2)

  • Chronic pain VAS pain scale

    6 months after OP

  • Questionnaire of complications

    6 months after OP

Study Arms (2)

Tack fixation

ACTIVE COMPARATOR

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

Synthetic glue fixation

EXPERIMENTAL

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

Procedure: Synthetic glue fixation

Interventions

Tack fixation of meshPROCEDURE

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

Tack fixation
Synthetic glue fixationPROCEDURE

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

Synthetic glue fixation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients present with clinical bilateral inguinal hernias And feasible for general anesthesia

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Buddhist Tzu Chi General Hospital, Taipei branch

Taipei, Taiwan, 231, Taiwan

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 28, 2016

First Posted

October 13, 2016

Study Start

November 1, 2016

Primary Completion

October 1, 2018

Last Updated

November 4, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)