Fibrin Glue Versus Tacked Fixation in Groin Hernia Repair (TAPP)

NCT ID: NCT01000116

Last Updated: 2024-08-26

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

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-02-29

Brief Summary

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In this study the researchers want to compare fibrin glue versus tacked fixation in fixation of the mesh in laparoscopic groin hernia repair. The primary endpoints are early pain in the first 3 days postoperative days. Moreover, the researchers investigate general well-being, fatigue, seroma, haematoma, postoperative nausea and vomiting. Thirdly, they are investigating chronic pain and clinical recurrence.

Detailed Description

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Conditions

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Inguinal Hernia Femoral Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fibrin glue

Group Type ACTIVE_COMPARATOR

Tacks

Intervention Type PROCEDURE

Protacks

Tacks

Group Type ACTIVE_COMPARATOR

Fibrin glue

Intervention Type PROCEDURE

Tissucol 2 ml

Interventions

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Fibrin glue

Tissucol 2 ml

Intervention Type PROCEDURE

Tacks

Protacks

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* unilateral groin hernia
* planned laparoscopic inguinal or femoral herniorrhaphy
* ASA I-III
* fluent Danish

Exclusion Criteria

* converting to open operation
* low compliance
* daily use of morphine or similar drugs daily in the last month
* complications to the operation
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mette Astrup Madsen

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mette A Tolver, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Koege

Thue Bisgaard, M.D. DMSc

Role: PRINCIPAL_INVESTIGATOR

University Hospital Koege

Poul Juul, M.D.

Role: PRINCIPAL_INVESTIGATOR

Private Hospital Hamlet

Jacob Rosenberg, M.D. DMSc

Role: PRINCIPAL_INVESTIGATOR

Herlev Hospital

Locations

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Private Hospital Hamlet

Søborg, , Denmark

Site Status

Countries

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Denmark

References

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Tolver MA, Rosenberg J, Juul P, Bisgaard T. Randomized clinical trial of fibrin glue versus tacked fixation in laparoscopic groin hernia repair. Surg Endosc. 2013 Aug;27(8):2727-33. doi: 10.1007/s00464-012-2766-6. Epub 2013 Jan 26.

Reference Type DERIVED
PMID: 23355162 (View on PubMed)

Other Identifiers

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SJ-138

Identifier Type: -

Identifier Source: org_study_id

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