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

April 12, 2012 updated by: Mette Astrup Madsen, Zealand University Hospital

Fibrin Glue Versus Tacked Fixation in Laparoscopic Groin Hernia Repair. A Randomized Double-blind Placebo-controlled Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

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

  • Denmark
      • Søborg, Denmark, 2160
        • Private Hospital Hamlet

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 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

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: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Fibrin glue
Procedure: Tacks
Protacks
ACTIVE_COMPARATOR: Tacks
Procedure: Fibrin glue
Tissucol 2 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Early pain after operation
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
haematoma in groin region
Time Frame: day 10
day 10
seroma in groin region
Time Frame: day 10
day 10
fatigue
Time Frame: 10 days
10 days
discomfort
Time Frame: 6 month
6 month
Postoperative nausea and vomiting (PONV)
Time Frame: 10 days
10 days
Use of Analgesics at PACU
Time Frame: 1 day
1 day

Collaborators and Investigators

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

Sponsor

Zealand University Hospital

Investigators

  • Principal Investigator: Poul Juul, M.D., Private Hospital Hamlet
  • Principal Investigator: Jacob Rosenberg, M.D. DMSc, Herlev Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2009

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

October 16, 2009

First Submitted That Met QC Criteria

October 21, 2009

First Posted (ESTIMATE)

October 22, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 13, 2012

Last Update Submitted That Met QC Criteria

April 12, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJ-138

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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