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CompletedNCT01000116Updated Aug 26, 2024

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

An interventional study of Fibrin glue and Tacks in Inguinal Hernia and Femoral Hernia, sponsored by Zealand University Hospital. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-26.

Sponsored by Zealand University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Inguinal Hernia
  • Femoral Hernia

Keywords

  • Tapp
  • Early pain
  • well-being
  • Seroma
  • Haematoma
  • Fibrin glue
  • tacks
03

In context

Hernia

1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.

This study's enrollment of 112 is above the median of 80 across 739 interventional studies indexed under Hernia.

Browse Hernia studies →

Lead sponsor

Zealand University Hospital is the lead sponsor of 234 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • converting to open operation
  • low compliance
  • daily use of morphine or similar drugs daily in the last month
  • complications to the operation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
112 participants (actual)

Study arms

  • Active comparator
    Fibrin glue

    Procedure: Tacks

  • Active comparator
    Tacks

    Procedure: Fibrin glue

Interventions

  • ProcedureFibrin glue

    Tissucol 2 ml

  • ProcedureTacks

    Protacks

06

What researchers measure

Primary outcomes

  1. Early pain after operation

    Time frame: 1 month

Secondary outcomes

  1. haematoma in groin region

    Time frame: day 10

  2. seroma in groin region

    Time frame: day 10

  3. fatigue

    Time frame: 10 days

  4. discomfort

    Time frame: 6 month

  5. Postoperative nausea and vomiting (PONV)

    Time frame: 10 days

  6. Use of Analgesics at PACU

    Time frame: 1 day

07

Study locations

1 site
  • Private Hospital Hamlet
    Søborg, 2160, Denmark
08

References and documents

Publications

  • 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. Erratum In: Surg Endosc. 2013 Aug;27(8):2734. PubMed 23355162 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01000116
Lead sponsor
Zealand University Hospital
Responsible party
Mette Astrup Madsen (M.D., Zealand University Hospital) — Principal investigator
First posted
Oct 22, 2009
Start date
Sep 2009
Primary completion
Aug 2011
Completion
Feb 2012
Last update
Aug 26, 2024

Study contacts

Mette A Tolver, M.D.
principal investigator · University Hospital Koege
Thue Bisgaard, M.D. DMSc
principal investigator · University Hospital Koege
Poul Juul, M.D.
principal investigator · Private Hospital Hamlet
Jacob Rosenberg, M.D. DMSc
principal investigator · Herlev Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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