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Completed

NCT Number: NCT01000116

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

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.

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Key information

Conditions

Inguinal Hernia Femoral Hernia Hematoma Hemorrhage Hernia Hernia, Abdominal Hernia, Femoral Hernia, Inguinal Inflammation Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Seroma Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Private Hospital Hamlet

Søborg, 2160, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fibrin glue

Procedure

Tissucol 2 ml

Tacks

Procedure

Protacks

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

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Oct 22, 2009
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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