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

Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01000116
• Other study ID #: SJ-138
• Status: Completed
• Phase: N/A
• First received: October 16, 2009
• Last updated: April 12, 2012
• Start date: September 2009
• Est. completion date: February 2012

Study information

• Verified date: April 2012
• Source: University Hospital Koge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: February 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoral Hernia
• Hernia
• Hernia, Femoral
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• Fibrin glue
Tissucol 2 ml
• Tacks
Protacks

Locations

Country	Name	City	State
Denmark	Private Hospital Hamlet	Søborg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Koge

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early pain after operation		1 month	No
Secondary	haematoma in groin region		day 10	No
Secondary	seroma in groin region		day 10	No
Secondary	fatigue		10 days	No
Secondary	discomfort		6 month	No
Secondary	Postoperative nausea and vomiting (PONV)		10 days	No
Secondary	Use of Analgesics at PACU		1 day	No