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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01000116
Other study ID # SJ-138
Secondary ID
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


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
See also
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Completed NCT05159232 - Length of Hospital Stay in Laparoscopic Transabdominal Preperitoneal Vs. Open Mesh Repair in Inguinal Hernia: A Randomised Controlled Trial N/A
Completed NCT05107986 - Laparoscopy in Complicated Groin Hernia
Active, not recruiting NCT04328597 - Portuguese Inguinal Hernia Cohort (PINE) Study
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Completed NCT03590145 - Reliability of the Doha Agreement Classification of Groin Pain