Randomized Controlled Study Comparing Three Different Techniques for Open Hernia Repair

Inguinal Hernia Clinical Trial

Official title:

Randomized Controlled Study Comparing Three Different Techniques for Open

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01699971
• Other study ID #: 2006/672-31/4
• Status: Completed
• Phase: N/A
• First received: October 1, 2012
• Last updated: October 3, 2012
• Start date: October 2006
• Est. completion date: March 2012

Study information

• Verified date: September 2012
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

The primary aim is to evaluate if PSH and/or ultrapro mesch reduces chronic groin pain postoperatively compared to lichtenstein mesh. The second aim is to evaluate quality of life, recovery from surgery and frequency of recurrencies in the three groups

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 2012
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18-75 years

• unilateral primary hernia

• open surgery

Exclusion Criteria:

• Recurrent Hernia

• Bilateral Hernia

• laparoscopic surgery

• Female

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• Hernia repair
Hernia repair admodum Lichtenstein with polypropylene mesh
• Hernia repair
Hernia repair with Ultra Pro Hernia System (UHS)
• Hernia repair
Hernia repair with Prolene Hernia System(PHS)

Locations

Country	Name	City	State
Sweden	Ersta Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperatively pain	Visual analog scale (VAS)	Postoperative 36 month	No
Secondary	Quality of life	SF36	36 month postoperative	No
Secondary	frequency of recurrencies	check patients journal	postopertive 36 month	No