The Outcome After Lichtenstein Operation vs. ProGrip Patch Repair of Inguinal Hernia

Inguinal Hernia Clinical Trial

Official title:

The Effect of Mesh Type on Pain After Surgery for Inguinal Hernia. Randomized Clinical Trial of Lichtenstein Operation With Sutured Polypropylene Patch or Self-adhesive ProGrip Patch.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01026935
• Other study ID #: 231268
• Status: Completed
• Phase: N/A
• First received: December 4, 2009
• Last updated: July 19, 2011
• Start date: February 2008
• Est. completion date: January 2011

Study information

• Verified date: December 2009
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Data Protection BoardFinland: Ethics CommitteeFinland: Finnish Medicines AgencyFinland: Ministry of Social Affairs and HealthFinland: National Advisory Board on Health Care Ethics
• Study type: Interventional

Clinical Trial Summary

For the present study, 400 consecutive men with unilateral primary inguinal hernia are randomized to Lichtenstein repair using either light weight polypropylene mesh (38g/m2) or light weight ProGrip mesh. ProGrip mesh adheres to tissues with polylactic micro hooks without suturing. The primary aim is to examine, whether the ProGrip mesh produces less pain than sutured polypropylene mesh. Secondary outcomes are operation time and convalescence as well as recurrence rate. ProGrip mesh is supposed to be faster to apply as no sutures are needed, which may compensate for its higher cost. The patients are blinded to which mesh they receive.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: January 2011
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• primary unilateral inguinal hernia

Exclusion Criteria:

• not willing to participate

• not capable to understand or fill in the questionnaires

Study Design

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia
• Primary
• Unilateral

Intervention

Device:
• Open inguinal hernia repair
Altogether 400 patients are randomized to receive an open mesh repair with either sutured light weight mesh (38g/m2) or with a non-sutured light weight polypropylene mesh that adheres to tissues with polylactic micro hooks

Locations

Country	Name	City	State
Finland	HUCH Jorvi Hospital, department of Surgery	Espoo
Finland	HUCH Surgical Hospital, Dept of Surgery	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Medtronic - MITG

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative complaints		One year	No
Secondary	Recurrence rate		One year	No