Mesh Fixation inTEP Inguinal Hernia Repair

Inguinal Hernia Clinical Trial

— register  

Official title:

Impact of Mesh Fixation on Chronic Pain in Total Extraperitoneal (TEP) Inguinal Hernia Repair - a National Register Based Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02419950
• Other study ID #: 634/2008
• Status: Completed
• Phase: N/A
• First received: September 24, 2014
• Last updated: April 14, 2015
• Start date: November 2008
• Est. completion date: September 2013

Study information

• Verified date: April 2015
• Source: Skane University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Mesh fixation is used to prevent recurrence in TEP to the potential cost of pain. The aim was to evaluate the impact of permanent fixation (PF) versus non-permanent fixation (N-PF) of mesh in TEP repair for a primary inguinal hernia regarding chronic pain. A cohort of patients were studied for pain interfering with sexual activety. The hyopthesis is that fixation causes pain.

Description:

Mesh fixation is used to prevent recurrence in TEP to the potential cost of pain. The aim was to evaluate the impact of permanent fixation (PF) versus non-permanent fixation (N-PF) of mesh in TEP repair for a primary inguinal hernia regarding chronic pain.

Men between 30 and 75 years, consecutively registered in Swedish Hernia Register (SHR) for a TEP repair between 2005 and 2009 were included. A questionnaire was sent in 2010 including a general questionnaire, SF-36 and Inguinal Pain Questionnaire (IPQ). Primary endpoint was question two in IPQ, "worst pain you felt in the operated groin during this past week". Pain was defined as "pain present that could not be ignored". In adition a specific questionnair developed by the research group on pain and problems during sexual activiety were sent to patients between 30-60 years of age.

The register was checked for long term recurrent operations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1110
• Est. completion date: September 2013
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male between 30-75 years.

• Primary inguinal hernia

Exclusion Criteria:

• Emergency operation

• Operated for recurrence

• Deaths

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Device:
• Fixation of mesh in TEP
An endoscopic operative technique were mesh for preperitonelal placement in patients with inguinal hernias can be fixated in Place or left without fixation

Locations

Country	Name	City	State
Sweden	University of Lund,	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Skane University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

Aasvang EK, Møhl B, Bay-Nielsen M, Kehlet H. Pain related sexual dysfunction after inguinal herniorrhaphy. Pain. 2006 Jun;122(3):258-63. Epub 2006 Mar 20. — View Citation

Eklund A, Rudberg C, Smedberg S, Enander LK, Leijonmarck CE, Osterberg J, Montgomery A. Short-term results of a randomized clinical trial comparing Lichtenstein open repair with totally extraperitoneal laparoscopic inguinal hernia repair. Br J Surg. 2006 Sep;93(9):1060-8. — View Citation

Fränneby U, Gunnarsson U, Andersson M, Heuman R, Nordin P, Nyrén O, Sandblom G. Validation of an Inguinal Pain Questionnaire for assessment of chronic pain after groin hernia repair. Br J Surg. 2008 Apr;95(4):488-93. — View Citation

Kaul A, Hutfless S, Le H, Hamed SA, Tymitz K, Nguyen H, Marohn MR. Staple versus fibrin glue fixation in laparoscopic total extraperitoneal repair of inguinal hernia: a systematic review and meta-analysis. Surg Endosc. 2012 May;26(5):1269-78. doi: 10.1007/s00464-011-2025-2. Epub 2012 Feb 21. Review. — View Citation

Kehlet H, Bay-Nielsen M, Kingsnorth A. Chronic postherniorrhaphy pain--a call for uniform assessment. Hernia. 2002 Dec;6(4):178-81. Epub 2002 Sep 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic pain	Chronic pain is meassured using an Enquirer sent to the patients by mail containing general questions to be able to exclude patients having a chronic pain problem due to other causes than the hernia (like back pain and other operations in the area) SF 36 questionnair for global measures of physical and mental Health and an validated inguinal hernia specific questionnaire for measuring pain, IPQ (Inguinal Pain Questionnair) was used	5 years	Yes
Secondary	Sexual problems due to inguinal pain problems after hernia surgery	A specific questionnair, localy developed, for deltaled information on type, frequency, duration,intensety, disabeling and location of pain together with questions on interferance with errection, ejacculation as well as interferance with general well beeing.	2-5 years	No
Secondary	A second operation for a recurrence	Measured as a reoperation reported in the national register	5-7 years	No