Study Comparing Total Extraperitoneal Patch "TEP" Versus Lichtenstein According Chronic Pain (TEP-LICH)

This study is currently recruiting participants.

Verified December 2008 by Skane University Hospital

Sponsor:

Collaborator:

Region Skane

Information provided by (Responsible Party):

Agneta Montgomery, Skane University Hospital

ClinicalTrials.gov Identifier:

NCT00803985

First received: December 5, 2008

Last updated: May 4, 2012

Last verified: December 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

December 5, 2008

Last Updated Date

May 4, 2012

Start Date ^ICMJE

April 2008

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Worst pain last week one year postoperative (IPQ-questionaire) [ Time Frame: One year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00803985 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

SF36 (physical, mental health and pain), IPQ ( Inguinal Pain Questionaire), specific clinical examination according inguinal nerves symptoms, sexual dysfunction preoperatively, one and tree years after operation. [ Time Frame: three years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study Comparing Total Extraperitoneal Patch "TEP" Versus Lichtenstein According Chronic Pain

Official Title ^ICMJE

Prospective Randomised Study Comparing TEP vs Lichtenstein in Primary Unilateral Inguinal Hernias According Chronic Pain

Brief Summary

The purpose of this study is to se if there is a difference regarding chronic pain and sexual dysfunction one and tree years after laparoscopic un fixated preperitoneal mesh versus gold standard open fixated on lay mesh in inguinal hernia surgery.

Detailed Description

Prospective randomized study comparing total extraperitoneal patch TEP versus open onlay mesh according to Lichtenstein in primary unilateral inguinal hernias in men between 30 to 75 years of age. Non fixated polypropylene mesh is used in the TEP operation and fixated light weight polypropylene mesh is used in the Lichtenstein procedure. The aim is to study chronical pain and sexual dysfunction. Clinical examination according nerve function, hernia status and genital findings are performed together with a questionnaire including SF36, Inguinal Pain Questionnaire(IPQ), sexual function are registered preoperatively, one and tree years postoperatively.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Pain
Sexual Dysfunction

Intervention ^ICMJE

Procedure: Retro-muscular versus on lay mesh

Operation for primary inguinal hernias i men

Other Names:

Open hernia operation
Total extraperitoneal patch
Laparoscopic hernia operation
Hernia mesh operation

Study Arm (s)

Active Comparator: Lichtenstein
Open operation with onlay light weight polypropylene mesh

Intervention: Procedure: Retro-muscular versus on lay mesh
Active Comparator: TEP
Laparoscopic operation with preperitoneal nonfixated mesh

Intervention: Procedure: Retro-muscular versus on lay mesh

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

400

Estimated Completion Date

December 2013

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

men between 30-75 years of age
ASA class I-II
primary unilateral inguinal hernia

Exclusion Criteria:

lower midline incision below linea arcuate
large scrotal hernia
previously or current abuse,mental disease
obesity BMI > 35
another simultaneous operation
nonreducible hernia
severe pain in the groin without nonrelated to hernia
contraindications to general anesthesia
need of language translator
liver cirrhosis or ascites
spread cancer disease
previously irradiation in the area
lack of operations indication

Gender

Male

Ages

30 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Agneta Montgomery, MD, PhD

+4640336562

agneta.montgomery@skane.se

Location Countries ^ICMJE

Sweden

Administrative Information

NCT Number ^ICMJE

NCT00803985

Other Study ID Numbers ^ICMJE

596/2007

Has Data Monitoring Committee

Responsible Party

Agneta Montgomery, Skane University Hospital

Study Sponsor ^ICMJE

Skane University Hospital

Collaborators ^ICMJE

Region Skane

Investigators ^ICMJE

Principal Investigator:

Agneta Montgomery, MD, PhD

University of Lund

Information Provided By

Skane University Hospital

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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