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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
  Purpose

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.


Condition Intervention
Chronic Pain
Sexual Dysfunction
 Procedure: Retro-muscular versus on lay mesh

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomised Study Comparing TEP vs Lichtenstein in Primary Unilateral Inguinal Hernias According Chronic Pain

Resource links provided by NLM:

MedlinePlus related topics: Chronic Pain Hernia
U.S. FDA Resources

Further study details as provided by Skane University Hospital:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 400
Study Start Date: April 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lichtenstein
Open operation with onlay light weight polypropylene mesh
 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
Active Comparator: TEP
Laparoscopic operation with preperitoneal nonfixated mesh
 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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00803985

Contacts
Contact: Agneta Montgomery, MD, PhD +4640336562 agneta.montgomery@skane.se

Locations
Sweden
Regionala etikprövningsnämden i Lund, avd 2 Recruiting
Lund, Sweden, 221 00
Principal Investigator: Agneta Montgomery, MD, PhD            
Sub-Investigator: Guthlic Nihad            
Sub-Investigator: Ulf Peterson, MD, PhD            
Sub-Investigator: Peder Rogmark            
Sub-Investigator: Sorin Bedrosian            
Sponsors and Collaborators
Skane University Hospital
Region Skane
Investigators
Principal Investigator: Agneta Montgomery, MD, PhD University of Lund
  More Information

No publications provided

Responsible Party: Agneta Montgomery, Assosiate professor, Skane University Hospital
ClinicalTrials.gov Identifier: NCT00803985     History of Changes
Other Study ID Numbers: 596/2007
Study First Received: December 5, 2008
Last Updated: May 4, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Skane University Hospital:
Inguinal hernia
TEP
Lichtenstein
mesh
 Randomized
Chronic pain
Sexual dysfunction

Additional relevant MeSH terms:
Hernia, Inguinal
Sexual Dysfunctions, Psychological
Hernia, Abdominal
Hernia
 Pathological Conditions, Anatomical
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013