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

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ClinicalTrials.gov Identifier: NCT00803985
Recruitment Status : Enrolling by invitation
First Posted : December 8, 2008
Last Update Posted : July 11, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Chronic Pain Sexual Dysfunction Procedure: Retro-muscular versus on lay mesh

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomised Study Comparing TEP vs Lichtenstein in Primary Unilateral Inguinal Hernias According Chronic Pain
Study Start Date : April 2008
Primary Completion Date : January 2016
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Worst pain last week one year postoperative (IPQ-questionaire) [ Time Frame: One year ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00803985


Locations
Sweden
Regionala etikprövningsnämden i Lund, avd 2
Lund, Sweden, 221 00
Sponsors and Collaborators
Skane University Hospital
Region Skane
Investigators
Principal Investigator: Agneta Montgomery, MD, PhD University of Lund
More Information

Responsible Party: Agneta Montgomery, Assosiate professor, Skane University Hospital
ClinicalTrials.gov Identifier: NCT00803985     History of Changes
Other Study ID Numbers: 596/2007
First Posted: December 8, 2008    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms