NCT00803985

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. Long term cross-sectional follow-up comparing different instruments for measurement of chronic pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2008

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

December 20, 2018

Status Verified

December 1, 2018

Enrollment Period

8.9 years

First QC Date

December 5, 2008

Last Update Submit

December 18, 2018

Conditions

Chronic PainSexual Dysfunction

Keywords

Inguinal herniaTEPLichtensteinMeshRandomizedChronic painSexual dysfunction

Outcome Measures

Primary Outcomes (1)

  • Chronic pain during the last week (IPQ2) 1 year postoperatively measured using question 2 of the Inguinal Pain Questionnaire (IPQ).

    The worst pain last week one year postoperatively. Measured using question 2 of IPQ-questionaire with the cutoff for pain set between grade 2 (pain present but could easily be ignored) and grade 3 (pain present but does not interfere with everyday activities)

    One year

Secondary Outcomes (8)

  • Quality of life measured using the SF-36 questionnaire

    one and three years

  • Chronic pain right now and during the last week (IPQ1 and IPQ2) measured using question 1 and 2 of the inguinal pain questionnaire.

    IPQ1 grade 2-7, IPQ1 grade 3-7 and IPQ2 grade 2-7 measured at one and three years. IPQ2 grad 3-7 measured at three years.

  • Clinical exam assessing groin complaints

    Exams were performed preoperatively, at one and three years

  • A newly developed SexIHS questionnaire designed to specifically address sexual dysfunction associated with a diagnosed inguinal hernia or following inguinal hernia surgery.

    Mean 33 months after surgery

  • Physical function score measuring the ability to perform common daily activities

    The functional score was measured preoperatively, at one and three years

  • +3 more secondary outcomes

Study Arms (2)

Lichtenstein

ACTIVE COMPARATOR

Open operation with onlay light weight polypropylene mesh

Procedure: Total Extraperitoneal repair (TEP)

Total Extraperitoneal repair (TEP)

ACTIVE COMPARATOR

Laparoscopic operation with preperitoneal nonfixated mesh

Procedure: Lichtenstein

Interventions

Total Extraperitoneal repair (TEP)PROCEDURE

Operation for primary inguinal hernias i men

Also known as: Total extraperitoneal patch, Laparoscopic hernia operation, Hernia mesh operation
Lichtenstein
LichtensteinPROCEDURE

Operation for primary inguinal hernias i men

Also known as: Open on lay mesh repair, Anterior mesh repair
Total Extraperitoneal repair (TEP)

Eligibility Criteria

Age30 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regionala etikprövningsnämden i Lund, avd 2

Lund, 221 00, Sweden

Location

Related Publications (1)

  • Gutlic N, Gutlic A, Petersson U, Rogmark P, Montgomery A. Randomized clinical trial comparing total extraperitoneal with Lichtenstein inguinal hernia repair (TEPLICH trial). Br J Surg. 2019 Jun;106(7):845-855. doi: 10.1002/bjs.11230.

    PMID: 31162663DERIVED

MeSH Terms

Conditions

Chronic PainSexual Dysfunction, PhysiologicalHernia, Inguinal

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGenital DiseasesUrogenital DiseasesHernia, AbdominalHerniaPathological Conditions, Anatomical

Study Officials

  • Agneta Montgomery, MD, PhD

    University of Lund

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assosiate professor

Study Record Dates

First Submitted

December 5, 2008

First Posted

December 8, 2008

Study Start

April 1, 2008

Primary Completion

March 1, 2017

Study Completion

March 1, 2018

Last Updated

December 20, 2018

Record last verified: 2018-12

Locations

SE(1)