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

NCT ID: NCT00803985

Last Updated: 2018-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

416 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2018-03-31

Brief Summary

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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.

Detailed Description

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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.

Cross-sectional follow-up in median 7.5 years using enquiries for comparison of different pain instruments to evaluate the effect of chronic pain on physical activity.

Conditions

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Chronic Pain Sexual Dysfunction

Keywords

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Inguinal hernia TEP Lichtenstein Mesh Randomized Chronic pain Sexual dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lichtenstein

Open operation with onlay light weight polypropylene mesh

Group Type ACTIVE_COMPARATOR

Total Extraperitoneal repair (TEP)

Intervention Type PROCEDURE

Operation for primary inguinal hernias i men

Total Extraperitoneal repair (TEP)

Laparoscopic operation with preperitoneal nonfixated mesh

Group Type ACTIVE_COMPARATOR

Lichtenstein

Intervention Type PROCEDURE

Operation for primary inguinal hernias i men

Interventions

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Total Extraperitoneal repair (TEP)

Operation for primary inguinal hernias i men

Intervention Type PROCEDURE

Lichtenstein

Operation for primary inguinal hernias i men

Intervention Type PROCEDURE

Other Intervention Names

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Total extraperitoneal patch Laparoscopic hernia operation Hernia mesh operation Open on lay mesh repair Anterior mesh repair

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Region Skane

OTHER

Sponsor Role collaborator

Skane University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Agneta Montgomery

Assosiate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Agneta Montgomery, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Lund

Locations

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Regionala etikprövningsnämden i Lund, avd 2

Lund, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 31162663 (View on PubMed)

Other Identifiers

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596/2007

Identifier Type: -

Identifier Source: org_study_id