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Chronic Pain After Groin Hernia Repair

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ClinicalTrials.gov Identifier: NCT02751190
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Umeå University

Brief Summary:
In the present study the investigators aimed to investigate the relationship between surgical methods and chronic pain in over 20 000 patients who underwent groin hernia repair in Sweden

Condition or disease Intervention/treatment
Hernia, Inguinal Hernia, Femoral Procedure: Totally ExtraPeritoneal (TEP) repair Procedure: TransAbdominal PrePeritoneal (TAPP) repair Procedure: Open anterior mesh repair Procedure: Open Anterior Non Mesh Procedure: Combined anterior and posterior repair Procedure: Open preperitoneal mesh repair

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 24607 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Chronic Pain After Groin Hernia Repair, Impact of Method of Surgery
Actual Study Start Date : September 1, 2013
Actual Primary Completion Date : March 1, 2016
Actual Study Completion Date : February 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain Hernia


Intervention Details:
  • Procedure: Totally ExtraPeritoneal (TEP) repair
  • Procedure: TransAbdominal PrePeritoneal (TAPP) repair
  • Procedure: Open anterior mesh repair
    Other Name: Lichtenstein repair
  • Procedure: Open Anterior Non Mesh
    Other Names:
    • McVay
    • Bassani
    • Shouldice
    • Marcy
  • Procedure: Combined anterior and posterior repair
    Other Names:
    • Plug
    • Prolene Hernis System (PHS)
    • Onstep
    • TransInguinalPrePeritoneal repair (TIPP)
  • Procedure: Open preperitoneal mesh repair
    Other Names:
    • Nyhus
    • Stoppa
    • Rives


Primary Outcome Measures :
  1. Chronic post herniorraphy pain [ Time Frame: 1 year ]
    A IPQ score of > 3. Pain, which could not be ignored and affected concentration on activities and leisure activities


Secondary Outcome Measures :
  1. Reoperation for recurrence [ Time Frame: Up to 4 years from primary surgery ]
    Reoperation for recurrence in the same groin (all types of groin hernias)



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients registered in the Swedish hernia surgery.
Criteria

Inclusion criteria:

  • Unilateral, elective, groin hernia repair

Exclusion criteria:

  • Bilateral hernia repair
  • Emergent repair (<24h of duration with signs of incarceration)

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): NCT02751190


Sponsors and Collaborators
Umeå University
Investigators
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Principal Investigator: Pär Nordin, MD.Ph.D Umea University

Additional Information:

Publications:
Nilsson E, Haapaniemi S. Assessing the quality of hernia repair. In: Fitzgibbons RJ, Nyhus LM, eds. Hernia. Philadelphia: Lippincott Williams and Wilkins, 2002:567-73.

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Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT02751190     History of Changes
Other Study ID Numbers: JLL-468171
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Chronic Pain
Hernia
Hernia, Inguinal
Hernia, Femoral
Pain
Neurologic Manifestations
Signs and Symptoms
Pathological Conditions, Anatomical
Hernia, Abdominal