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A National Center for Persistent Severe Pain After Groin Hernia Repair (Q5Y)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03713047
Recruitment Status : Completed
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Information provided by (Responsible Party):
mads u werner, University of Copenhagen

Brief Summary:

This prospective, consecutive cohort study presents nationwide 5-year outcome data on patients with severe persistent pain after groin hernia repair (SPG).

The inclusion criteria were SPG-related impairment of physical and social life. Two-hundred-four out of 222 patients (92%) were analyzed. Relevant surgical records were obtained, and examinations were by standardized clinical and neurophysiological tests. Patients demonstrating pain sensitivity to pressure algometry in the groin were evaluated regarding exploratory surgery, while patients with putative neuropathic pain received pharmacotherapy. Questionnaires at baseline (Q0) and five-year (Q5Y) were used in outcome-analyses of pain-intensity (numeric rating scale [NRS] 0-10) and the pain-related effect on the activity-of-daily-living (Activities Assessment Scale, AAS).

Condition or disease
Inguinal Hernia Chronic Pain

Detailed Description:

Severe persistent pain after groin hernia repair (SPG) causes psychophysical disability and impairs quality-of-life for a considerable number of individuals each year.1-3 In the United States, 600,000 groin hernia repairs (GHR) are performed annually, and a conservative estimate is that 2%, corresponding to 12,000 individuals, each year will develop this debilitating pain condition.4 The management of SPG remains a daunting challenge to the medical profession 5, often requiring multidisciplinary efforts.1,6 Several surgical procedures have indicated substantial pain-relieving effects in SPG1,7 however few well-powered, controlled studies have been presented.8,9 In pharmacological and neuromodulation procedures, most studies are still case-based or uncontrolled.

In 2010, the authors established a dedicated tertiary center for SPG-patients open for referral on a nationwide basis. The objectives were, first, to analyze the pathophysiological mechanism behind the pain, second, to implement optimal medical and surgical pain management and third, to perform clinical SPG-research projects. Standardized clinical and neurophysiological tests guided the management paradigm for each patient. Treatment outcomes were evaluated prospectively using baseline questionnaires (Q0) and a 5-year questionnaire (Q5Y) mailed at the end of 2014 to all patients referred to the center.

The focus of the present study is first, to present clinical, neurophysiological and psychometric data on SPG-patients at referral, and second, to evaluate and compare efficacies of exploratory surgical and non-surgical treatment, based on a consecutive follow-up cohort of 222 patients.

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Study Type : Observational
Actual Enrollment : 222 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A National Center for Persistent Severe Pain After Groin Hernia Repair: Five-year Prospective Data
Actual Study Start Date : January 1, 2010
Actual Primary Completion Date : September 1, 2015
Actual Study Completion Date : September 1, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Primary Outcome Measures :
  1. Pain intensity [ Time Frame: 2010-2015 ]
    Numeric Rating Scale (NRS; 0-10 units)

  2. Activity of Daily Living (ADL) score [ Time Frame: 2010-2015 ]
    Activities Assessment Scale (AAS; 8 specified physical activities; 0-8 units each)

Secondary Outcome Measures :
  1. Assessments of Anxiety and Depression [ Time Frame: 2010-2015 ]
    Hospital Anxiety and Depression Scale (HADS; 14 item scale; 0-21 units)

  2. Assessment of Pain Catastrophizing [ Time Frame: 2010-2015 ]
    Pain Catastrophizing Scale (PCS; 13 item scale; 0-65 units)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with severe persistent pain after groin hernia repair with psychophysical disability referred to the dedicated tertiary center for these patients on a nationwide basis.

Inclusion Criteria:

  • Severe persistent pain after groin hernia repair (activity-related or maximal pain intensity > 7 NRS-units [numeric rating scale 0-10])
  • Severe persistent pain after groin hernia repair-related serious impairment of working and social life.

Exclusion Criteria:

  • Minors or persons of legally incompetence
  • Participants, who do not speak or understand Danish
  • Participants, who cannot cooperate with the investigator or the examination procedure
  • Recurrent hernia
  • Known neurological disease or disorders in the groin area of other origin
  • Psychiatric disease
  • Abuse of alcohol or drugs - according to investigator's evaluation

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 identifier (NCT number): NCT03713047

Sponsors and Collaborators
University of Copenhagen
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Principal Investigator: Mads U Werner, MD, PhD Neuroscience Center, Copenhagen University Hospital, Denmark


Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: mads u werner, Principal Investigator, University of Copenhagen Identifier: NCT03713047     History of Changes
Other Study ID Numbers: H-2-2011-023
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be made available as a supplement to the published scientific article.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by mads u werner, University of Copenhagen:
Long term follow up
Surgical Procedure
Groin hernia repair
Chronic pain
Quantitative sensory testing (QST)

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