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A National Center for Persistent Severe Pain After Groin Hernia Repair

A National Center for Persistent Severe Pain After Groin Hernia Repair: Five-year Prospective Data

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03713047
Acronym
Q5Y
Enrollment
222
Registered
2018-10-19
Start date
2010-01-01
Completion date
2015-09-01
Last updated
2018-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Inguinal Hernia

Keywords

Questionnaire, Long term follow up, Surgical Procedure, Groin hernia repair, Neuropathy, Inflammation, Chronic pain, ADL-functions, Psychometrics, Quantitative sensory testing (QST)

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).

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.

Interventions

None listed

Sponsors

University of Copenhagen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain intensity2010-2015Numeric Rating Scale (NRS; 0-10 units)
Activity of Daily Living (ADL) score2010-2015Activities Assessment Scale (AAS; 8 specified physical activities; 0-8 units each)

Secondary

MeasureTime frameDescription
Assessments of Anxiety and Depression2010-2015Hospital Anxiety and Depression Scale (HADS; 14 item scale; 0-21 units)
Assessment of Pain Catastrophizing2010-2015Pain Catastrophizing Scale (PCS; 13 item scale; 0-65 units)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026