A National Center for Persistent Severe Pain After Groin Hernia Repair

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).

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Key information

Conditions

Inguinal Hernia Chronic Pain Hernia Hernia, Abdominal Hernia, Inguinal Inflammation Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Pain intensity

Time frame: 2010-2015

Numeric Rating Scale (NRS; 0-10 units)
Activity of Daily Living (ADL) score

Time frame: 2010-2015

Activities Assessment Scale (AAS; 8 specified physical activities; 0-8 units each)

Secondary outcomes

Assessments of Anxiety and Depression

Time frame: 2010-2015

Hospital Anxiety and Depression Scale (HADS; 14 item scale; 0-21 units)
Assessment of Pain Catastrophizing

Time frame: 2010-2015

Pain Catastrophizing Scale (PCS; 13 item scale; 0-65 units)

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

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

Acronym: Q5Y

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: Oct 19, 2018
Registry last updated: Oct 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed