AzTrials
AzTrials

Inguinal HerniaQ5YNCT03713047

A National Center for Persistent Severe Pain After Groin Hernia Repair

An observational study of Inguinal Hernia and Chronic Pain, run by University of Copenhagen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Inguinal Hernia, Chronic Pain
How many people
222 participants
Where
No sites listed yet
Study dates
1 Jan 2010to 1 Sep 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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

About this study

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

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).

Read the 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.

Keywords
Questionnaire, Long term follow up, Surgical Procedure, Groin hernia repair, Neuropathy, Inflammation, Chronic pain, ADL-functions, Psychometrics, Quantitative sensory testing (QST)
Medical subject headings
Hernia, Inguinal, Chronic Pain, Inflammation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain intensity

    Numeric Rating Scale (NRS; 0-10 units)

    Measured: 2010-2015

  2. Activity of Daily Living (ADL) score

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

    Measured: 2010-2015

Secondary outcomes (2)

  1. Assessments of Anxiety and Depression

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

    Measured: 2010-2015

  2. Assessment of Pain Catastrophizing

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

    Measured: 2010-2015

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2018
  2. Study start1 Jan 2010
  3. Primary completion1 Sep 2015
  4. Study completion1 Sep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
222 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03713047
Sponsor's protocol ID
H-2-2011-023
Acronym
Q5Y
Status last verified
Oct 2018
First submitted
19 Jul 2018
Last updated
19 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be made available as a supplement to the published scientific article.

Publications

  • Werner MU. Management of persistent postsurgical inguinal pain. Langenbecks Arch Surg. 2014 Jun;399(5):559-69. doi: 10.1007/s00423-014-1211-9. Epub 2014 May 23.

    PubMed 24849039

  • Nikkolo C, Kirsimagi U, Vaasna T, Murruste M, Suumann J, Seepter H, Lepner U. Prospective study evaluating the impact of severity of chronic pain on quality of life after inguinal hernioplasty. Hernia. 2017 Apr;21(2):199-205. doi: 10.1007/s10029-016-1569-4. Epub 2016 Dec 26.

    PubMed 28025741

  • Niccolai P, Ouchchane L, Libier M, Beouche F, Belon M, Vedrinne JM, El Drayi B, Vallet L, Ruiz F, Biermann C, Duchene P, Chirat C, Soule-Sonneville S, Duale C, Dubray C, Schoeffler P. Persistent neuropathic pain after inguinal herniorrhaphy depending on the procedure (open mesh v. laparoscopy): a propensity-matched analysis. Can J Surg. 2015 Apr;58(2):114-20. doi: 10.1503/cjs.008314.

    PubMed 25799247

  • Cohen SP, Raja SN. Prevention of chronic postsurgical pain: the ongoing search for the holy grail of anesthesiology. Anesthesiology. 2013 Feb;118(2):241-3. doi: 10.1097/ALN.0b013e31827d4129. No abstract available.

    PubMed 23340346

  • Kehlet H, Roumen RM, Reinpold W, Miserez M. Invited commentary: Persistent pain after inguinal hernia repair: what do we know and what do we need to know? Hernia. 2013 Jun;17(3):293-7. doi: 10.1007/s10029-013-1109-4. Epub 2013 May 21. No abstract available.

    PubMed 23686405

  • Chen DC, Hiatt JR, Amid PK. Operative management of refractory neuropathic inguinodynia by a laparoscopic retroperitoneal approach. JAMA Surg. 2013 Oct;148(10):962-7. doi: 10.1001/jamasurg.2013.3189.

    PubMed 23903521

  • Magnusson N, Gunnarsson U, Nordin P, Smedberg S, Hedberg M, Sandblom G. Reoperation for persistent pain after groin hernia surgery: a population-based study. Hernia. 2015 Feb;19(1):45-51. doi: 10.1007/s10029-014-1340-7. Epub 2014 Dec 18.

    PubMed 25519077

  • Nikkolo C, Lepner U. Chronic pain after open inguinal hernia repair. Postgrad Med. 2016 Jan;128(1):69-75. doi: 10.1080/00325481.2016.1121090. Epub 2015 Dec 4.

    PubMed 26567717

  • Kehlet H, Bay-Nielsen M; Danish Hernia Database Collaboration. Nationwide quality improvement of groin hernia repair from the Danish Hernia Database of 87,840 patients from 1998 to 2005. Hernia. 2008 Feb;12(1):1-7. doi: 10.1007/s10029-007-0285-5. Epub 2007 Oct 16.

    PubMed 17939015

  • McCarthy M Jr, Jonasson O, Chang CH, Pickard AS, Giobbie-Hurder A, Gibbs J, Edelman P, Fitzgibbons R, Neumayer L. Assessment of patient functional status after surgery. J Am Coll Surg. 2005 Aug;201(2):171-8. doi: 10.1016/j.jamcollsurg.2005.03.035.

    PubMed 16038812

  • Aasvang EK, Gmaehle E, Hansen JB, Gmaehle B, Forman JL, Schwarz J, Bittner R, Kehlet H. Predictive risk factors for persistent postherniotomy pain. Anesthesiology. 2010 Apr;112(4):957-69. doi: 10.1097/ALN.0b013e3181d31ff8.

    PubMed 20234307

  • Bischoff JM, Koscielniak-Nielsen ZJ, Kehlet H, Werner MU. Ultrasound-guided ilioinguinal/iliohypogastric nerve blocks for persistent inguinal postherniorrhaphy pain: a randomized, double-blind, placebo-controlled, crossover trial. Anesth Analg. 2012 Jun;114(6):1323-9. doi: 10.1213/ANE.0b013e31824d6168. Epub 2012 Mar 30.

    PubMed 22467891

  • Aasvang EK, Kehlet H. Persistent sensory dysfunction in pain-free herniotomy. Acta Anaesthesiol Scand. 2010 Mar;54(3):291-8. doi: 10.1111/j.1399-6576.2009.02137.x. Epub 2009 Oct 15.

    PubMed 19839945

  • Jensen EK, Ringsted TK, Bischoff JM, Petersen MA, Rosenberg J, Kehlet H, Werner MU. A national center for persistent severe pain after groin hernia repair: Five-year prospective data. Medicine (Baltimore). 2019 Aug;98(33):e16600. doi: 10.1097/MD.0000000000016600.

    PubMed 31415351

Questions about this trial

What is this clinical trial studying?

An observational study of Inguinal Hernia and Chronic Pain, run by University of Copenhagen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain intensity (time frame: 2010-2015). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03713047, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2018.

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