Nationwide Results on Chronic Pain After Bilateral Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP)

Overview

Danish male patients who had undergone bilateral TAPP (July 2012 to June 2013) were recruited from the Danish Hernia Database and cross-checked with hospital files and the National Patient Registry. A standardized postal questionnaire was sent out two years after the index surgery to investigate Patients Related Outcome Measures (PROMs) such as chronic post-operative pain.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 1, 2017

Detailed Description

The present study was primarily undertaken to provide evidence for the risk of activity-related chronic postoperative inguinal pain following bilateral TAPP in an all-male Danish setting. Impaired sexual activity and sleep disturbance due to pain was also recorded. Data based on nationwide consecutive patients undergoing bilateral TAPP. Data collected for the Danish Inguinal Hernia Database, hospital files and the National Patient Registry (Denmark).

Interventions

  • Other: no intervention
    • no intervention

Clinical Trial Outcome Measures

Primary Measures

  • Activities Assessment Scale Questionnaire
    • Time Frame: Within one week
    • Impaired daily activities by chronic pain from either one or both groin areas

Secondary Measures

  • Questionnaire about sexual impairment
    • Time Frame: Within three months
    • Sexual impairment due to chronic pain from either one or both groin areas
  • Questionnaire about sleep impairment
    • Time Frame: Within three months
    • Sleep impairment due to chronic pain from either one or both groin areas

Participating in This Clinical Trial

Inclusion Criteria

  • Danish males, – Age>18 years – Elective, bilateral TAPP due to inguinal hernia within the period from July 1, 2012 to June 30 2013 Exclusion Criteria:

  • age <18 years – miss-classified surgical code – non-Danish speaking – psychiatric anamneses – regarded and non-compliant patients who had either died, emigrated or were lost to follow-up emergency repair – femoral hernia repair

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hvidovre University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Niels Johansen, Principal Investigator – Hvidovre University Hospital
  • Overall Official(s)
    • Thue Bisgaard, professor, Study Director, HvidovreUT

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