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

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 Overview

• Status: Completed
• Conditions: Chronic Pain; Hernia, Inguinal
• Intervention / Treatment: Other: no intervention

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).

• Study Type: Observational
• Enrollment (Actual): 209

Contacts and Locations

Study Locations

• Denmark
  • Danmark
    • Copenhagen, Danmark, Denmark, 6000
      • Gastrounit, Surgical Division, Hvidovre Hospital, Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Danish males, age>18 years undergoing elective, bilateral TAPP due to inguinal hernia (medial, lateral, and combined hernias) within the study period from July 1, 2012 to June 30 2013

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Investigators: Study Director: Thue Bisgaard, professor, HvidovreUT

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): October 25, 2017

Study Registration Dates

• First Submitted: May 14, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Inguinal hernia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Chronic Pain
• Other Study ID Numbers: nj01042017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No