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

Completed

• Conditions: Chronic Pain; Hernia, Inguinal

• Registration Number: NCT03155230
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2017-05-14
• Study First Submitted QC: 2017-05-15
• Study First Posted: 2017-05-16
• Primary Completion: 2017-07-01
• Study Completion: 2017-10-25
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-21
• Last Update Posted: 2019-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 209

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gastrounit, Surgical Division, Hvidovre Hospital, Denmark; 🇩🇰 Copenhagen, Danmark, Denmark