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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03155230
• Other study ID #: nj01042017
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: October 25, 2017

Study information

• Verified date: March 2019
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: October 25, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Hernia
• Hernia, Inguinal

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
Denmark	Gastrounit, Surgical Division, Hvidovre Hospital, Denmark	Copenhagen	Danmark

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activities Assessment Scale Questionnaire	Impaired daily activities by chronic pain from either one or both groin areas	Within one week
Secondary	Questionnaire about sexual impairment	Sexual impairment due to chronic pain from either one or both groin areas	Within three months
Secondary	Questionnaire about sleep impairment	Sleep impairment due to chronic pain from either one or both groin areas	Within three months