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.

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Key information

Conditions

Hernia, Inguinal Chronic Pain Hernia Hernia, Abdominal Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Gastrounit, Surgical Division, Hvidovre Hospital, Denmark

Copenhagen, Danmark, 6000, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

Activities Assessment Scale Questionnaire

Time frame: Within one week

Impaired daily activities by chronic pain from either one or both groin areas

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: May 16, 2017
Registry last updated: Mar 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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