NCT03155230

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2017

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

2.5 years

First QC Date

May 14, 2017

Last Update Submit

March 21, 2019

Conditions

Hernia, InguinalChronic Pain

Keywords

Inguinal hernia

Outcome Measures

Primary Outcomes (1)

  • Activities Assessment Scale Questionnaire

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

    Within one week

Secondary Outcomes (2)

  • Questionnaire about sexual impairment

    Within three months

  • Questionnaire about sleep impairment

    Within three months

Interventions

no interventionOTHER

no intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastrounit, Surgical Division, Hvidovre Hospital, Denmark

Copenhagen, Danmark, 6000, Denmark

Location

MeSH Terms

Conditions

Hernia, InguinalChronic Pain

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Thue Bisgaard, professor

    HvidovreUT

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 14, 2017

First Posted

May 16, 2017

Study Start

January 1, 2015

Primary Completion

July 1, 2017

Study Completion

October 25, 2017

Last Updated

March 25, 2019

Record last verified: 2019-03

Locations

DK(1)