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Portuguese Inguinal Hernia Cohort (PINE) Study

P

Portuguese Surgical Research Collaborative

Status

Unknown

Conditions

Chronic Pain
Inguinal Hernia

Treatments

Procedure: Inguinal hernia repair

Study type

Observational

Funder types

Other
NETWORK

Identifiers

NCT04328597
Version 1

Details and patient eligibility

About

Prospective national cohort study of patients submitted to elective inguinal hernia repair. The primary outcome is the prevalence of chronic postoperative inguinal pain, according to the EuraHS QoL questionnaire at 3 months postoperatively. The study will be delivered in all Portuguese regions through a collaborative research network. Four 2-week inclusion periods will be open for recruitment. A site-specific questionnaire will capture procedure volume and logistical facilities for hernia surgery.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Elective inguinal hernia repair in a portuguese hospital
  • Willing and able to consent and comply with the follow up protocol

Exclusion criteria

  • Urgent/emergent inguinal hernia repair

Trial design

500 participants in 2 patient groups

Chronic postoperative pain
Description:
Patients scoring 3 or more on the EuraHS Quality of Life assessment after elective inguinal hernia repair
Treatment:
Procedure: Inguinal hernia repair
Non chronic postoperative pain
Description:
Patients scoring less than 3 on the EuraHS Quality of Life assessment after elective inguinal hernia repair
Treatment:
Procedure: Inguinal hernia repair

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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