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NCT04328597 Clinical Trial

Portuguese Inguinal Hernia Cohort (PINE) Study

Chronic Pain Clinical Trial

— PINE  

Official title:
Portuguese Inguinal Hernia Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04328597
Other study ID # Version 1
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 7, 2019
Est. completion date August 12, 2020

Study information
Verified date March 2020
Source Portuguese Surgical Research Collaborative
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 500
Est. completion date August 12, 2020
Est. primary completion date June 12, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Inguinal hernia repair
Inguinal hernia repair (open, laparo-endoscopic, robotic)

Locations
Country Name City State
Portugal Hospital prof. Dr. Fernando Fonseca Lisboa

Sponsors (2)
Lead Sponsor Collaborator
Portuguese Surgical Research Collaborative University of Lisbon

Country where clinical trial is conducted

Portugal, 

Outcome
Type Measure Description Time frame Safety issue
Primary Chronic postoperative pain Score of 3 or above on the pain domains of the European Registry for Abdominal Wall Hernias Quality of Life (EuraHS QoL) assessment, with higher scores indicating higher pain 3 months postoperatively
Secondary Proportion of patients receiving antibiotic prophylaxis before inguinal hernia repair Intraoperatively
Secondary Proportion of patients operated as day case surgery 30 days after surgery
Secondary Postoperative morbidity 30 days after surgery
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