Portuguese Inguinal Hernia Cohort (PINE) Study

• Conditions: Inguinal Hernia; Chronic Pain
• Interventions: Procedure: Inguinal hernia repair

• Registration Number: NCT04328597
• Lead Sponsor: Portuguese Surgical Research Collaborative

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-07
• Status Verified: 2020-03
• Study First Submitted: 2020-03-25
• Study First Submitted QC: 2020-03-30
• Last Update Submitted: 2020-03-30
• Study First Posted: 2020-03-31
• Last Update Posted: 2020-04-01
• Primary Completion: 2020-06-12
• Study Completion: 2020-08-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Chronic postoperative pain	3 months postoperatively	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

Secondary Outcome Measures

Name	Time	Method
Proportion of patients receiving antibiotic prophylaxis before inguinal hernia repair	Intraoperatively
Proportion of patients operated as day case surgery	30 days after surgery
Postoperative morbidity	30 days after surgery

Trial Locations

Locations (1)

Hospital prof. Dr. Fernando Fonseca; 🇵🇹 Lisboa, Portugal