Portuguese Inguinal Hernia Cohort (PINE) Study (PINE)

Portuguese Inguinal Hernia Cohort Study

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Pain; Inguinal Hernia
• Intervention / Treatment: Procedure: Inguinal hernia repair

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Portugal
  • Lisboa, Portugal
    • Hospital Prof. Dr. Fernando Fonseca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Portuguese patients undergoing inguinal hernia repair in one of the hospitals participating in the study

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic postoperative pain; Patients scoring 3 or more on the EuraHS Quality of Life assessment after elective inguinal hernia repair	Procedure: Inguinal hernia repair; Inguinal hernia repair (open, laparo-endoscopic, robotic); Other Names: surgery
Non chronic postoperative pain; Patients scoring less than 3 on the EuraHS Quality of Life assessment after elective inguinal hernia repair	Procedure: Inguinal hernia repair; Inguinal hernia repair (open, laparo-endoscopic, robotic); Other Names: surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Portuguese Surgical Research Collaborative
• Collaborators: University of Lisbon
• Investigators: Study Chair: Antonio Soares, Portuguese Surgical Research Collaborative

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2019
• Primary Completion (Anticipated): June 12, 2020
• Study Completion (Anticipated): August 12, 2020

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (Actual): March 31, 2020

Study Record Updates

• Last Update Posted (Actual): April 1, 2020
• Last Update Submitted That Met QC Criteria: March 30, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Chronic Pain
• Other Study ID Numbers: Version 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans are made to share patient data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No