Portuguese Inguinal Hernia Cohort (PINE) Study

NCT04328597 | Unknown

• 1 other identifier: Version 1
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Chronic postoperative pain

Patients scoring 3 or more on the EuraHS Quality of Life assessment after elective inguinal hernia repair

Procedure: Inguinal hernia repair

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

Interventions

Inguinal hernia repair PROCEDURE

Inguinal hernia repair (open, laparo-endoscopic, robotic)

Also known as: surgery

Chronic postoperative pain; Non chronic postoperative pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Urgent/emergent inguinal hernia repair

Sponsors & Collaborators

• Portuguese Surgical Research Collaborative: lead
• University of Lisbon: collaborator

Study Sites (1)

Hospital prof. Dr. Fernando Fonseca

Lisbon, Portugal

Location

MeSH Terms

Conditions

Hernia, Inguinal; Chronic Pain

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Antonio Soares

  Portuguese Surgical Research Collaborative

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: March 31, 2020
• Study Start: October 7, 2019
• Primary Completion: June 12, 2020
• Study Completion: August 12, 2020
• Last Updated: April 1, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)