Factors Affecting the Results of Treatment of Patients With Hernias of Various Localization: Evaluation of Treatment Results Using an Automated Hernia Register

Immanuel Kant Baltic Federal University1 site in 1 country4,000 target enrollmentJanuary 9, 2020

ConditionsInguinal Hernia Femoral Hernia Umbilical Hernia Ventral Hernia Chronic Pain Acute Post Operative Pain Recrrence Rate

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Inguinal Hernia
Sponsor: Immanuel Kant Baltic Federal University
Enrollment: 4000
Locations: 1
Primary Endpoint: Chronic postoperative pain rate and severity
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study attempts to quantify the relative risks for acute postoperative pain, complications rate, chronic postoperative pain (CPIP) and recurrence rate after different methods of repair of groin, umbilical and incisional hernia depending on surgical technique, mesh type and fixation suture material.

For this purpose the investigators will analyze data from the Kalinigrad Hernia Registry (KHR).

Registry

clinicaltrials.gov

Start Date

January 9, 2020

End Date

December 31, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Immanuel Kant Baltic Federal University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All mesh and non-mesh repairs that have been registered in the KHR from January 9, 2020, until December 31, 2023.

Exclusion Criteria

•Patients not having a 11-digit state-assigned Personal insurance policy number.
•Parastomal hernia;
•infected hernias;

Outcomes

Primary Outcomes

Chronic postoperative pain rate and severity

Time Frame: 1 year

The painDETECT questionnaire will be used to identify chronic postoperative pain. Final painDETECT Score: 20, indicating that a neuropathic pain component is likely (\>90%).

Recurrence rate

Time Frame: 3 year

the overall frequency of recurrent hernias