Factors Influencing the Results of Treatment in Patients With Hernias of Various Localizations

Recruiting

• Conditions: Femoral Hernia; Chronic Pain; Inguinal Hernia; Umbilical Hernia; Acute Post Operative Pain; Ventral Hernia; Recrrence Rate
• Interventions: Procedure: open non-mesh hernia repair; Procedure: open mesh hernia repair; Procedure: MIS hernia repair

• Registration Number: NCT05920200
• Lead Sponsor: Immanuel Kant Baltic Federal University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-09
• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-06-22
• Study First Posted: 2023-06-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4000

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with groin and femoral hernia/IG	open mesh hernia repair	-
Patients with groin and femoral hernia/IG	open non-mesh hernia repair	-
Patients with umbilical hernia/IG	open non-mesh hernia repair	-
Patients with umbilical hernia/IG	MIS hernia repair	-
Patients with groin and femoral hernia/IG	MIS hernia repair	-
Patients with umbilical hernia/IG	open mesh hernia repair	-
Patients with ventral and incisional hernia/InG	open mesh hernia repair	-
Patients with ventral and incisional hernia/InG	MIS hernia repair	-
Patients with ventral and incisional hernia/InG	open non-mesh hernia repair	-

Primary Outcome Measures

Name	Time	Method
Chronic postoperative pain rate and severity	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	3 year	the overall frequency of recurrent hernias

Secondary Outcome Measures

Name	Time	Method
Treatment satisfaction rate	3 year	To assess the quality of life will be used Eura HS Quality of Life Scale-EuraHS QoL.; EuraHS Qol - total (min - 0, max - 90) EuraHS Qol - pain (min - 0, max - 30) EuraHS Qol - restriction of activities (min - 0, max - 40) EuraHS Qol - cosmetic discomfort (min -0, max - 20); Higher scores mean a worse outcome.

Trial Locations

Locations (1)

Baltic Federal University; 🇷🇺 Kaliningrad, Kaliningrad Region, Russian Federation