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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05920200
• Other study ID #: HR202339
• Status: Recruiting
• Start date: January 9, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: Immanuel Kant Baltic Federal University
• Contact: Viktor V Kakotkin, MD
• Phone: +74012595071
• Email: Vkakotkin[@]kantiana.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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;

Related Conditions & MeSH terms

• Chronic Pain
• Femoral Hernia
• Hernia
• Hernia, Femoral
• Hernia, Inguinal
• Hernia, Umbilical
• Hernia, Ventral
• Inguinal Hernia
• Pain, Postoperative
• Umbilical Hernia
• Ventral Hernia

Intervention

Procedure:
• open non-mesh hernia repair
A groin and femoral hernia non-mesh repair. An umbilical hernia non-mesh repair. A ventral and incisional hernia non-mesh repair.
• open mesh hernia repair
A groin and femoral hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures for Lichtenstein. Self-fixating mesh is also possible. An umbilical, ventral, incisional hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures.
• MIS hernia repair
A groin and femoral minimal invasive hernia repair (TAPP, eTEP). The mesh is affixed with tack/no-fixation. Self-fixation mesh is also possible. An umbilical, ventral, incisional minimal invasive hernia repair (eTEP, IPOM,). The mesh is affixed with tack and no-fixation .

Locations

Country	Name	City	State
Russian Federation	Baltic Federal University	Kaliningrad	Kaliningrad Region

Sponsors (1)

Lead Sponsor	Collaborator
Immanuel Kant Baltic Federal University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic postoperative pain rate and severity	The painDETECT questionnaire will be used to identify chronic postoperative pain.; Final painDETECT Score: 20, indicating that a neuropathic pain component is likely (>90%).	1 year
Primary	Recurrence rate	the overall frequency of recurrent hernias	3 year
Secondary	Treatment satisfaction rate	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.	3 year