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

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

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).

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: Viktor V Kakotkin, MD; Phone Number: +74012595071; Email: Vkakotkin@kantiana.ru

Study Locations

• Russian Federation
  • Kaliningrad Region
    • Kaliningrad, Kaliningrad Region, Russian Federation, 236041
      • Recruiting
      • Baltic Federal University
      • Contact: Viktor V Kakotkin, MD; Phone Number: +74012595071; Email: Vkakotkin@kantiana.ru
      • Principal Investigator: Mikhail A Agapov, PhD/MD
      • Sub-Investigator: Viktor V Kakotkin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

An unselected, consecutive regionwide cohort during 3 years, with a 3-year follow-up

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with groin and femoral hernia/IG	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.; Procedure: 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.; Procedure: 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 .
Patients with umbilical hernia/IG	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.; Procedure: 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.; Procedure: 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 .
Patients with ventral and incisional hernia/InG	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.; Procedure: 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.; Procedure: 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Recurrence rate	the overall frequency of recurrent hernias	3 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Immanuel Kant Baltic Federal University

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2020
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: June 22, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: hernia; ventral hernia; recurrence rate; postoperative complications; inguinal hernia; umbilical hernia; register; chronic post-operative pain; femoral hernia; CPIP
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Infant, Newborn, Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Pain, Postoperative; Hernia; Hernia, Inguinal; Chronic Pain; Hernia, Ventral; Hernia, Umbilical; Hernia, Femoral
• Other Study ID Numbers: HR202339

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data (IPD) will be available for other researcher.

Drug and device information, study documents

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