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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Viktor V Kakotkin, MD
- Phone Number: +74012595071
- Email: Vkakotkin@kantiana.ru
Study Locations
-
-
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
Sampling Method
Study Population
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?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with groin and femoral hernia/IG
|
A groin and femoral hernia non-mesh repair.
An umbilical hernia non-mesh repair.
A ventral and incisional hernia non-mesh 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. 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
|
A groin and femoral hernia non-mesh repair.
An umbilical hernia non-mesh repair.
A ventral and incisional hernia non-mesh 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. 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
|
A groin and femoral hernia non-mesh repair.
An umbilical hernia non-mesh repair.
A ventral and incisional hernia non-mesh 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. 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
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%). |
1 year
|
|
Recurrence rate
Time Frame: 3 year
|
the overall frequency of recurrent hernias
|
3 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment satisfaction rate
Time Frame: 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. |
3 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HR202339
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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