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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT05920200

Recruitment Status : Recruiting

First Posted : June 27, 2023

Last Update Posted : June 27, 2023

See Contacts and Locations

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Immanuel Kant Baltic Federal University

Study Description

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).

Condition or disease	Intervention/treatment
Inguinal Hernia Femoral Hernia Umbilical Hernia Ventral Hernia Chronic Pain Acute Post Operative Pain Recrrence Rate	Procedure: open non-mesh hernia repair Procedure: open mesh hernia repair Procedure: MIS hernia repair

Study Design

Layout table for study information

Study Type :	Observational
Estimated Enrollment :	4000 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Factors Affecting the Results of Treatment of Patients With Hernias of Various Localization: Evaluation of Treatment Results Using an Automated Hernia Register
Actual Study Start Date :	January 9, 2020
Estimated Primary Completion Date :	December 31, 2023
Estimated Study Completion Date :	December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease Acute Graft Versus Host Disease

U.S. FDA Resources

Groups and Cohorts

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 .

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

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;

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05920200

Contacts

Layout table for location contacts

Contact: Viktor V Kakotkin, MD	+74012595071	Vkakotkin@kantiana.ru

Locations

Layout table for location information

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

Sponsors and Collaborators

Immanuel Kant Baltic Federal University

More Information

Layout table for additonal information

Responsible Party:	Immanuel Kant Baltic Federal University
ClinicalTrials.gov Identifier:	NCT05920200
Other Study ID Numbers:	HR202339
First Posted:	June 27, 2023 Key Record Dates
Last Update Posted:	June 27, 2023
Last Verified:	June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	No individual participant data (IPD) will be available for other researcher.

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Immanuel Kant Baltic Federal University:


hernia register inguinal hernia femoral hernia umbilical hernia	ventral hernia CPIP postoperative complications chronic post-operative pain recurrence rate

Additional relevant MeSH terms:

Layout table for MeSH terms

Hernia, Umbilical Chronic Pain Hernia Pain, Postoperative Hernia, Inguinal Hernia, Ventral Hernia, Femoral	Pain Neurologic Manifestations Pathological Conditions, Anatomical Postoperative Complications Pathologic Processes Hernia, Abdominal Infant, Newborn, Diseases

To Top