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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05920200
Enrollment
4000
Registered
2023-06-27
Start date
2020-01-09
Completion date
2025-12-31
Last updated
2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Post Operative Pain, Chronic Pain, Femoral Hernia, Inguinal Hernia, Recrrence Rate, Umbilical Hernia, Ventral Hernia

Keywords

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

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).

Interventions

PROCEDUREopen 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.

PROCEDUREopen 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.

PROCEDUREMIS 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 .

Sponsors

Immanuel Kant Baltic Federal University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Chronic postoperative pain rate and severity1 yearThe painDETECT questionnaire will be used to identify chronic postoperative pain. Final painDETECT Score: 20, indicating that a neuropathic pain component is likely (\>90%).
Recurrence rate3 yearthe overall frequency of recurrent hernias

Secondary

MeasureTime frameDescription
Treatment satisfaction rate3 yearTo 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.

Countries

Russia

Contacts

Primary ContactViktor V Kakotkin, MD
Vkakotkin@kantiana.ru+74012595071

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026