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

ConditionsInguinal HerniaFemoral HerniaUmbilical HerniaVentral HerniaChronic PainAcute Post Operative PainRecrrence Rate
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorImmanuel Kant Baltic Federal University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All mesh and non-mesh repairs that have been registered in the KHR from January 9, 2020, until December 31, 2023.

Disqualifiers

Patients not having a 11-digit state-assigned Personal insurance policy number.

Parastomal hernia;

infected hernias;

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • open non-mesh hernia repair

    Procedure/Surgery

    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

    Procedure/Surgery

    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

    Procedure/Surgery

    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 .

Treatment groups

4,000 Participants
are divided into 3 treatment groups
Group A: Patients with groin and femoral hernia/IG3 interventions
Group B: Patients with umbilical hernia/IG3 interventions
Group C: Patients with ventral and incisional hernia/InG3 interventions

Trial outcomes

Primary outcomes

1

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%).

Time frame
1 year
2

Recurrence rate

the overall frequency of recurrent hernias

Time frame
3 year

Secondary outcomes

1

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.

Time frame
3 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Immanuel Kant Baltic Federal University

Lead sponsor

Source ClinicalTrials.gov
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