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

Sponsor

Immanuel Kant Baltic Federal University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05920200

Collaborator

(none)

4,000

Enrollment

Location

71.7

Anticipated Duration (Months)

55.8

Patients Per Site Per Month

Study Details

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	Phase
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

Study Type:

Observational

Anticipated 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 :

Jan 9, 2020

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	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 .

Arm

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

Procedure: MIS hernia repair

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

Procedure: MIS hernia repair

Outcome Measures

Primary Outcome Measures

Chronic postoperative pain rate and severity [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 [3 year]
the overall frequency of recurrent hernias

Secondary Outcome Measures

Treatment satisfaction rate [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.