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

NCT ID: NCT05920200

Last Updated: 2024-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-09

Study Completion Date

2025-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with groin and femoral hernia/IG

open non-mesh hernia repair

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

open non-mesh hernia repair

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

open non-mesh hernia repair

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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 .

Interventions

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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.

Intervention Type 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.

Intervention Type 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 .

Intervention Type PROCEDURE

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Immanuel Kant Baltic Federal University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Baltic Federal University

Kaliningrad, Kaliningrad Oblast, Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Viktor V Kakotkin, MD

Role: CONTACT

+74012595071

Facility Contacts

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Viktor V Kakotkin, MD

Role: primary

+74012595071

Other Identifiers

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HR202339

Identifier Type: -

Identifier Source: org_study_id

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