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NCT Number: NCT05920200

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

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).

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Key information

Conditions

Inguinal Hernia Acute Post Operative Pain Chronic Pain Congenital, Hereditary, and Neonatal Diseases and Abnormalities Femoral Hernia Hernia Hernia, Abdominal Hernia, Femoral Hernia, Inguinal Hernia, Umbilical Hernia, Ventral Infant, Newborn, Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Recrrence Rate Signs and Symptoms Umbilical Hernia Ventral Hernia

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Baltic Federal University

Kaliningrad, Kaliningrad Oblast, 236041, Russia

Location status: Recruiting

Location contact

Mikhail A Agapov, PhD/MD

PRINCIPAL_INVESTIGATOR

Viktor V Kakotkin, MD

CONTACT

[email protected]

+74012595071

Viktor V Kakotkin, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

open non-mesh hernia repair

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

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

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 .

Primary outcomes

  1. 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%).

  2. Recurrence rate

    Time frame: 3 year

    the overall frequency of recurrent hernias

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Viktor V Kakotkin, MD

CONTACT

[email protected]

+74012595071

Sponsors and collaborators

Lead sponsor

Immanuel Kant Baltic Federal University

Other

Registry information

Official study title

Factors Affecting the Results of Treatment of Patients With Hernias of Various Localization: Evaluation of Treatment Results Using an Automated Hernia Register

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jun 27, 2023
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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