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

NCT05920200 | Recruiting DMC

• 1 other identifier: HR202339
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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%).

  1 year

• Recurrence rate

  the overall frequency of recurrent hernias

  3 year

Secondary Outcomes (1)

• Treatment satisfaction rate

  3 year

Study Arms (3)

Patients with groin and femoral hernia/IG

Procedure: open non-mesh hernia repair; Procedure: open mesh hernia repair; Procedure: MIS hernia repair

Patients with umbilical hernia/IG

Procedure: open non-mesh hernia repair; Procedure: open mesh hernia repair; Procedure: MIS hernia repair

Patients with ventral and incisional hernia/InG

Procedure: open non-mesh hernia repair; Procedure: open mesh hernia repair; Procedure: MIS hernia repair

Interventions

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.

Patients with groin and femoral hernia/IG; Patients with umbilical hernia/IG; Patients with ventral and incisional hernia/InG

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.

Patients with groin and femoral hernia/IG; Patients with umbilical hernia/IG; Patients with ventral and incisional hernia/InG

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 .

Patients with groin and femoral hernia/IG; Patients with umbilical hernia/IG; Patients with ventral and incisional hernia/InG

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patients not having a 11-digit state-assigned Personal insurance policy number.
• Parastomal hernia;
• infected hernias;

Sponsors & Collaborators

• Immanuel Kant Baltic Federal University: lead

Study Sites (1)

Baltic Federal University

Kaliningrad, Kaliningrad Oblast, 236041, Russia

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal; Hernia, Femoral; Hernia, Umbilical; Hernia, Ventral; Chronic Pain; Pain, Postoperative; Hernia; Postoperative Complications

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pain; Neurologic Manifestations; Signs and Symptoms; Pathologic Processes

Central Study Contacts

Viktor V Kakotkin, MD

CONTACT

+74012595071; Vkakotkin@kantiana.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 27, 2023
• Study Start: January 9, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)