10-year Results of Open Inguinal Hernia Repair

10-year Results of Open Inguinal Hernia Repair. A Prospective Study

The main goal of the research is to evaluate the long-term results of open anterior alloplasty of inguinal hernia, mainly the occurrence of recurrences. The secondary aim of the study is to clarify the incidence of chronic pain and foreign body sensation 10 years after inguinal hernia surgery.

Patients who meet the criteria for inclusion in the study are invited to an appointment, where a questionnaire is filled out, an clinical examination and an ultrasound examination are performed.

Study Overview

• Status: Completed
• Conditions: Recurrence; Chronic Pain
• Intervention / Treatment: Procedure: Open inguinal hernia repair

• Study Type: Observational
• Enrollment (Actual): 234

Contacts and Locations

Study Locations

• Estonia
  • Tartumaa
    • Tartu, Tartumaa, Estonia, 50406
      • Tartu University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study group consists of patients who were operated on with a primary inguinal hernia in the department of general surgery and plastic surgery between 2008-2013 at the Tartu University Hospital.

Description

Inclusion Criteria:

• primary inguinal hernia operated between 2008-2013 at the Tartu University Hospital
• elective surgery
• age at least 18 years old at the time of the operation
• ability to understand the guidelines and willing to participate in the study

Exclusion Criteria:

• recurrent hernia
• strangulated hernia
• age under 18 years at the time of surgery
• does not agree to participate in the study
• does not understand the guidelines. Regarding the last exclusion criterion: since it is an assessment of the remote results of the treatment and probably relatively many of the subjects are very elderly, it may happen that when contacting the patient by phone it turns out that the patient is no longer adequate to make a decision about participating in the study or to answer questions (experienced cerebral infarction, dementia, etc. .) - in this case, the patient is not invited to the appointment.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence	Inguinal hernia recurrence on clinical examination or in ultrasound	at 10-year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic pain	Chronic pain after open inguinal hernia repair. The pain questionnaire includes questions about pain at rest, on coughing, when rising from lying to sitting position and during physical effort and exercise (yes-or-no questions). If the answer to these questions are positive, then the pain is measured on visual analogue scale.	at 10-year follow-up

Collaborators and Investigators

• Sponsor: Tartu University Hospital
• Investigators: Principal Investigator: Ceith Nikkolo, PhD, Tartu University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2018
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: July 18, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Chronic Pain; Recurrence
• Other Study ID Numbers: TartuUH_Surgery Clinic

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No