10-year Results of Open Inguinal Hernia Repair

Completed

• Conditions: Recurrence; Chronic Pain

• Registration Number: NCT06008535
• Lead Sponsor: Tartu University Hospital

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-05-22
• Study First Submitted: 2023-07-18
• Study First Submitted QC: 2023-08-22
• Study First Posted: 2023-08-23
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence	at 10-year follow-up	Inguinal hernia recurrence on clinical examination or in ultrasound

Secondary Outcome Measures

Name	Time	Method
Chronic pain	at 10-year follow-up	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.

Trial Locations

Locations (1)

Tartu University Hospital; 🇪🇪 Tartu, Tartumaa, Estonia