10-year Results of Open Inguinal Hernia Repair

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06008535
• Other study ID #: TartuUH_Surgery Clinic
• Status: Completed
• Start date: May 22, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2024
• Source: Tartu University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Hernia, Inguinal
• Recurrence

Intervention

Procedure:
• Open inguinal hernia repair
Lichtenstein hernioplasty or open inguinal hernia repair with self-gripping mesh

Locations

Country	Name	City	State
Estonia	Tartu University Hospital	Tartu	Tartumaa

Sponsors (1)

Lead Sponsor	Collaborator
Tartu University Hospital

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence	Inguinal hernia recurrence on clinical examination or in ultrasound	at 10-year follow-up
Secondary	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