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10-year Results of Open Inguinal Hernia Repair

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06008535
Enrollment
234
Registered
2023-08-23
Start date
2018-05-22
Completion date
2023-12-31
Last updated
2024-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Recurrence

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.

Interventions

Lichtenstein hernioplasty or open inguinal hernia repair with self-gripping mesh

Sponsors

Tartu University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Recurrenceat 10-year follow-upInguinal hernia recurrence on clinical examination or in ultrasound

Secondary

MeasureTime frameDescription
Chronic painat 10-year follow-upChronic 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.

Countries

Estonia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026