10-year Results of Open Inguinal Hernia Repair

NCT ID: NCT06008535

Last Updated: 2024-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

234 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-22

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Recurrence Chronic Pain

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Open inguinal hernia repair

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tartu University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ceith Nikkolo

general surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ceith Nikkolo, PhD

Role: PRINCIPAL_INVESTIGATOR

Tartu University Hospital

Locations

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Tartu University Hospital

Tartu, Tartu, Estonia

Site Status

Countries

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Estonia

References

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Nikkolo C, Lillsaar T, Vaasna T, Kirsimagi U, Lepner U. Ten-Year Results of Inguinal Hernia Open Mesh Repair. J Abdom Wall Surg. 2025 Jun 9;4:14384. doi: 10.3389/jaws.2025.14384. eCollection 2025.

Reference Type DERIVED
PMID: 40551961 (View on PubMed)

Other Identifiers

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TartuUH_Surgery Clinic

Identifier Type: -

Identifier Source: org_study_id

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