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CompletedNCT06008535Updated Apr 11, 2024

10-year Results of Open Inguinal Hernia Repair

An observational study in Recurrence and Chronic Pain, sponsored by Tartu University Hospital. Completed at 1 site in Estonia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-11.

Sponsored by Tartu University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
234
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Recurrence
  • Chronic Pain
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In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's enrollment of 234 is above the median of 126 across 688 observational studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Tartu University Hospital is the lead sponsor of 24 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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

Observational model
Case-only
Time perspective
Prospective
Enrollment
234 participants (actual)
Patient registry
No

Interventions

  • ProcedureOpen inguinal hernia repair

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

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What researchers measure

Primary outcomes

  1. Recurrence

    Inguinal hernia recurrence on clinical examination or in ultrasound

    Time frame: at 10-year follow-up

Secondary outcomes

  1. 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.

    Time frame: at 10-year follow-up

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Study locations

1 site
  • Tartu University Hospital
    Tartu, Tartumaa 50406, Estonia
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06008535
Lead sponsor
Tartu University Hospital
Responsible party
Ceith Nikkolo (general surgeon, Tartu University Hospital) — Principal investigator
First posted
Aug 23, 2023
Start date
May 22, 2018
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023
Last update
Apr 11, 2024

Study contacts

Ceith Nikkolo, PhD
principal investigator · Tartu University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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