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OpenTrials
Completed

NCT Number: NCT06008535

10-year Results of Open Inguinal Hernia Repair

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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Key information

Conditions

Recurrence Chronic Pain Disease Attributes Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tartu University Hospital

Tartu, 50406, Estonia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Open Inguinal Hernia Repair

Procedure

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

Primary outcomes

  1. Recurrence

    Time frame: at 10-year follow-up

    Inguinal hernia recurrence on clinical examination or in ultrasound

Secondary outcomes

  1. Chronic pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tartu University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Aug 23, 2023
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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