10-year Results of Open Inguinal Hernia Repair

Sponsor
Tartu University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06008535
Collaborator
(none)
420
1
69.3
6.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Open inguinal hernia repair

Study Design

Study Type:
Observational
Anticipated Enrollment :
420 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
10-year Results of Open Inguinal Hernia Repair. A Prospective Study
Actual Study Start Date :
May 22, 2018
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Recurrence [at 10-year follow-up]

    Inguinal hernia recurrence on clinical examination or in ultrasound

Secondary Outcome Measures

  1. Chronic pain [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tartu University Hospital Tartu Tartumaa Estonia 50406

Sponsors and Collaborators

  • Tartu University Hospital

Investigators

  • Principal Investigator: Ceith Nikkolo, PhD, Tartu University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ceith Nikkolo, general surgeon, Tartu University Hospital
ClinicalTrials.gov Identifier:
NCT06008535
Other Study ID Numbers:
  • TartuUH_Surgery Clinic
First Posted:
Aug 23, 2023
Last Update Posted:
Aug 23, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2023