NCT06008535

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2018

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

5.6 years

First QC Date

July 18, 2023

Last Update Submit

April 10, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Recurrence

    Inguinal hernia recurrence on clinical examination or in ultrasound

    at 10-year follow-up

Secondary Outcomes (1)

  • Chronic pain

    at 10-year follow-up

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • recurrent hernia
  • strangulated hernia
  • age under 18 years at the time of surgery
  • does not agree to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tartu University Hospital

Tartu, Tartu, 50406, Estonia

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

RecurrenceChronic Pain

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Ceith Nikkolo, PhD

    Tartu University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
general surgeon

Study Record Dates

First Submitted

July 18, 2023

First Posted

August 23, 2023

Study Start

May 22, 2018

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

April 11, 2024

Record last verified: 2024-04

Locations