RecurrenceNCT06008535
10-year Results of Open Inguinal Hernia Repair
An observational study of Recurrence and Chronic Pain, run by Tartu University Hospital at 1 site in Estonia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrence, Chronic Pain
- What is being tested?
- Open inguinal hernia repair
- Type of treatment
- Surgery or procedure
- How many people
- 234 participants
- Where
- 1 siteEstonia
- Study dates
- 22 May 2018to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 10-year Results of Open Inguinal Hernia Repair. A Prospective Study
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.
- Conditions
- Recurrence, Chronic Pain
- Being tested
- Open inguinal hernia repair
- Medical subject headings
- Recurrence, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open inguinal hernia repairProcedure or surgery
Lichtenstein hernioplasty or open inguinal hernia repair with self-gripping mesh
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Inguinal hernia recurrence on clinical examination or in ultrasound
Measured: 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.
Measured: at 10-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start22 May 2018
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RecurrenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tartu University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceith Nikkolo, Tartu University Hospital
- Investigators
- Ceith Nikkolo, PhD, Principal investigator, Tartu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008535
- Sponsor's protocol ID
- TartuUH_Surgery Clinic
- Status last verified
- Apr 2024
- First submitted
- 18 Jul 2023
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40551961
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 10-year Results of Open Inguinal Hernia Repair. A Prospective Study
- ClinicalTrials.gov ID
- NCT06008535
- Acronym / sponsor ID
- TartuUH_Surgery Clinic
- Conditions
- Recurrence, Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Tartu University HospitalUniversity, hospital or other
- Study start
- 22 May 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open inguinal hernia repairLichtenstein hernioplasty or open inguinal hernia repair with self-gripping mesh | Procedure or surgery | – |
Primary outcome
Recurrence
Time frame: at 10-year follow-up
Inguinal hernia recurrence on clinical examination or in ultrasound
1 secondary outcome
Chronic pain
Time frame: at 10-year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Derived from this study: PubMed 40551961Nikkolo 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ceith Nikkolo, PhD principal investigator
Tartu University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrence and Chronic Pain, run by Tartu University Hospital at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: at 10-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06008535, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.