Retrospective Analysis of Material From the Hospital DatabaseNCT06530420
The Usefulness of the New EHS/AHS Classification of Primary Umbilical Hernias in the Selection of Method of Their Treatment
An observational study of Retrospective Analysis of Material From the Hospital Database, run by Brothers Hospitallers Hospital in Cracow at 1 site in Poland.
Trial summary
The aim of the study is to assess the usefulness of the new classification of primary umbilical hernias in the choice of treatment of patients. The study is conducted as a retrospective analysis of material from the hospital database Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retrospective Analysis of Material From the Hospital Database
- What is being tested?
- Umbilical hernia repair surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,087 participants
- Where
- 1 sitePoland
- Study dates
- 14 Jun 2024to 20 Dec 2025
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: patients with umbilical hernia operated in the Department of General Surgery of the Hospital of the Brothers Hospitallers in the period from January 2016 to December 2022
Who may be able to join
- Repair surgery for primary umbilical hernia
Who cannot join
- Repair surgery for recurrent umbilical hernia
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Hospital of the Brothers Hospitallers of Saint John of God
Krakow
Nicole Kantor, 668735181
About this study
The aim of the study is to assess the usefulness of the new classification of primary umbilical hernias in the choice of treatment of patients.
The study is conducted as a retrospective analysis of material from the hospital database
Read the detailed description
A retrospective analysis will include patients operated on in the Department of General Surgery of the Hospital of the Brothers Hospitallers in the period from January 2016 to December 2022. The incidence of recurrence will be assessed based on outpatient records and a telephone survey. Hernias will be classified according to the EHS/AHS guidelines as small, medium and large. The qualification will take into account the old and new classification of hernias.
- Being tested
- Umbilical hernia repair surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical hernia repair surgeryProcedure or surgery
collected information about: gender, age, comorbidities, body weight, time of surgery, hernia size and treatment methods and reccurence
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of umbilical hernia recurrence
Measured: 20.12.2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start14 Jun 2024
- Primary completion31 Aug 2024 (estimated)
- Study completion20 Dec 2025 (estimated)
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 Retrospective Analysis of Material From the Hospital DatabaseStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,087 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brothers Hospitallers Hospital in Cracow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole Kantor, Brothers Hospitallers Hospital in Cracow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530420
- Sponsor's protocol ID
- 118.0043.1.167.2024
- Status last verified
- Jul 2024
- First submitted
- 28 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kantor N, Gach T, Orzeszko Z, Kaciczak M, Frycz J, Solecki R, Markowska B, Bogacki P, Szura M. The Usefulness of the New EHS/AHS Classification of Primary Umbilical Hernias in the Selection of the Method of Their Treatment. Pol Przegl Chir. 2025 Jul 29;97(5):25-30. doi: 10.5604/01.3001.0055.2300.
PubMed 41171115
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usefulness of the New EHS/AHS Classification of Primary Umbilical Hernias in the Selection of Method of Their Treatment
- ClinicalTrials.gov ID
- NCT06530420
- Acronym / sponsor ID
- 118.0043.1.167.2024
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,087 participants (estimated)
- Lead sponsor
- Brothers Hospitallers Hospital in CracowUniversity, hospital or other
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 31 Jul 2024 (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 aim of the study is to assess the usefulness of the new classification of primary umbilical hernias in the choice of treatment of patients.
The study is conducted as a retrospective analysis of material from the hospital database
Detailed description
A retrospective analysis will include patients operated on in the Department of General Surgery of the Hospital of the Brothers Hospitallers in the period from January 2016 to December 2022. The incidence of recurrence will be assessed based on outpatient records and a telephone survey. Hernias will be classified according to the EHS/AHS guidelines as small, medium and large. The qualification will take into account the old and new classification of hernias.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients with umbilical hernia operated in the Department of General Surgery of the Hospital of the Brothers Hospitallers in the period from January 2016 to December 2022
Key inclusion criteria (1 listed)
- Repair surgery for primary umbilical hernia
Key exclusion criteria (1 listed)
- Repair surgery for recurrent umbilical hernia
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 |
|---|---|---|
| Umbilical hernia repair surgerycollected information about: gender, age, comorbidities, body weight, time of surgery, hernia size and treatment methods and reccurence | Procedure or surgery | – |
Primary outcome
Incidence of umbilical hernia recurrence
Time frame: 20.12.2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Derived from this study: PubMed 41171115Kantor N, Gach T, Orzeszko Z, Kaciczak M, Frycz J, Solecki R, Markowska B, Bogacki P, Szura M. The Usefulness of the New EHS/AHS Classification of Primary Umbilical Hernias in the Selection of the Method of Their Treatment. Pol Przegl Chir. 2025 Jul 29;97(5):25-30. doi: 10.5604/01.3001.0055.2300.
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.
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 Retrospective Analysis of Material From the Hospital Database, run by Brothers Hospitallers Hospital in Cracow at 1 site in Poland.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 31 Jul 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicole Kantor (668735181, nkantor@interia.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of umbilical hernia recurrence (time frame: 20.12.2025). 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 NCT06530420, 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 31 Jul 2024.