Incarcerated Inguinal HerniaNCT04785430
Incarceration Risk Factors in Inguinal Hernia.
An observational study of Incarcerated Inguinal Hernia and Strangulated Inguinal Hernia, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
It is known that strangulation or necrosis of the intestine within the hernia sac of inguinal hernia increases mortality and morbidity in patients. However, the risks of incarceration in hernias have not been fully revealed.To better understand the factors associated with incarceration in inguinal hernia, the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Incarcerated Inguinal Hernia, Strangulated Inguinal Hernia, Inguinal Hernia
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Jan 2023
- How long will I take part?
- 18 Months
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have applied to the general surgery outpatient clinic of Bakırköy Dr Sadi Konuk Training and Research Hospital, diagnosed with inguinal hernia, and who have applied to the emergency diagnosed with incarcerated inguinal hernia and underwent hernia repair surgery.
Who may be able to join
- Ages between 18-80
- Primary and recurrent inguinal hernias
- Incarcerated / strangulated inguinal hernias
Who cannot join
- Younger than 18, older than 80
- Pregnancy
- Mental retardation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakırkoy Dr.Sadi Konuk Training and Research Hospital
Istanbul
About this study
Official title: Incarceration Risk Factors in Inguinal Hernia.Prospective Observational Clinical Trial.
It is known that strangulation or necrosis of the intestine within the hernia sac of inguinal hernia increases mortality and morbidity in patients. However, the risks of incarceration in hernias have not been fully revealed.To better understand the factors associated with incarceration in inguinal hernia, the investigators will examine patients who will apply to our clinic for inguinal hernia and undergo elective and emergency inguinal hernia surgery.
Read the detailed description
A prospective study will be conducted for 2 years, involving all adult patients who have applied to the general surgery outpatient clinic of Bakırköy Dr Sadi Konuk Training and Research Hospital, diagnosed with inguinal hernia, and who have applied to the emergency diagnosed with incarcerated inguinal hernia and underwent hernia repair surgery.
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent elective inguinal hernia surgery | Patients who have applied to the general surgery outpatient clinic of Bakırköy Dr Sadi Konuk Training and Research Hospital, diagnosed with inguinal hernia and underwent hernia repair surgery. | |
| Patients who underwent emergency inguinal hernia surgery | Patients who have applied to the emergency clinic of Bakırköy Dr Sadi Konuk Training and Research Hospital, diagnosed with incarcerated inguinal hernia and underwent hernia repair surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia defect size
Measurement of fascial defect causing the hernia, using USG or CT
Measured: 2 hours after physical examination
Secondary outcomes (3)
Constipation
Frequent episodes without defecation lasting more than 3 days
Measured: 1 years
Age
Patients age
Measured: up to 24 weeks
Body Mass Index
Patients weight in kilograms divided by the square of height in meters.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Jan 2021
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Incarcerated Inguinal HerniaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Turgut Donmez, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- Turgut Donmez, Study director, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785430
- Sponsor's protocol ID
- BakirkoyEAH Hande1
- Status last verified
- Mar 2021
- First submitted
- 1 Mar 2021
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sneiders D, Yurtkap Y, Kroese LF, Kleinrensink GJ, Lange JF, Gillion JF; Hernia-Club Members. Risk Factors for Incarceration in Patients with Primary Abdominal Wall and Incisional Hernias: A Prospective Study in 4472 Patients. World J Surg. 2019 Aug;43(8):1906-1913. doi: 10.1007/s00268-019-04989-x.
PubMed 30980102Kunduz E, Sormaz IC, Yapalak Y, Bektasoglu HK, Gok AF. Comparison of surgical techniques and results for emergency or elective femoral hernia repair. Ulus Travma Acil Cerrahi Derg. 2019 Nov;25(6):611-615. doi: 10.14744/tjtes.2019.04524.
PubMed 31701494Kandemir H, Donmez T, Surek A, Gumusoglu AY, Karabulut M, Canoz O, Kaya A. Risk factors for incarceration in groin hernia: a prospective observational study. Hernia. 2025 Apr 12;29(1):142. doi: 10.1007/s10029-025-03331-w.
PubMed 40216639
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incarceration Risk Factors in Inguinal Hernia.Prospective Observational Clinical Trial.
- ClinicalTrials.gov ID
- NCT04785430
- Acronym / sponsor ID
- BakirkoyEAH Hande1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 5 Mar 2021 (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.
It is known that strangulation or necrosis of the intestine within the hernia sac of inguinal hernia increases mortality and morbidity in patients. However, the risks of incarceration in hernias have not been fully revealed.To better understand the factors associated with incarceration in inguinal hernia, the investigators will examine patients who will apply to our clinic for inguinal hernia and undergo elective and emergency inguinal hernia surgery.
Detailed description
A prospective study will be conducted for 2 years, involving all adult patients who have applied to the general surgery outpatient clinic of Bakırköy Dr Sadi Konuk Training and Research Hospital, diagnosed with inguinal hernia, and who have applied to the emergency diagnosed with incarcerated inguinal hernia and underwent hernia repair surgery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent elective inguinal hernia surgery | – | –Patients who have applied to the general surgery outpatient clinic of Bakırköy Dr Sadi Konuk Training and Research Hospital, diagnosed with inguinal hernia and underwent hernia repair surgery. |
| Patients who underwent emergency inguinal hernia surgery | – | –Patients who have applied to the emergency clinic of Bakırköy Dr Sadi Konuk Training and Research Hospital, diagnosed with incarcerated inguinal hernia and underwent hernia repair surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have applied to the general surgery outpatient clinic of Bakırköy Dr Sadi Konuk Training and Research Hospital, diagnosed with inguinal hernia, and who have applied to the emergency diagnosed with incarcerated inguinal hernia and underwent hernia repair surgery.
Key inclusion criteria (3 listed)
- Ages between 18-80
- Primary and recurrent inguinal hernias
- Incarcerated / strangulated inguinal hernias
Key exclusion criteria (3 listed)
- Younger than 18, older than 80
- Pregnancy
- Mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hernia defect size
Time frame: 2 hours after physical examination
Measurement of fascial defect causing the hernia, using USG or CT
3 secondary outcomes
Constipation
Time frame: 1 years
Age
Time frame: up to 24 weeks
Body Mass Index
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Background: PubMed 30980102Sneiders D, Yurtkap Y, Kroese LF, Kleinrensink GJ, Lange JF, Gillion JF; Hernia-Club Members. Risk Factors for Incarceration in Patients with Primary Abdominal Wall and Incisional Hernias: A Prospective Study in 4472 Patients. World J Surg. 2019 Aug;43(8):1906-1913. doi: 10.1007/s00268-019-04989-x.
- Background: PubMed 31701494Kunduz E, Sormaz IC, Yapalak Y, Bektasoglu HK, Gok AF. Comparison of surgical techniques and results for emergency or elective femoral hernia repair. Ulus Travma Acil Cerrahi Derg. 2019 Nov;25(6):611-615. doi: 10.14744/tjtes.2019.04524.
- Derived from this study: PubMed 40216639Kandemir H, Donmez T, Surek A, Gumusoglu AY, Karabulut M, Canoz O, Kaya A. Risk factors for incarceration in groin hernia: a prospective observational study. Hernia. 2025 Apr 12;29(1):142. doi: 10.1007/s10029-025-03331-w.
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.
Turgut Donmez study director
Bakirkoy Dr. Sadi Konuk Research and Training 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 Incarcerated Inguinal Hernia and Strangulated Inguinal Hernia, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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 5 Mar 2021. 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 Turkey (Türkiye). 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?
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?
Hernia defect size (time frame: 2 hours after physical examination). 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 NCT04785430, which also lists 3 linked publications.
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 5 Mar 2021.