Umbilical HerniaNCT06522308
Prevalence of Cholelithiasis with Umbilical Hernia
An observational study of Umbilical Hernia and Cholelithiasis, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial summary
Researchers aim to determine the exact prevalence and risk factors for the association of gallstones and umbilical hernia. Umbilical hernia is defined according to the European Hernia Society Classification for primary and incisional abdominal wall hernias as hernias occurring from 3 cm above to 3 cm below the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Umbilical Hernia, Cholelithiasis
- What is being tested?
- Hepatobiliary ultrasound and Umbilical region superficial tissue ultrasound
- How many people
- 278 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 30 Sep 2024
- 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: All female and male cholelithiasis patients and umbilical hernia patients over the age of 18 who applied during the research period constitute the study population.
Who may be able to join
- Patients with umbilical hernia
- Patients with cholelithiasis
Who cannot join
- Having previously had surgery for an umbilical hernia
- Having undergone abdominal surgery with a median line incision
- having collagen tissue disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Training and Research Hospital
Konya, 42090
About this study
Official title: Prevalence of Cholelithiasis in Patients Presenting with Umbilical Hernia, and Vice Versa: Prospective Multicenter Cross-sectional Study
Researchers aim to determine the exact prevalence and risk factors for the association of gallstones and umbilical hernia. Umbilical hernia is defined according to the European Hernia Society Classification for primary and incisional abdominal wall hernias as hernias occurring from 3 cm above to 3 cm below the umbilicus. The main outcome measures are the presence of gallstones in patients presenting with umbilical hernia and the presence of umbilical hernia in patients diagnosed with gallstones. Patients with umbilical hernia are examined with biliary ultrasound, while patients with cholelithiasis are evaluated for umbilical hernia by physical examination and ultrasound. Factors such as age, gender, body mass index (BMI), family history, comorbidities, tobacco use, parity, and history of multiple pregnancy are analyzed as potential risk factors.
Read the detailed description
Umbilical hernia and cholelithiasis are quite common in general surgical practice. The coexistence of cholelithiasis and umbilical hernia has been previously reported in the literature. However, most of the publications on this subject are retrospective series, and the prevalence of cholelithiasis in patients with umbilical hernia and the risk factors of umbilical hernia in patients with cholelithiasis have not been investigated prospectively to date. This study aims to fill this gap by providing prospective data on the prevalence and risk factors associated with the coexistence of these conditions.
Researchers aim to determine the exact prevalence and risk factors for the association of gallstones and umbilical hernia. Umbilical hernia is defined according to the European Hernia Society Classification for primary and incisional abdominal wall hernias as hernias occurring from 3 cm above to 3 cm below the umbilicus. The main outcome measures are the presence of gallstones in patients presenting with umbilical hernia and the presence of umbilical hernia in patients diagnosed with gallstones. Patients with umbilical hernia are examined with biliary ultrasound, while patients with cholelithiasis are evaluated for umbilical hernia by physical examination and ultrasound. Factors such as age, gender, body mass index (BMI), family history, comorbidities, tobacco use, parity, and history of multiple pregnancy are analyzed as potential risk factors.
- Conditions
- Umbilical Hernia, Cholelithiasis
- Being tested
- Hepatobiliary ultrasound, Umbilical region superficial tissue ultrasound
- Medical subject headings
- Hernia, Umbilical, Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatobiliary ultrasoundDiagnostic test
The presence of cholelithiasis in patients with umbilical hernia is detected by hepatobiliary ultrasound
Umbilical region superficial tissue ultrasoundDiagnostic test
The presence of umbilical hernia in patients with cholelithiasis is detected by ultrasound of the superficial tissue of the umbilical region.
| Study group | Role | What they receive |
|---|---|---|
| Cholelithiasis Group | It is determined whether there is an umbilical hernias in patients with cholelithiasis Receives: Diagnostic Test: Umbilical region superficial tissue ultrasound | |
| Umbilical Hernia Group | It is determined whether patients with umbilical hernia have cholelithiasis or not. Receives: Diagnostic Test: Hepatobiliary ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of cholelithiasis in umbilical hernia patients
In umbilical hernia patients, the presence of cholelithiasis is determined by hepatobiliary ultrasound.
Measured: 2 days
Presence of umbilical hernia in cholelithiasis patients
In patients with cholelithiasis, the presence of umbilical hernias is determined by superficial tissue ultrasound of the umbilical region.
Measured: 2 days
Secondary outcomes (3)
Body mass index
Body mass index is calculated by dividing kilograms by height squared (kilograms / height squared).
Measured: 2 days
The female-male ratio
The female-male ratio is found by the number of females divided by the number of males (female/male ratio).
Measured: 2 days
Concomitant diseases ratio
It is found by dividing the number of patients with comorbidities by the total number of patients
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Oct 2023
- Primary completion31 Aug 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Umbilical 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alpaslan Şahin, Konya Meram State Hospital
- Investigators
- Alpaslan Sahin, MD, Principal investigator, Konya Meram State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522308
- Sponsor's protocol ID
- Hernia Study Group
- Status last verified
- Oct 2024
- First submitted
- 22 Jul 2024
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Cholelithiasis in Patients Presenting with Umbilical Hernia, and Vice Versa: Prospective Multicenter Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06522308
- Acronym / sponsor ID
- Hernia Study Group
- Conditions
- Umbilical Hernia, Cholelithiasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 26 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.
Researchers aim to determine the exact prevalence and risk factors for the association of gallstones and umbilical hernia. Umbilical hernia is defined according to the European Hernia Society Classification for primary and incisional abdominal wall hernias as hernias occurring from 3 cm above to 3 cm below the umbilicus. The main outcome measures are the presence of gallstones in patients presenting with umbilical hernia and the presence of umbilical hernia in patients diagnosed with gallstones. Patients with umbilical hernia are examined with biliary ultrasound, while patients with cholelithiasis are evaluated for umbilical hernia by physical examination and ultrasound. Factors such as age, gender, body mass index (BMI), family history, comorbidities, tobacco use, parity, and history of multiple pregnancy are analyzed as potential risk factors.
Detailed description
Umbilical hernia and cholelithiasis are quite common in general surgical practice. The coexistence of cholelithiasis and umbilical hernia has been previously reported in the literature. However, most of the publications on this subject are retrospective series, and the prevalence of cholelithiasis in patients with umbilical hernia and the risk factors of umbilical hernia in patients with cholelithiasis have not been investigated prospectively to date. This study aims to fill this gap by providing prospective data on the prevalence and risk factors associated with the coexistence of these conditions.
Researchers aim to determine the exact prevalence and risk factors for the association of gallstones and umbilical hernia. Umbilical hernia is defined according to the European Hernia Society Classification for primary and incisional abdominal wall hernias as hernias occurring from 3 cm above to 3 cm below the umbilicus. The main outcome measures are the presence of gallstones in patients presenting with umbilical hernia and the presence of umbilical hernia in patients diagnosed with gallstones. Patients with umbilical hernia are examined with biliary ultrasound, while patients with cholelithiasis are evaluated for umbilical hernia by physical examination and ultrasound. Factors such as age, gender, body mass index (BMI), family history, comorbidities, tobacco use, parity, and history of multiple pregnancy are analyzed as potential risk factors.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholelithiasis Group | – | Diagnostic Test: Umbilical region superficial tissue ultrasoundIt is determined whether there is an umbilical hernias in patients with cholelithiasis |
| Umbilical Hernia Group | – | Diagnostic Test: Hepatobiliary ultrasoundIt is determined whether patients with umbilical hernia have cholelithiasis or not. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All female and male cholelithiasis patients and umbilical hernia patients over the age of 18 who applied during the research period constitute the study population.
Key inclusion criteria (2 listed)
- Patients with umbilical hernia
- Patients with cholelithiasis
Key exclusion criteria (3 listed)
- Having previously had surgery for an umbilical hernia
- Having undergone abdominal surgery with a median line incision
- having collagen tissue disease
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 |
|---|---|---|
| Hepatobiliary ultrasoundThe presence of cholelithiasis in patients with umbilical hernia is detected by hepatobiliary ultrasound | Diagnostic test | Umbilical Hernia Group |
| Umbilical region superficial tissue ultrasoundThe presence of umbilical hernia in patients with cholelithiasis is detected by ultrasound of the superficial tissue of the umbilical region. | Diagnostic test | Cholelithiasis Group |
Primary outcome
Presence of cholelithiasis in umbilical hernia patients
Time frame: 2 days
In umbilical hernia patients, the presence of cholelithiasis is determined by hepatobiliary ultrasound.
Presence of umbilical hernia in cholelithiasis patients
Time frame: 2 days
In patients with cholelithiasis, the presence of umbilical hernias is determined by superficial tissue ultrasound of the umbilical region.
3 secondary outcomes
Body mass index
Time frame: 2 days
The female-male ratio
Time frame: 2 days
Concomitant diseases ratio
Time frame: 2 days
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 27 Jan 2025.
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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.
Alpaslan Sahin, MD principal investigator
Konya Meram State 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 Umbilical Hernia and Cholelithiasis, run by Konya Meram State 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 2 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: finished, as of the sponsor's last update on 27 Jan 2025. 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?
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?
Presence of cholelithiasis in umbilical hernia patients (time frame: 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2025.