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CompletedNCT06522308Updated Jan 27, 2025

Prevalence of Cholelithiasis with Umbilical Hernia

An observational study in Umbilical Hernia and Cholelithiasis, sponsored by Konya Meram State Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-27.

Sponsored by Konya Meram State Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
278
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Umbilical Hernia
  • Cholelithiasis
03

In context

Hernia, Umbilical

67 studies on the registry are indexed under Hernia, Umbilical; 13 are open to participants now.

This study's enrollment of 278 is above the median of 118 across 25 observational studies indexed under Hernia, Umbilical.

Browse Hernia, Umbilical studies →

Lead sponsor

Konya Meram State Hospital is the lead sponsor of 47 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with umbilical hernia
  • Patients with cholelithiasis

Exclusion criteria

Exclusion Criteria:

  • Having previously had surgery for an umbilical hernia
  • Having undergone abdominal surgery with a median line incision
  • having collagen tissue disease
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
278 participants (actual)
Patient registry
No

Groups and cohorts

  • Cholelithiasis Group

    It is determined whether there is an umbilical hernias in patients with cholelithiasis

    Diagnostic Test: Umbilical region superficial tissue ultrasound

  • Umbilical Hernia Group

    It is determined whether patients with umbilical hernia have cholelithiasis or not.

    Diagnostic Test: Hepatobiliary ultrasound

Interventions

  • Diagnostic testHepatobiliary ultrasound

    The presence of cholelithiasis in patients with umbilical hernia is detected by hepatobiliary ultrasound

  • Diagnostic testUmbilical region superficial tissue ultrasound

    The presence of umbilical hernia in patients with cholelithiasis is detected by ultrasound of the superficial tissue of the umbilical region.

06

What researchers measure

Primary outcomes

  1. Presence of cholelithiasis in umbilical hernia patients

    In umbilical hernia patients, the presence of cholelithiasis is determined by hepatobiliary ultrasound.

    Time frame: 2 days

  2. 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.

    Time frame: 2 days

Secondary outcomes

  1. Body mass index

    Body mass index is calculated by dividing kilograms by height squared (kilograms / height squared).

    Time frame: 2 days

  2. The female-male ratio

    The female-male ratio is found by the number of females divided by the number of males (female/male ratio).

    Time frame: 2 days

  3. Concomitant diseases ratio

    It is found by dividing the number of patients with comorbidities by the total number of patients

    Time frame: 2 days

07

Study locations

1 site
  • Konya Training and Research Hospital
    Konya, 42090, Turkey
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2023 to primary completion in Aug 2024, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 22, 2024
First posted
Jul 26, 2024
StartActual
Oct 1, 2023
Primary completionActual
Aug 31, 2024
CompletionActual
Sep 30, 2024
Last update
Jan 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06522308
Lead sponsor
Konya Meram State Hospital
Responsible party
Alpaslan Şahin (Principal investigator, Konya Meram State Hospital) — Principal investigator
First posted
Jul 26, 2024
Start date
Oct 1, 2023
Primary completion
Aug 31, 2024
Completion
Sep 30, 2024
Last update
Jan 27, 2025

Study contacts

Alpaslan Sahin, MD
principal investigator · Konya Meram State Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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