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Prevalence of Cholelithiasis with Umbilical Hernia

Prevalence of Cholelithiasis in Patients Presenting with Umbilical Hernia, and Vice Versa: Prospective Multicenter Cross-sectional Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06522308
Enrollment
278
Registered
2024-07-26
Start date
2023-10-01
Completion date
2024-09-30
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholelithiasis, Umbilical Hernia

Brief 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.

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.

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.

Sponsors

Konya Meram State Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with umbilical hernia * Patients with cholelithiasis

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Presence of cholelithiasis in umbilical hernia patients2 daysIn umbilical hernia patients, the presence of cholelithiasis is determined by hepatobiliary ultrasound.
Presence of umbilical hernia in cholelithiasis patients2 daysIn patients with cholelithiasis, the presence of umbilical hernias is determined by superficial tissue ultrasound of the umbilical region.

Secondary

MeasureTime frameDescription
Body mass index2 daysBody mass index is calculated by dividing kilograms by height squared (kilograms / height squared).
The female-male ratio2 daysThe female-male ratio is found by the number of females divided by the number of males (female/male ratio).
Concomitant diseases ratio2 daysIt is found by dividing the number of patients with comorbidities by the total number of patients

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026