Prevalence of Cholelithiasis with Umbilical Hernia

Completed

• Conditions: Cholelithiasis; Umbilical Hernia
• Interventions: Diagnostic Test: Umbilical region superficial tissue ultrasound; Diagnostic Test: Hepatobiliary ultrasound

• Registration Number: NCT06522308
• Lead Sponsor: Konya Meram State Hospital

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.

Study Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-25
• Study First Posted: 2024-07-26
• Primary Completion: 2024-08-31
• Study Completion: 2024-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cholelithiasis Group	Umbilical region superficial tissue ultrasound	It is determined whether there is an umbilical hernias in patients with cholelithiasis
Umbilical Hernia Group	Hepatobiliary ultrasound	It is determined whether patients with umbilical hernia have cholelithiasis or not.

Primary Outcome Measures

Name	Time	Method
Presence of cholelithiasis in umbilical hernia patients	2 days	In umbilical hernia patients, the presence of cholelithiasis is determined by hepatobiliary ultrasound.
Presence of umbilical hernia in cholelithiasis patients	2 days	In patients with cholelithiasis, the presence of umbilical hernias is determined by superficial tissue ultrasound of the umbilical region.

Secondary Outcome Measures

Name	Time	Method
Body mass index	2 days	Body mass index is calculated by dividing kilograms by height squared (kilograms / height squared).
The female-male ratio	2 days	The female-male ratio is found by the number of females divided by the number of males (female/male ratio).
Concomitant diseases ratio	2 days	It is found by dividing the number of patients with comorbidities by the total number of patients

Trial Locations

Locations (1)

Konya Training and Research Hospital; 🇹🇷 Konya, Turkey