Prevalence of Cholelithiasis with Umbilical Hernia

NCT ID: NCT06522308

Last Updated: 2025-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

278 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-09-30

Brief Summary

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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

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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

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Umbilical Hernia Cholelithiasis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Cholelithiasis Group

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

Umbilical region superficial tissue ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Umbilical Hernia Group

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

Hepatobiliary ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Hepatobiliary ultrasound

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

Intervention Type DIAGNOSTIC_TEST

Umbilical 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Konya Meram State Hospital

OTHER

Sponsor Role lead

Responsible Party

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Alpaslan Şahin

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alpaslan Sahin, MD

Role: PRINCIPAL_INVESTIGATOR

Konya Meram State Hospital

Locations

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Konya Training and Research Hospital

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Hernia Study Group

Identifier Type: -

Identifier Source: org_study_id

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