Prevalence of Cholelithiasis with Umbilical Hernia

January 22, 2025 updated by: Alpaslan Şahin, Konya Meram State Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

278

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey, 42090
        • Konya Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cholelithiasis Group
It is determined whether there is an umbilical hernias in patients with cholelithiasis
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.
Umbilical Hernia Group
It is determined whether patients with umbilical hernia have cholelithiasis or not.
Diagnostic test: Hepatobiliary ultrasound
The presence of cholelithiasis in patients with umbilical hernia is detected by hepatobiliary ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of cholelithiasis in umbilical hernia patients
Time Frame: 2 days
In umbilical hernia patients, the presence of cholelithiasis is determined by hepatobiliary ultrasound.
2 days
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.
2 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konya Meram State Hospital

Investigators

  • Principal Investigator: Alpaslan Sahin, MD, Konya Meram State Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

August 31, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

July 22, 2024

First Submitted That Met QC Criteria

July 25, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hernia Study Group

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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