Prevalence of Cholelithiasis with Umbilical Hernia

NCT06522308 | Completed

• 1 other identifier: Hernia Study Group
• Study Type: observational
• Target: 278
• Locations: 1 country
• Sites: 1

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.

Conditions

Umbilical Hernia; Cholelithiasis

Outcome Measures

Primary Outcomes (2)

• Presence of cholelithiasis in umbilical hernia patients

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

  2 days

• 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.

  2 days

Secondary Outcomes (3)

• Body mass index

  2 days

• The female-male ratio

  2 days

• Concomitant diseases ratio

  2 days

Study Arms (2)

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

Hepatobiliary ultrasound DIAGNOSTIC_TEST

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

Umbilical Hernia Group

Umbilical region superficial tissue ultrasound DIAGNOSTIC_TEST

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

Cholelithiasis Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with umbilical hernia
• Patients with cholelithiasis

You may not qualify if:

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

Sponsors & Collaborators

• Konya Meram State Hospital: lead

Study Sites (1)

Konya Training and Research Hospital

Konya, 42090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hernia, Umbilical; Cholelithiasis

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Ventral; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Alpaslan Sahin, MD

  Konya Meram State Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: October 1, 2023
• Primary Completion: August 31, 2024
• Study Completion: September 30, 2024
• Last Updated: January 27, 2025

Record last verified: 2024-10

Locations

TU (1)