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Clinical Trials/NCT06522308
NCT06522308CompletedNot Applicable

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

Konya Meram State Hospital1 site in 1 country278 target enrollmentStarted: October 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
278
Locations
1
Primary Endpoint
Presence of cholelithiasis in umbilical hernia patients

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Presence of cholelithiasis in umbilical hernia patients

Time Frame: 2 days

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

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.

Secondary Outcomes

  • Body mass index(2 days)
  • The female-male ratio(2 days)
  • Concomitant diseases ratio(2 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alpaslan Şahin

Principal investigator

Konya Meram State Hospital

Study Sites (1)

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