Clinical trial NCT06522308: Prevalence of Cholelithiasis with Umbilical Hernia
Official title: Prevalence of Cholelithiasis in Patients Presenting with Umbilical Hernia, and Vice Versa: Prospective Multicenter Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Umbilical Hernia
Cholelithiasis
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of cholelithiasis in umbilical hernia patients
timeFrame: 2 days
measure: Presence of umbilical hernia in cholelithiasis patients
timeFrame: 2 days
Secondary outcomes:
measure: Body mass index
timeFrame: 2 days
measure: The female-male ratio
timeFrame: 2 days
measure: Concomitant diseases ratio
timeFrame: 2 days
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya Training and Research Hospital
Study officials:
affiliation: Konya Meram State Hospital
name: Alpaslan Sahin, MD
role: PRINCIPAL_INVESTIGATOR
References: