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临床试验/NCT06522308
NCT06522308已完成不适用

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

Konya Meram State Hospital1 个研究点 分布在 1 个国家目标入组 278 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
278
试验地点
1
主要终点
Presence of cholelithiasis in umbilical hernia patients

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with umbilical hernia
  • Patients with cholelithiasis

排除标准

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

结局指标

主要结局

Presence of cholelithiasis in umbilical hernia patients

时间窗: 2 days

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

Presence of umbilical hernia in cholelithiasis patients

时间窗: 2 days

In patients with cholelithiasis, the presence of umbilical hernias is determined by superficial tissue ultrasound of the umbilical region.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alpaslan Şahin

Principal investigator

Konya Meram State Hospital

研究点 (1)

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