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临床试验/NCT05061589
NCT05061589Unknown不适用

Incidence and Risk Factors of Parastomal Hernia in Patients With Permanent Colostomy in China

Beijing Friendship Hospital2 个研究点 分布在 1 个国家目标入组 712 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
712
试验地点
2
主要终点
Incidence of parastomal hernia

研究概览

简要总结

Parastomal hernia refers to the protrusion of the area around the stoma or the ectopic protrusion of abdominal contents from the stoma (colostomy, ileostomy, ileostomy for bladder) in the abdominal wall defect. Parastomal hernia is one of the common complications after permanent colostomy. According to guidelines published by the European Hernia Society, the overall incidence of parastomal hernia is unknown, but it can be predicted to be over 30% at 12 months, over 40% at 2 years, and over 50% at longer follow-up periods. Parastomal hernia may have no obvious symptoms at the beginning or only protrusion around the stoma. However, with the progression of the disease, the protrusion site may gradually increase, resulting in leakage, skin ulcers, perforation, incarceration, obstruction, strangulation and other serious complications. It will seriously affect the quality of life of patients and increase the medical burden and cost.

Risk factors related to parastomal hernia are currently considered to be mainly related to the patient's own factors and surgical factors. Studies have shown that female, old age, obesity, cardiopulmonary diseases, diabetes, long-term use of cortisol and other factors can increase the incidence of parastomal hernia in patients . Methods of stoma including extraperitoneal stoma, appropriate aperture of stoma and preventive mesh placement can reduce the incidence of parastomal hernia in patients.

In this study, patients with permanent colostomy and relevant information of surgery as well as the current incidence of parastomal hernia will be retrospectively collected in some high-level and high-volume tertiary hospitals in China. This study will be helpful to provide data reference for subsequent studies in this field.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • permanent colostomy after colorectal surgery for benign or malignant diseases
  • No previous colostomy history

排除标准

  • No CT scan follow-up at 1 year after surgery
  • Another ileocolonic diversion was performed except for the cause of parastomal hernia

结局指标

主要结局

Incidence of parastomal hernia

时间窗: 1 year after permanent colostomy

次要结局

  • risk factors of parastomal hernia(1 year after permanent colostomy)
  • Incidence of parastomal hernia(5 year after permanent colostomy)
  • classification of parastomal hernia(1 year after permanent colostomy)

研究者

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

Zhongtao Zhang

professor

Beijing Friendship Hospital

研究点 (2)

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