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临床试验/EUCTR2019-004840-30-IT
EUCTR2019-004840-30-IT进行中(未招募)1 期

Comparison of low-volume versus high-volume polyethylene glycol based bowel preparation for colonoscopy in people receiving hemodialysis: a randomized non-inferiority trial. - PrepDial

Policlinico di Bari-UO Gastroenterologia0 个研究点目标入组 264 人开始时间: 2020年10月21日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
264

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - age =18 years;
  • - prevalent end stage kidney disease treated with long-term hemodialysis (hemodialysis for at least 6 months; either hemodialysis or hemofiltration or hemodiafiltration, received for at least 3 times/week for a minimum duration of 4 hours per treatment session for a minimum of 12 hours/week, according to standard practice for quality hemodialysis in Italy);
  • - inpatients and outpatients with an indication to undergo colonoscopy (e.g. positive fecal occult blood test or fecal immunochemical test, signs or symptoms of colorectal disease, colorectal cancer screening, colorectal cancer surveillance, inflammatory bowel diseases, or inclusion in kidney transplantation waiting list);
  • - signature of written informed consent.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 264
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 264

排除标准

  • - end stage kidney disease not on hemodialysis (eg. peritoneal dialysis or kidney transplantation);
  • - previous kidney transplantation;
  • - need for colonoscopy in emergency;
  • - previous colorectal surgery;
  • - contraindications to colonoscopy in the opinion of the managing physician;
  • - pregnancy or breastfeeding;
  • - known or suspected hypersensitivity to any components of preparations.

研究者

发起方
Policlinico di Bari-UO Gastroenterologia

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