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临床试验/DRKS00013997
DRKS00013997已完成未知

Ghost-ileostomy versus conventional loop ileostomy in patients undergoing low anterior resection for rectal cancer – the GHOST-trial - GHOST

Klinik für Allgemein-, Viszeral- und Transplantationschirurgie0 个研究点目标入组 30 人开始时间: 2018年4月9日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
30

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • Patients undergoing elective low anterior resection for rectal cancer
  • - Ability of subject to understand character and individual consequences of the clinical trial
  • - = 18 years of age
  • - Written informed consent

排除标准

  • Preoperative exclusion criteria:
  • - BMI >30 kg/m²
  • - Chronic renal failure (necessitating dialysis or GFR <30 ml/min)
  • - Immunosuppression (cortisone = 40 mg/d or equivalent; azathioprine, etc.)
  • - Significant cardiac disease
  • - Current therapeutic anticoagulation
  • - Liver cirrhosis (of any Child-Pugh grade)
  • - Ultralow rectal cancer (<4 cm ab ano, or necessitating intersphincteric resection or transanal colo-anal anastomosis)
  • - Participation in another intervention trial with interference of intervention and outcome of this study
  • Intraoperative exclusion criteria:
  • - Incomplete stapling rings
  • - Positive intraoperative air (bubble) test
  • - Intraoperative findings that make a loop ileostomy inevitable in the individual surgeon’s opinion (e.g. intraoperative diagnosis of liver cirrhosis, acute or chronic Ileus, intraoperative lesion of the rectum, urinary bladder, vagina, etc.)
  • - Multivisceral resection

研究者

发起方
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie

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