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临床试验/NCT01033838
NCT01033838招募中2 期

Conventional Laparoscopic-assisted Rectosigmoid Resection Versus Laparoscopic Rectosigmoid Resection With Intracorporeal Anastomosis and Transrectal Specimen Retrieval

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2009年12月最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
入组人数
1
试验地点
2
主要终点
Reduction in analgetic need

研究概览

简要总结

Laparoscopic anterior resection is a standardized procedure requiring a small muscle split incision to retrieve the specimen and to fashion the proximal part of the double stapled anastomosis. Most patients can be included within a standardized perioperative care program called Enhanced Recovery After Surgery (ERAS). A new evolution as a primary step towards a complete Natural Orifice Translumenal Endoscopic Surgery (NOTES)-procedure is a hybrid approach (transrectal and laparoscopic). The dissection is performed laparoscopically but the specimen is retrieved within an endobag through the rectum. The anastomosis is created intracorporeally using a triple stapled technique. There are no trials available in the literature concerning these 2 techniques. Therefore this study will be undertaken to establish the role of the 2 surgical procedures and to compare them after short-term follow-up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-90
  • Symptomatic recurrent diverticular disease
  • Benign adenomatous polyp, requiring surgery
  • Early non-transmural sigmoidtumor
  • Signed written informed consent, approved by ethical committee

排除标准

  • Patients unsuitable for laparoscopy
  • Pregnancy
  • ASA >III
  • Coagulation disorders
  • Anti-coagulants

结局指标

主要结局

Reduction in analgetic need

次要结局

  • reduction in hospital stay within an ERAS-program
  • effect on the inflammatory response
  • effect on anal continence
  • procedural cost assessment (incorporating operative time)
  • overall cost assessment

研究者

申办方类型
Other

研究点 (2)

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