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临床试验/NCT02500992
NCT02500992Unknown不适用

Bacterial Contamination in Transrectal Hybrid Natural Orifice Translumenal Endoscopic Surgery Sigmoidectomy for Diverticular Disease

Cantonal Hosptal, Baselland1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Peritoneal bacterial contamination

研究概览

简要总结

Transrectal Hybrid natural orifice translumenal endoscopic surgery sigmoidectomy has gained popularity. It is an appealing technique as a minilaparotomy in order to retrieve the specimen is avoided. Therefore less postoperative pain and a better cosmetic result are expected. The feasibility of the technique has been demonstrated.

Still an open question is the risk of intraperitoneal contamination as in this procedure the colon has to be opened. This is the case for (a) retrieval of the specimen thru the opened rectal stump and (b) for intracorporeal insertion of the anvil of the circular stapler in order to fashion an anastomosis.

In this study the bacterial contamination in the rectal stump as well as in the peritoneal cavity is assessed. The results are compared to bacteriological samples taken in a comparison group consisting of conventional laparoscopic assisted sigmoidectomies.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Status post several episodes of diverticulitis
  • Status post contained diverticulitis

排除标准

  • not able to give informed consent
  • <18 years of age
  • pregnancy
  • emergency operation
  • acute diverticulitis

结局指标

主要结局

Peritoneal bacterial contamination

时间窗: during surgery

microbacteriological swabs

Contamination in the rectal stump after wash-out

时间窗: during surgery

次要结局

  • septic complications(within 30 days after surgery)

研究者

发起方
Cantonal Hosptal, Baselland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Steinemann, MD

Consultant

Cantonal Hosptal, Baselland

研究点 (1)

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