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临床试验/NCT00940030
NCT00940030已完成不适用

Effect of Mechanical Bowel Preparation With Polyethylene Glycol Plus Bowel Enema (Glycerine 5%) vs Bowel Enema Alone in Patients Candidates to Colorectal Resection for Malignancy. Prospective, Randomized Clinical Trial

European Institute of Oncology2 个研究点 分布在 1 个国家目标入组 440 人开始时间: 2007年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
440
试验地点
2
主要终点
Anastomotic leakage, wound infection (including deep abscess)

研究概览

简要总结

The purpose of this study is to evaluate mechanical bowel preparation (MBP) with polyethylene glycol plus bowel enema versus bowel enema alone in patients candidates to colorectal resection for malignancy.

详细描述

Surgical site infections (SSI) in colorectal surgery (anastomotic leakage, wound infection, intraabdominal abscess) are associated with increased mortality, postoperative hospital stay and costs. From a recent metanalysis and randomized clinical trial there is the emerging evidence that mechanical bowel preparation (MBP) before elective colorectal surgery is not associated with reduction of SIS, although it causes high discomfort for patients. On the same way other more recent studies show that MBP may cause an higher incidence of SIS, and that MBP may alter the bowel mucosa morphology. Other Authors report an increased incidence of anastomotic leakage requiring surgery for patients undergoing a single preoperative phosphate enema whereas but an higher cardiovascular mortality for patients undergoing MBP. Two recent studies do not clarify the usefulness of MBP for reducing SIS after colorectal surgery and one stage anastomosis. For these reasons a more precise understanding of the relationship between MBP and SIS could increase patients satisfaction and decrease unnecessary procedures and costs. At this point MBP represent the clinical standard for patients undergoing elective colorectal surgery at the European Institute of Oncology.

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
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients candidates to colorectal surgery for histologically confirmed colorectal cancer
  • Age 18-80 years
  • Obtained written consent

排除标准

  • Patients at high risk for receiving a stoma (e. g. patients affected by distal rectal cancer <5cm from the anal verge; patients whose tumour is located >5 cm from the anal verge who underwent neoadjuvant CT-RT without downstaging or tumour shrinkage
  • Intestinal obstruction
  • Emergency procedures
  • Patients who underwent colonoscopy within 7 day from surgery
  • ASA 4-5 patients
  • Patients unable to give informed consent
  • Renal failure (serum creatinine >3 mg/dl)
  • Pregnant women
  • Breast feeding women

研究组 & 干预措施

MBP+enema

Experimental

mechanical bowel preparation and enema

干预措施: mechanical bowel preparation (Other)

MBP+enema

Experimental

mechanical bowel preparation and enema

干预措施: enema (Other)

enema

Active Comparator

干预措施: enema (Other)

结局指标

主要结局

Anastomotic leakage, wound infection (including deep abscess)

时间窗: 30 days after surgery

次要结局

  • post surgery extra abdominal complications(30 days)
  • patient's symptoms (through questionaire)(30 days)

研究者

发起方
European Institute of Oncology
申办方类型
Other
责任方
Sponsor

研究点 (2)

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