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临床试验/NCT03856671
NCT03856671已完成不适用

Prophylatic Effect of Preoperative Antibiotics With Mechanical Bowel Preparation Compare With Simple Mechanical Bowel Preparation Before Laparoscopic Colorectal Surgery: a Randomized Controlled Trial

Third Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 309 人开始时间: 2019年1月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
309
试验地点
1
主要终点
Surgical site infection incidence

研究概览

简要总结

Surgical site infection (SSI) is a major postoperative complication after abdominal surgery especially in colorectal field, which significantly increases length of stay (LOS), readmission incidence and expense. Therefore, identification of the effective method to reduce SSI incidence is critically important. Combination of oral antibiotics and mechanical bowel preparation was reported with lower SSIs and LOS in some retrospecitve data analysis, however a prospective randmized controlled trial was absent. Herein, the current randomized controlled trial comparing MBP+OA with MBP alone in postoperative complications in order to guide clinical practise was conducted.

详细描述

Surgical site infection (SSI) is a major postoperative complication after abdominal surgery especially in colorectal field, which significantly increases length of stay (LOS), readmission incidence and expense. Therefore, identification of the effective method to reduce SSI incidence is critically important. Colonic bacterial flora is the major cause of SSIs after elective colorectal procedures. For more than century, preoperative mechanical bowel preparation (MBP) has been utilized as it could theoretically decrease bacterial load within the surgical field, thus reduce risk of SSIs. Later afterwards with widely application of antibiotics, combination of oral antibiotics (OA) and MBP was conducted by surgeons to further decrease rates of SSIs. But SSIs still occurs despite of forehead mentioned methods, the best bowel preparation mode remains controversial. Since 2005, several RCTs and meta-analysises demonstrated MBP alone was not associated with reduced SSIs compared with no bowel preparation, while postoperative ileus, anastomotic leakage and other complications incidence increased paradoxically. Nevertheless, function of preoperative oral antibiotics remains debated. Recently, combination of oral antibiotics and MBP has been evaluated in several retrospective studies and demonstrated a significant decrease in the rate of SSIs. However, bias existence in these trials may affect result as information was exacted from national database without detailed matching. Herein, current randomized controlled trial comparing MBP+OA with MBP alone in postoperative complications in order to guide clinical practise was conducted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

No masking is to conducted in the current study.

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

  • Older than 18 years old,
  • Undergoing laparoscopic colorectal surgery due to malignancy.

排除标准

  • No elective surgery
  • Intra-abdominal infection
  • Combination of other infectious surgery such as appendectomy, cholecystomy
  • Sever comobidity such as uncontrolled hypertention and diabetes mellitus
  • Peritoneal implantation and matastasis
  • Radiotherapy history.
  • Colorectal surgery due to benign lesions
  • Allergic to antibiotics or PEG
  • Preoperative dermatosis may interfere wound healing
  • Long time application of corticosteroid
  • Autoimmune disease may affect wound healing
  • Patients refuse to enroll

研究组 & 干预措施

oral antibiotics+mechanical bowel preparation

Experimental

Liquid diet and polyethylene glycol with 2L water was administrated orally 1 day before surgery. A combination of neomycin 1g and metronidazole 0.2g every 6 hours was also administrated. Enteroclysis was conduted for patients on surgical morning.

干预措施: Neomycin,metronidazole (Drug)

结局指标

主要结局

Surgical site infection incidence

时间窗: 30 days after surgery

Include the superficial, deep and organ space infection.

次要结局

  • Antibiotics associated complications(30 days after surgery)
  • Length of hospital stay after surgery(30 days after surgery)
  • Bowel recovery time(7 days after surgery)
  • Other posteroperative complications(30 days after surgery)

研究者

发起方
Third Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hongbo Wei

Professor

Third Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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