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临床试验/NCT03560180
NCT03560180Unknown不适用

Early Diagnosis of Anastomotic Leakage After Colorectal Surgery: a Prospective Observational Validation Study of the Dutch Leakage Score, Serum Procalcitonin and Serum CRP: the Italian ColoRectal Anastomotic Leakage (iCRAL) Study Group.

Ospedale C & G Mazzoni18 个研究点 分布在 1 个国家目标入组 1,131 人开始时间: 2017年9月4日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,131
试验地点
18
主要终点
Anastomotic Leakage

研究概览

简要总结

Prospective evaluation of early diagnosis of anastomotic leak after colorectal resection through evaluation of Dutch leakage score, serum C-reactive protein and serum Procalcitonin

详细描述

BACKGROUND

Anastomotic leakage is a dreaded major complication after colorectal surgery. The overall incidence of anastomotic dehiscence and subsequent leaks is 2 to 7 percent when performed by experienced surgeons. The lowest leak rates are found with ileocolic anastomoses (1 to 3 percent) and the highest occur with coloanal anastomosis (10 to 20 percent). Leaks usually become apparent between five and seven days postoperatively. Almost half of all leaks occur after the patient has been discharged, and up to 12 percent occur after postoperative day 30. Late leaks often present insidiously with low-grade fever, prolonged ileus, and nonspecific symptoms attributable to other postoperative infectious complications. Small, contained leaks present later in the clinical course and may be difficult to distinguish from postoperative abscesses by radiologic imaging, making the diagnosis uncertain and underreported.

There is no uniform definition of an anastomotic dehiscence and leak. In a review of 97 studies, as an example, 56 different definitions of an anastomotic leak were used. The majority of reports define an anastomotic leak using clinical signs, radiographic findings, and intraoperative findings. The clinical signs include: Pain, Fever, Tachycardia, Peritonitis, Feculent drainage, Purulent drainage. The radiographic signs include: Fluid collections, Gas containing collections. The intraoperative findings include: Gross enteric spillage, Anastomotic disruption.

Risk factors for a dehiscence and leak are classified according to the site of the anastomosis (extraperitoneal or intraperitoneal). A prospective review of 1598 patients undergoing 1639 anastomotic procedures for benign or malignant colorectal disease found a significantly increased risk of anastomotic leak with extraperitoneal compared with intraperitoneal anastomoses (6.6 versus 1.5 percent; 2.4 percent overall).

Major risk factors for an extraperitoneal anastomotic leak include: The distance of the anastomosis from the anal verge (Patients with a low anterior resection and an anastomosis within 5 cm from the anal verge are the highest risk group for an anastomotic leak), Anastomotic ischemia, Male gender, Obesity.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients submitted to laparoscopic/robotic/open/converted ileo-colo-rectal resection with anastomosis (both intra- and/or extra-corporeal), including planned Hartmann's reversals.
  • American Society of Anesthesiologists' (ASA) class I, II or III
  • Elective surgery
  • Patients' written acceptance to be included in the study.

排除标准

  • American Society of Anesthesiologists' (ASA) class IV-V
  • Patients with stoma before or at operation
  • Simple stoma closure
  • Transanal procedure
  • Ongoing infection prior to surgery
  • Hyperthermic intraperitoneal chemotherapy for carcinomatosis

结局指标

主要结局

Anastomotic Leakage

时间窗: 60 days after operation

Main outcome is anastomotic dehiscence (intended as any deviation from the planned postoperative course related to the anastomosis, or presence of pus or enteric contents within the drains, presence of abdominal or pelvic collection in the area of the anastomosis on postoperative CT scan, performed at the discretion of the attending surgeon, leakage of contrast through the anastomosis during enema or evident anastomotic dehiscence at reoperation for postoperative peritonitis). Thus, all detected leaks will be considered independently of clinical significance. No imaging will be performed routinely in order to search for leakage.

次要结局

  • Operative morbidity rates(60 days after operation)
  • Postoperative length of stay(60 days after operation)
  • Operative mortality rates(60 days after operation)

研究者

发起方
Ospedale C & G Mazzoni
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Catarci

Director, General Surgery Unit

Ospedale C & G Mazzoni

研究点 (18)

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