Diagnostic and Preventive Strategies for Colorectal Anastomotic Leakage in Patients With Gynecologic Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 766
- 试验地点
- 1
- 主要终点
- To ascertain the sensitivity, specificity , positive predictive value and negative predictive value of the test to diagnose an anastomotic leak after colorectal resection during post-operative period
研究概览
简要总结
The main hypothesis is that anastomotic leakage can be predicted peri- and postoperatively.To this end, the aim is to establish the accuracy of transvaginal ultrasound with transrectal enema (Ecoenema-TV) for the diagnosis of anastomotic leakage in patients undergoing colorectal anastomosis.
diagnosis of anastomotic leakage in patients undergoing colorectal anastomosis.
详细描述
Cytoreductive surgery is the cornerstone of advanced ovarian cancer treatment and often requires the performance of a modified posterior pelvic exenteration (MPE) or colorectal resection (CRR), ideally followed by an end-to-end colorectal anastomosis with the goal of achieving optimal cytoreduction. One of the most challenging complications of this procedure is anastomotic leakage (AL) which is considered a life-threatening situation with a reported incidence between 1.24% and 9% in patients with ovarian cancer making any adjuvant postoperative treatment challenging and therefore having a negative impact on the overall prognosis.
In order to diagnose the presence of anastomotic leakage in female patients after colorectal anastomosis we devised this diagnostic test during the postoperative period.
The ECO-LEAK test is performed in the following sequence, after informing the patient and obtaining her consent. The patient is placed in gynaecological position/ lithotomy. Then basal transvaginal ultrasound is performed with the aim of describing the presence or absence of free fluid or other ultrasound findings (sagittal and transverse scan). Simultaneously transanal foley catheter is introduced and filled the balloon of the probe by direct visualization. Then transvaginal ultrasound with enema is performed with insertion of 180cc of serum under ultrasound vision with probe in vagina and sagittal and mid-sagittal cut. If no new free peri-anastomotic/pelvic fluid appears, the test is considered negative. If there is an appearance of pelvic free fluid (previously absent) or an increase in free fluid with respect to the baseline examination (fluid present at the beginning of the examination) peri anastomosis/pelvic, the test is considered positive.
In conclusions, anastomotic leak can occur despite a normal intraoperative anastomosis check-up. Transvaginal ultrasound associated with a transrectal enema (ECO-LEAK) performed during post operative period might represent an useful tool for anastomotic leak diagnosis. A prospective study is needed in order to determine its accuracy
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
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman sex
- •Age between 21-99 years old
- •Colorectal resection and anastomosis
- •Anastomosis upper from 5 cm from anal verge
- •Signed informed consent
排除标准
- •No colorectal anastomosis after resection
- •Ultralow colorectal anastomosis (< 5 cm)
- •Insufficient vaginal cuff for TV-US examination
结局指标
主要结局
To ascertain the sensitivity, specificity , positive predictive value and negative predictive value of the test to diagnose an anastomotic leak after colorectal resection during post-operative period
时间窗: 24 months
ECO-LEAK for anastomotic leakage diagnosis in women after colorectal resection and anastomosis
次要结局
未报告次要终点