A Comparative Study of Clinical Outcomes Between Leak Testing and No Leak Testing for Anastomosis in Colorectal Cancer Surgery: a Multicenter, Stratified Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Number of Participants with Anastomotic Leak within 30 days
研究概览
简要总结
To evaluate the effectiveness of the gastroscopy, air, and methylene blue (GAM) leak testing in reducing the incidence of postoperative anastomotic complications, especially anastomotic leakage, in patients with colorectal cancer. The primary outcomes included is the incidence of anastomotic complications (mainly anastomotic leak) within 30 days after surgery
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with colorectal cancer by pathology and scheduled for surgical treatment who meet the surgical indications.
- •Aged between 18 and 85 years.
- •American Society of Anesthesiologists (ASA) physical status classification is I - III.
- •The patient or his/her legal representative can understand and sign the informed consent form and is willing to cooperate throughout the study process.
排除标准
- •Patients with preoperatively diagnosed anastomotic leak or other severe abdominal infections.
- •Patients with severe cardiovascular and cerebrovascular diseases (such as recent myocardial infarction, unstable angina pectoris, severe heart failure, acute cerebral infarction, etc.) who cannot tolerate surgery and related tests.
- •Patients with severely impaired liver and kidney function (liver function Child - Pugh classification C or above, creatinine clearance rate < 30 ml/min).
- •Patients with coagulation disorders (such as platelet count < 50×10⁹/L, international normalized ratio (INR) > 1.5, etc.) that cannot be corrected or are receiving anticoagulant therapy that cannot be adjusted.
- •Patients with a history of abdominal radiotherapy or multiple abdominal surgeries and severe abdominal adhesions that may affect the operation and detection procedures.
- •Patients with other malignant tumors who are receiving active anti-tumor treatment such as radiotherapy and chemotherapy.
- •Patients with mental illness or cognitive impairment who cannot cooperate with the study process and follow-up.
研究组 & 干预措施
≤5cm Rectal, Pre-chemo, Leak Test
Patients with rectal cancer ≤ 5 cm from the anus, received preoperative chemotherapy and intraoperative leak testing.
干预措施: Intraoperative leak testing (Procedure)
≤5cm Rectal, Pre-chemo, No Leak Test
Patients with rectal cancer ≤ 5 cm from the anus, received preoperative chemotherapy, and had no intraoperative leak testing.
≤5cm Rectal, No pre-chemo, Leak Test
Patients with rectal cancer ≤ 5 cm from the anus, didn't receive preoperative chemotherapy, and underwent intraoperative leak testing.
干预措施: Intraoperative leak testing (Procedure)
≤5cm Rectal, No pre-chemo, No Leak Test
Patients with rectal cancer ≤ 5 cm from the anus, didn't receive preoperative chemotherapy, and had no intraoperative leak testing.
>5cm Colorectal, Pre-chemo, Leak Test
Patients with colorectal cancer > 5 cm from the anus, received preoperative chemotherapy, and underwent intraoperative leak testing.
干预措施: Intraoperative leak testing (Procedure)
>5cm Colorectal, Pre-chemo, No Leak Test
Patients with colorectal cancer > 5 cm from the anus, received preoperative chemotherapy, and had no intraoperative leak testing.
>5cm Colorectal, No pre-chemo, Leak Test
Patients with colorectal cancer > 5 cm from the anus, didn't receive preoperative chemotherapy, and underwent intraoperative leak testing.
干预措施: Intraoperative leak testing (Procedure)
>5cm Colorectal, No pre-chemo, No Leak Test
Patients with colorectal cancer > 5 cm from the anus, didn't receive preoperative chemotherapy, and had no intraoperative leak testing.
结局指标
主要结局
Number of Participants with Anastomotic Leak within 30 days
时间窗: 30 days
Count the number of participants who develop anastomotic leak within 30 days after colorectal cancer surgery.
次要结局
- Number of Participants with Postoperative Complications within 30 days(30 days)