A Prospective, Multicenter, Randomized Controlled Study Comparing Effect of Conventional Versus SIS-Reinforced Rectum Anastomosis On Anastomotic Leak Following Radical Resection of Mid-to-Low Rectal Cancer（SISReal）
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 966
- 试验地点
- 1
- 主要终点
- Rate of anastomotic leak within 30 days post-surgery
研究概览
简要总结
The goal of this clinical trial is to learn whether using a reinforcing material called SIS (small intestinal submucosa) during bowel connection after rectal cancer surgery can help prevent anastomotic leakage-a serious complication where the connection between two parts of the intestine fails to heal properly. This study will focus on patients with mid-to-low rectal cancer who are scheduled for surgery.
The main questions the study aims to answer are:
Does using an SIS-reinforced connection reduce the rate of anastomotic leakage within 30 days after surgery compared to standard connection methods?
Does it also reduce the need for a temporary stoma (an opening in the abdomen for waste removal)?
Researchers will compare two groups:
Intervention group: Patients who receive the SIS-reinforced connection during surgery.
Control group: Patients who receive the standard connection without reinforcement.
Participants in this study will:
Be randomly assigned to either the intervention or control group.
Undergo standard laparoscopic or robot-assisted rectal cancer surgery.
Be followed up at 30 days, 90 days, and 12 months after surgery to check for complications, stoma status, and quality of life.
This study is being conducted across multiple hospitals in China to ensure the results are reliable and widely applicable.
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
- — 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≤ 85 years old, regardless of gender.
- •Patients with mid - low rectal cancer, where the lower edge of the cancer focus is ≤ 10 cm from the anus and who can undergo rectal anastomosis with a circular stapler (including mid - low and some ultra - low rectal anastomoses). This includes patients after neoadjuvant therapy, patients with insufficient function of important organs such as the heart, liver, and kidneys who can tolerate surgery, and patients after intestinal obstruction stent placement or chemotherapy after intestinal obstruction stent placement.
- •For patients who, after being fully informed by doctors, still clearly refuse neoadjuvant therapy (for advanced rectal cancer) and/or immunotherapy (for MSI - H/dMMR rectal cancer) and request direct surgery, they are generally not included in this study. If a patient insists on enrolling, the operating surgeon must have a second conversation with the patient and/or their family members, and sign in the medical record to confirm the following: The patient is aware of the existence of the neoadjuvant therapy/immunotherapy pathway but refuses the relevant treatment and insists on direct surgery. Only in this case can the patient be allowed to enroll.
- •Patients who received conversion therapy due to distant organ (such as liver, lung) metastasis before surgery and then underwent surgery with primary anastomosis can be included in this study. If organ metastasis is accidentally found during surgery, or if the small intestine or bladder in the pelvic floor is invaded, but the surgeon believes it does not affect rectal anastomosis, the patient does not need to withdraw from the study.
- •The patient or their authorized representative voluntarily signs the informed consent form and can cooperate to complete the follow - up during the trial.
排除标准
- •Patients who, through examination and pre - operative consultation, cannot tolerate routine surgery.
- •Patients who are currently participating in other clinical studies.
- •Since the test device (SIS reinforcement patch) is derived from porcine - sourced materials, out of respect for specific religious beliefs (such as Islam), we do not recommend that subjects whose beliefs prohibit contact with porcine - sourced products participate in this study. We will fully communicate this situation with all potential subjects, and the subjects will make their own decisions based on their personal beliefs and cultural backgrounds.
- •Patients who do not meet the NCCN and the National Health Commission of China's treatment standards for rectal cancer will not be included in this study. For example, patients who should receive neoadjuvant therapy before surgery should preferentially choose neoadjuvant therapy, and MSI - H/dMMR patients are required to undergo immunotherapy first.
- •Due to the possible difficulty in matching the number of patients/omissions with regular patients, patients who require lateral lymph node dissection and those who receive Ta - TME will not be included in this study.
- •Patients who, due to language or intellectual disabilities, cannot understand the content of the trial protocol, cannot complete the follow - up, or for whom the researcher deems there are other situations that are not suitable for enrollment (such as uncontrolled severe underlying diseases, mental illness, etc.).
研究组 & 干预措施
Intervention arm
干预措施: SIS-reinforced anastomosis (Device)
control group
结局指标
主要结局
Rate of anastomotic leak within 30 days post-surgery
时间窗: From the date of surgery up to 30 days postoperatively.
The proportion of participants experiencing an anastomotic leak (AL) within 30 days after surgery. AL is defined as a defect in the integrity of the intestinal wall at the anastomosis site, leading to communication between the intra- and extraluminal compartments. Diagnosis is based on a combination of clinical signs (e.g., fever, abdominal pain, fecal discharge from drain), imaging findings (extravasation of contrast on enema CT scan or presence of peri-anastomotic fluid/air collections), or endoscopic evidence. Leaks are graded per the International Study Group of Rectal Cancer (ISREC) classification: Grade A (requiring no active therapeutic intervention), Grade B (requiring active therapeutic intervention but manageable without reoperation), and Grade C (requiring reoperation).
Rate of anastomotic leak within 30 days post-surgery
时间窗: From the date of surgery up to 30 days postoperatively
Proportion of participants with an anastomotic leak (AL) within 30 days post-surgery. AL is a defect in the intestinal wall anastomosis, confirmed by clinical signs (e.g., fever, fecal drain output), imaging (CT scan with contrast extravasation or peri-anastomotic collections), or endoscopy. Leaks are graded per International Study Group of Rectal Cancer (ISREC) criteria: Grade A (no intervention), B (managed without reoperation), or C (requires reoperation).
次要结局
未报告次要终点