Robotic Transanal Specimen Extraction Surgery Versus Robotic Transabdominal Incision Specimen Extraction Surgery for Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 556
- 试验地点
- 12
- 主要终点
- Complication rate
研究概览
简要总结
This prospective, multicenter, randomized, open-label study aims to evaluate the perioperative safety and feasibility of specimen extraction through anus regarding robotic radical excision of rectal cancer.
详细描述
In this study, investigators will evaluate the perioperative safety and feasibility of robotic transanal specimen extraction surgery with robotic transabdominal incision specimen extraction surgery as a control.The study is prospective, randomized, open-label, and multicenter conducted at 12 centers. Considering the significance level and abscission rate, it is expected that a total of 556 subjects will be included in the two groups from January 2023 to June 2024, with the incidence of postoperative complications as the main study endpoint.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 to 75 years;
- •Historically confirmed rectal adenocarcinoma;
- •Diagnosed with rectal cancer by pelvic/rectal magnetic resonance imaging;
- •cT1-4aNxM0 high rectal adenocarcinoma; cT1-3NxM0 mid/low rectal adenocarcinoma;
- •No evidence of distant metastases;
- •A maximum of 5cm in diameter;
- •Body mass index (BMI) ≤ 30 kg / m2;
- •No local complications (no obstruction, incomplete obstruction, no massive active bleeding, no perforation, preoperatively abscess formation, no local invasion);
- •Willing to undergo surgery;
- •Sign the informed consent;
排除标准
- •Presence of lateral/inguinal lymph node metastases;
- •Previous history of malignant colorectal tumor;
- •Multiple primary colorectal tumors;
- •Neoadjuvant therapy;
- •Salvage surgery for endoscopic surgery;
- •History of previous abdominopelvic surgeries or extensive intra-abdominal adhesion;
- •Familial adenomatous polyposis, Lynch syndrome, and inflammatory bowel disease;
- •Comorbid with other malignancies within 5 years;
- •ASA ≥ IV and/or ECOG performance status score ≥ 2;
- •Severe liver, kidney, cardiopulmonary insufficiency, coagulopathy or serious underlying diseases;
- •Serious mental illness;
- •Pregnant or lactating women;
- •Uncontrolled infection;
- •Abnormal anal function or anal stenosis;
结局指标
主要结局
Complication rate
时间窗: Up to 30 days postoperatively.
Complication rate within 1 month postoperatively.All complications of surgery will be documented and graded by the Clavien-Dindo classification system,generally including anastomotic leakage, abdominal infection, bleeding, incision infection, incision implantation, intestinal obstruction, and rectovaginal fistula.
次要结局
- LARS scale(1 day before operation, and 1, 3, 6 months postoperatively.)
- EORTC QLQ-C30(1 day before operation, 1, 3, 6 months postoperatively.)
- C-reactive protein (CRP)(1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.)
- Positive rate of tumor cells(Intraoperative.)
- Tumor size(Up to 30 days postoperatively.)
- Distance , positive condition of pathological margin (proximal, distal, circumferential)(Up to 30 days postoperatively.)
- Overall survival rate(1, 3, 5 years postoperatively.)
- Number of Histopathological type(Up to 30 days postoperatively.)
- Postoperative recovery composite(Up to 2 weeks.)
- EORTC QLQ-C38(1 day before operation, 1, 3, 6 months postoperatively.)
- Interleukin(1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.)
- CD3, CD4, and CD8 lymphocyte subsets(1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.)
- Degree of differentiation(Up to 30 days postoperatively.)
- Hospitalization costs(Up to 30 days.)
- Cortisol(1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.)
- Pain assessment(1 day before operation, 1, 2, 3 days postoperatively, and up to 2 weeks.)
- bacterial positive rate(Intraoperative.)
- Wexner scale(1 day before operation, and 1, 3, 6 months postoperatively.)
- Local recurrence rate(1, 3, 5 years postoperatively.)
- Number of lymph node dissection and metastasis(Up to 30 days postoperatively.)
- Nerve vessel involvement rate(Up to 30 days postoperatively.)
- The incidence rate of distant metastasis(1, 3, 5 years postoperatively.)
- Tumor-free survival rates(1, 3, 5 years postoperatively.)
研究者
Taiyuan Li
Professor
The First Affiliated Hospital of Nanchang University