Natural Orifice Specimen Extraction Surgery for Colorectal Cancer (NOSE for CRC)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 318
- 主要终点
- C-reactive protein (CRP) level
研究概览
简要总结
The goal of this type of study: a prospective, randomized controlled clinical trial is to assess the safety and feasibility of NOSE surgery to compare the NOSE and conventional laparoscopy groups in Colorectal cancer patients. The main questions it aims to answer are measuring the postoperative inflammatory response and monitoring the early morbidity and mortality rate after surgery. Participants will be assigned patients to undergo either NOSE surgery or conventional laparoscopic mini-laparotomy resection. If there is a comparison group: Researchers will compare the control group to see if postoperative inflammatory response.
详细描述
Endpoints (Outcome measure)：
Primary endpoint:
The primary outcome measure was the postoperative inflammatory response, which was evaluated by monitoring the C-reactive protein (CRP) level during hospitalization on the 3rd day following surgery. Early morbidity and mortality rate (postoperative 30 days): The early morbidity and mortality rate is defined as the event observed during the operation and within 30 days after surgery. Postoperative 30-day hospital readmission data will be also collected.
- Secondary endpoints:
A. Duration of Operation time: The length of the surgery will be recorded. B.Peritoneal Cytologyduring surgery: The investigators assess the tumor cells identified by peritoneal cytologic specimens. Given the relationship of positive cytology with metachronous peritoneal seeding, it is essential to evaluate datasets from patients who undergo the NOSE group.
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
- Single (Investigator)
盲法说明
Randomization assignment is performed by the statisticians of the clinical trial center to generate random codes.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Enrollment Histological or cytological confirmation of colorectal adenocarcinoma. Inclusion criteria
- •Performance status of 0 - 2 on the ECOG (Eastern Cooperative Oncology Group) scale
- •American Society of Anesthesiology (ASA) score is Ⅰ-Ⅲ
- •Tumor location: CRC with the lower margin of the tumor greater than 10 cm from the anal verge
- •Pre-operative T staging: T0-T4a at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
- •Preoperative M staging: M0 according to AJCC 8th
- •Tumor size: 4 cm or less
- •Written informed consent for participation
排除标准
- •Not suitable for minimally invasive surgery
- •Body mass index (BMI) >30 kg/m2
- •Malnutrition: albumin level less than 3.5
- •Previous pelvic surgery
- •Emergency surgery
结局指标
主要结局
C-reactive protein (CRP) level
时间窗: 3 minutes
The primary outcome measure was the postoperative inflammatory response, which was evaluated by monitoring the C-reactive protein (CRP) level during hospitalization on the 3rd day following surgery. Complete blood cell count and differential count, C-reactive protein, procalcitonin, and interleukin-6 will be measured on day 3 postoperatively
次要结局
- Duration of Operation time(60~90 minutes)
- Peritoneal Cytology during surgery(3 minutes)
- Peritoneal Contamination during surgery(3 minutes)
- Postoperative Pain Score(3 minutes)
- Postoperative Recovery course:(1 to 5 days)