Colonic Resection, stOma, or Self-expandable Metallic Stent for obstruCtive Left cOlon Cancer. The CROSCO-1 Multicenter, Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 434
- 主要终点
- Stoma rate at 1 year after tumor resection
研究概览
简要总结
CROSCO-1 study is a national, multi-center, prospective observational study presenting patients to the emergency departments of the participating centers with obstructive left colon cancer (in the absence of metastases and peritoneal carcinomatosis) undergoing primary surgical tumor resection with a primary colorectal anastomosis (associated or not with a diverting loop ileostomy) or without a primary anastomosis ("Hartmann's procedure") or staged resection after endoscopic stenting with Self-expandable Metallic Stent (SEMS).
The main questions it aims to answer are:
- the Stoma rate at 1 year after tumor resection
- the 30-day and 90-day major morbidity and mortality
- 1-year quality of life (EQ-5D-5L test)
- Timing of chemotherapy initiation and type of chemotherapy regimen. Participants will have an obstructive left colon cancer localized (no peritoneal carcinosis or distant metastasis).
Researchers will compare: primary surgical tumor resection with a primary colorectal anastomosis (associated or not with a diverting loop ileostomy) or an "Hartmann's procedure" with a staged resection after endoscopic stenting with SEMS.
详细描述
Since surgical and oncological outcomes of the different treatment strategies for obstructing left colon cancers have not been studied on a large scale globally, we launched the CROSCO-1 study intending to compare the clinical results of all these therapeutic regimens in a cohort of patients treated for obstructive left-sided colorectal cancer (CRC).
The primary aim of the CROSCO-1 (Colonic Resection, stOma or self-expanding metal Stents for obstruCtive left cOlon cancer) study is to describe the outcomes of the management of emergency presentations of obstructive left CRC with colorectal resection with or without primary anastomosis versus the staged approach with SEMS insertion and subsequent colorectal resection. The primary aim of the CROSCO-1 study will be the 1-year stoma rate of patients undergoing primary emergency surgical resection (Hartmann procedure or primary resection and anastomosis) compared with patients undergoing staged resection (emergency endoscopic treatment with SEMS followed by elective resection). Other outcomes will be 30-day and 90-day major morbidity and mortality, 1-year quality of life, and the timing and type of chemotherapy initiation in the two groups.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes, ≥ 18 years old.
- •Patients with abdominal CT scan diagnosis of colonic obstruction due to obstructive left colonic cancer (sigmoid or descending colon).
- •Absence of distant metastases on abdominal and chest CT scan.
- •Patients who may face a one-year follow-up.
- •Patients fit for surgery.
- •Patients with colonic adenocarcinoma on postoperative histological examination.
排除标准
- •Right-side or trasverse colon cancer.
- •Surgical or endoscopic palliation in patients with peritoneal carcinomatosis, locally advanced Colorectal cancer (CRC) (T4 sec. TNM), M1 disease.
- •Bowel obstruction determinated by other tumors or benign inflammatory stenosis.
- •Concomitant bowel abscess, perforation, or fistula.
- •Elective procedures.
- •Pregnancy or lactation.
结局指标
主要结局
Stoma rate at 1 year after tumor resection
时间窗: 1 year
the number of stomas after 1 year of primary surgery with tumor resection
次要结局
- 1-year quality of life (The 5-level EQ-5D version (EQ-5D-5L)test)(1-year)
- Timing of chemotherapy initiation(2-years)
- type of chemotherapy regimen(2-years)
- 30-day and 90-day major morbidity(30-days; 90-days)
- 30-day and 90-day mortality(30-days; 90-days)
研究者
Alessio Giordano
Principal Investigator
Azienda Sanitaria di Firenze