Postoperative and Long-term Outcomes of Transanal Tran-section and Single-stapled Anastomosis (TTSS) in Rectal Can-cer Patients: a Multicentric International IDEAL Stage 2b Prospective Parallel Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 472
- 试验地点
- 1
- 主要终点
- Rate of anastomotic leak
研究概览
简要总结
The Transanal Transection and Single-Stapled anastomosis (TTSS) technique may be a valid alternative to traditional double-stapled anastomosis for low rectal cancer surgery. This study aims to compare the postoperative and functional outcomes of patients receiving TTSS and traditional double-stapled anastomosis.
详细描述
The Transanal Transection and Single-Stapled anastomosis (TTSS) technique has become a valid alternative to the standard double-stapled anastomosis approach in the surgical treatment of low rectal cancer. Recent evidence showed a significantly reduced number of anastomotic leaks in patients undergoing TTSS compared with patients receiving double-stapled anastomosis, suggesting that TTSS may be technically feasible and may provide a surgical advantage over the traditional double-stapled technique. However, these studies were severely limited by their single-center and retrospective nature. This study aims to confirm the retrospective findings by extending the data collection to additional countries and provide prospective data collection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Adult (≥ 18 years old) patients, men and women, diagnosed with rectal cancer scheduled for elective rectal resection with Total Mesorectal Excision (TME) with double-stapled or Transanal Transection and Single-Stapled anastomosis (TTSS) approaches.
- •Patients scheduled for open, laparoscopic, or robotic surgery.
- •Patients preoperatively indicated for sphincter-saving procedures with or without protective-stoma.
排除标准
- •Immediate or delayed hand-sewn coloanal anastomosis.
- •Patients requiring abdominoperineal resection (APR). Patients undergoing unplanned non-reconstructive surgery will be withdrawn from the study.
- •Patients with concurrent or previous invasive pelvic malignant tumors. Patients with an intraoperative evidence of invasive pelvic malignant tumors will be withdrawn from the study.
结局指标
主要结局
Rate of anastomotic leak
时间窗: 90 days after surgery
Rate difference of clinical and/or radiological anastomotic leaks in the study cohorts.
次要结局
- Postoperative Recovery Profile (PRP) score(90 days after surgery)
- Low Anterior Resection Syndrome (LARS) score(24 months after surgery or stoma closure)
- Cancer recurrence(24 months after surgery)
- Proportion of patients fit for stoma closure(12 months after surgery)
- Rate of postoperative complications(90 days after surgery)
- Healthcare costs(12 months after surgery)