A Prospective Single-arm Phase II Clinical Study Evaluating Local Methylene Blue Injection for Prevention of Anastomotic Leakage and Permanent Stoma in High-risk Patients With Rectal Cancer Undergoing Low Anterior Resection
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Proportion of participants with successful stoma closure within 12 months after surgery
研究概览
简要总结
Rectal cancer surgery has become increasingly effective, allowing many patients to avoid permanent colostomy. However, anastomotic leakage remains one of the most serious complications after rectal cancer surgery, especially in patients undergoing low anterior resection. Anastomotic leakage may lead to pelvic infection, prolonged hospitalization, additional treatments, and may affect the recovery of temporary diverting stomas.
This investigator-initiated clinical study aims to evaluate the safety and potential effectiveness of local methylene blue injection around the pelvic floor after completion of colorectal anastomosis in patients with high-risk rectal cancer undergoing low anterior resection with a temporary diverting ileostomy.
In this study, eligible patients will receive local injection of diluted methylene blue solution into the pelvic floor muscles surrounding the anastomosis after surgery. Participants will be followed for 12 months after surgery. The study will evaluate postoperative outcomes, including the occurrence of anastomotic leakage, complications related to the injection procedure, and whether the temporary stoma can be successfully reversed.
The information collected in this study may help determine whether local methylene blue injection is a safe and feasible approach for reducing postoperative complications and improving recovery after rectal cancer surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adults aged 18 years or older with histologically confirmed rectal adenocarcinoma.
- •Patients with mid or low rectal cancer (tumor located within 10 cm from the anal verge) who are scheduled to undergo curative low anterior resection with a temporary diverting ileostomy.
- •Patients with one or more risk factors associated with postoperative stoma non-closure or anastomotic complications, including male sex, narrow pelvis, neoadjuvant chemoradiotherapy, prolonged operative time, or increased intraoperative bleeding risk.
- •Patients who are considered suitable candidates for surgery and postoperative follow-up according to the investigator's assessment.
- •Patients who are willing to provide written informed consent.
排除标准
- •Patients with emergency surgical conditions, including intestinal obstruction, bowel perforation, or acute abdominal infection before surgery.
- •Patients undergoing abdominoperineal resection, local excision, or other surgical procedures without colorectal anastomosis and diverting ileostomy.
- •Patients with other active malignancies or recurrent rectal cancer. Patients who are unable to tolerate the planned surgery or follow-up procedures.
- •Patients with contraindications or known hypersensitivity to methylene blue injection.
- •Patients with severe medical conditions or laboratory abnormalities that may increase study-related risks or interfere with study outcome evaluation.
研究组 & 干预措施
Experimental
methylene blue injection
干预措施: methylene blue injection (Drug)
结局指标
主要结局
Proportion of participants with successful stoma closure within 12 months after surgery
时间窗: 12 months after surgery
Successful stoma closure is defined as reversal of the temporary diverting ileostomy within 12 months after low anterior resection. The outcome will be reported as the proportion of participants who undergo stoma closure among all enrolled participants.
次要结局
- Number of participants with postoperative surgical complications within 30 days after surgery(30 days after surgery)
- Number of participants with methylene blue-related adverse events within 30 days after surgery(30 days after surgery)