Betacyanin for Early Diagnosis and Recovery of Anastomotic Leakage After Rectal Cancer Surgery: A Single-Center, Prospective, Controlled Trial
2026年7月21日 更新者：Tang Bo、Southwest Hospital, China
A Single - Center, Prospective,Controlled Clinical Trial Exploring the Function of Betacyanin in the Early Diagnosis and Subsequent Recovery From Anastomotic Leakage After Rectal Cancer Surgery
This single-center, prospective, controlled trial compares betacyanin versus conventional methods for early diagnosis and healing assessment of anastomotic leakage after rectal cancer surgery.
研究概览
研究类型
介入性
注册 (估计的)
120
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Bo Tang, MD
- 电话号码：+8613883902288
- 邮箱：2211934029@qq.com
研究联系人备份
- 姓名：Qi Zhang
- 电话号码：+8613508876528
- 邮箱：502384305@qq.com
学习地点
-
-
Chongqing Municipality
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Chongqing、Chongqing Municipality、中国、400030
- General Surgery Center of PLA
-
接触：
- Bo Tang, MD
- 电话号码：+8613883902288
- 邮箱：2211934029@qq.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Pathologically confirmed rectal adenocarcinoma prior to surgery.
- Undergoing laparoscopic anterior resection for rectal cancer.
- No prophylactic diverting ileostomy.
- American Society of Anesthesiologists (ASA) Physical Status Classification ≤ 3.
- No prior history of malignant tumors, and no evidence of other malignancies on preoperative examination.
- Written informed consent obtained from the patient or a legally authorized representative.
Exclusion Criteria:
- Prior abdominal surgery with severe intra-abdominal adhesions.
- Currently participating in, or having participated within the past 6 months in, another clinical study related to rectal cancer surgery.
- Preoperative complications requiring emergency surgery, including bleeding, perforation, or obstruction.
- History of prior malignancy.
- Undergoing Parks procedure with anastomosis at the anal verge, or Miles procedure, or Hartmann's procedure.
- Preoperative neoadjuvant chemoradiotherapy, or presence of other high-risk factors for anastomotic leakage requiring a prophylactic diverting ileostomy.
- ASA Physical Status Classification > 3.
- Patient withdrawal of consent.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Betacyanin + Conventional Monitoring
All eligible patients who undergo rectal cancer resection will receive the same intervention and monitoring protocol.
Starting from postoperative day 3, each patient will orally consume 200 mL of betacyanin solution daily (concentration and formulation as specified in the study protocol).
Concurrently, pelvic drainage fluid will be collected daily to measure betacyanin concentration as a potential biomarker for early detection of anastomotic leakage.
In parallel, conventional diagnostic methods for anastomotic leakage-including clinical symptom assessment, routine laboratory tests (e.g., white blood cell count, C-reactive protein), and imaging studies when clinically indicated-will be performed on the same patients at the same time points.
Thus, each patient serves as his/her own control, allowing a direct comparison of diagnostic accuracy and healing evaluation between betacyanin-based monitoring and conventional approaches.
The intervention and monitoring will continue daily until h
|
200 mL oral betacyanin solution administered daily from postoperative day 3 until discharge or confirmation of anastomotic leakage
Daily measurement of betacyanin concentration in pelvic drainage fluid for early detection of anastomotic leakage
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Time to Diagnosis of Anastomotic Leakage
大体时间：Within 30 days after surgery
|
Within 30 days after surgery
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Diagnostic Performance of Betacyanin for Anastomotic Leakage
大体时间：Within 30 days after surgery
|
Within 30 days after surgery
|
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Time to Healing of Anastomotic Leakage
大体时间：Within 30 days after surgery
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Within 30 days after surgery
|
|
Incidence of Postoperative Grade III-IV Complications
大体时间：Within 30 days after surgery
|
Within 30 days after surgery
|
|
Reoperation Rate
大体时间：Within 30 days after surgery
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Within 30 days after surgery
|
|
Length of Postoperative Hospital Stay
大体时间：From surgery to hospital discharge, assessed up to 30 days
|
From surgery to hospital discharge, assessed up to 30 days
|
|
30-Day Readmission Rate
大体时间：Within 30 days after hospital discharge
|
Within 30 days after hospital discharge
|
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Cost of Anastomotic Leakage Diagnosis
大体时间：During index hospitalization, assessed up to 30 days
|
During index hospitalization, assessed up to 30 days
|
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Total Hospitalization Cost
大体时间：During index hospitalization, assessed up to 30 days
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During index hospitalization, assessed up to 30 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月20日
初级完成 (估计的)
2027年5月1日
研究完成 (估计的)
2027年5月31日
研究注册日期
首次提交
2026年7月21日
首先提交符合 QC 标准的
2026年7月21日
首次发布 (实际的)
2026年7月27日
研究记录更新
最后更新发布 (实际的)
2026年7月27日
上次提交的符合 QC 标准的更新
2026年7月21日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- TBo20251116
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.