Transverse Colostomy for Refractory Hemorrhagic Chronic Radiation Proctitis With Moderate to Severe Anemia: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- remission rate of rectal bleeding after colostomy
研究概览
简要总结
Refractory rectal bleeding of chronic radiation proctitis (CRP) is still problematic and does not respond to medical treatments including reagents, endoscopic argon plasma coagulation (APC) or topical formalin. We proposed this prospective cohort study, to assess the efficacy and safety of colostomy in treating refractory hemorrhagic CRP with moderate to severe anemia, to provide higher-quality evidence of colostomy in these patients.
详细描述
Chronic radiation proctitis (CRP) is a common complication after radiotherapy of pelvic malignancies, accounting for 5%-20% of cases. Rectal bleeding is the most common symptom, which accounts for > 80% of CRP patients. Mild to moderate bleeding can be controlled by medical agents like sucralfate, endoscopic argon plasma coagulation (APC) or topical formalin. Severe and refractory bleeding is still problematic and refractory to these above medical treatments. Our previous retrospective study found that colostomy obtained a higher rate of bleeding remission (94% vs 12%) in 6 months, especially in control of transfusion-dependent bleeding (100% vs0%), when compared to conservative treatments.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically diagnosed with pelvic malignancies, including gynecologic, prostate, or urinary cancers;
- •History of pelvic radiation;
- •No tumor recurrence or metastasis;
- •Refractory hemorrhagic CRP;
- •Time of rectal bleeding >6 months;
- •SOBS=3 points;
- •severe anemia （Hb≤7 g/dl）or transfusion history for CRP bleedings.
排除标准
- •Severe complications of CRP, including deep ulcer or fistula, stricture, necrosis, refractory perianal pain;
- •Other hemorrhagic diseases, like III-IV degree hemorrhoids;
- •History of colon or rectum resection;
- •Intestinal obstruction and surgery needed;
- •with contraindications to general anaesthesia (ASA class 4 or 5);
- •pregnant or breast-feeding;
- •history of mental disorder.
结局指标
主要结局
remission rate of rectal bleeding after colostomy
时间窗: 6 mon after colostomy
retcal bleeding is assessed by soma scores
次要结局
- Anorectal function outcomes(baseline, 6 months, 1 year, 2 years, 3 years)
- endoscopic score(baseline, 6 months, 1 year, 2 years, 3 years)
- Quality of life by EORTC scores(baseline, 6 months, 1 year, 2 years, 3 years)
- Remission rate of rectal bleeding(1 year, 2years, 3 years)
- Rate of colostomy closure(1 years, 1.5 years, 2 years)
- Rate of severe CRP complications(3 years)
- Rate of colostomy complications(baseline, 6 months, 1 year, 2 years, 3 years)
研究者
Lei Wang
Professor
Sixth Affiliated Hospital, Sun Yat-sen University