New Option for the Treatment of Radiation-induced Proctitis Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of Petechiae in the most affected areas of the rectal mucosa.
研究概览
简要总结
A prospective single-center observational study to evaluate the effectiveness of a local treatment with a mixture of hyaluronic acid, chondroitin sulfate and poloxamer 407 in patients with radiation-induced proctitis.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •proven symptomatic acute or chronic radiation-induced proctitis;
- •current or prior radiation therapy in the pelvic area;
- •patients with complications connected to the radiation therapy.
排除标准
- •lack of informed consent;
- •non-adherence to study protocol;
- •pregnancy.
结局指标
主要结局
Number of Petechiae in the most affected areas of the rectal mucosa.
时间窗: 1 month
Assessment of the effects of the mixture on the number of petechiae in the rectum. Within the first flexible rectoscopy (Day 1) the most affected areas of the rectal mucosa (on the anterior and posterior wall) will be determined. A 27 mm CAPTIVATOR hexagonal polypectomy snare (Boston Scientific) will be introduced through the endoscope, and will be fully opened. The fully open polypectomy snare (9,2 cm2) will be applied over the most affected areas on the anterior and posterior rectal wall, and the number of the petechiae within these areas will be documented. The flexible rectoscopy will be repeated on day 8 after patients have already received enemas with the examined substance twice daily for one week, and the number of the petechiae will be documented as above mentioned. After a period of 23 days with no treatment, a follow-up flexible rectoscopy will be performed on day 31, and the petechiae of the rectal mucosa will be once more assessed.
次要结局
- Assessment of patients' quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Proctitis Module with 20 Questions (EORTC QLQ-PRT20)(6 months)
研究者
ILIYAN ILIEV
Principal Investigator, General Surgeon
Barmherzige Brüder Vienna