Randomized Phase II Trial of Rectal Artery Embolization Versus Operative Hemorrhoidectomy for Treatment of Bleeding Grade 2 and 3 Internal Hemorrhoids
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Quality of Life Following Treatment
研究概览
简要总结
This Phase II study will compare rectal artery embolization with operative hemorrhoidectomy in adults with symptomatic bleeding grade 2 and 3 internal hemorrhoids. Participants will be randomly assigned to receive one of the two treatments. The study will evaluate how each treatment affects quality of life, symptom improvement, bleeding control, recovery time, and treatment-related side effects.
The main question this study is trying to answer is whether rectal artery embolization can provide better short-term quality of life compared with surgical hemorrhoidectomy one month after treatment. The study will also examine whether rectal artery embolization allows patients to return to work and normal activities sooner, reduces hemorrhoid-related bleeding, and has a different rate of treatment-related complications compared with surgery.
A total of approximately 102 adult participants will be enrolled at a single academic medical center. The results of this study may help determine whether rectal artery embolization is an effective and less invasive alternative to surgical hemorrhoidectomy for the treatment of bleeding grade 2 and 3 internal hemorrhoids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Male or female, aged >18 years
- •Goligher grade 2 or 3 internal hemorrhoids not amenable to rubber band ligation in the clinic setting
- •French bleeding score > 5
- •Rectal bleeding greater than 3 months
- •Colonoscopy within three years, negative for colorectal malignancy
- •INR < 1.5
- •Platelet count > 150,000/dL
- •For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 months after intervention
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
排除标准
- •Current use of anticoagulants and/or DAPT
- •Presence of vascular disease or previous vascular intervention preventing endovascular access to the rectal arteries
- •Prior surgical or endovascular treatment of hemorrhoids
- •Prior endoscopic hemorrhoid artery ligation
- •Pregnancy or lactation
- •Known severe allergic reactions to iodinated contrast not mitigated by standard prophylaxis
- •Bleeding attributable to other anorectal pathology such as anal fissures, anorectal abscess, or fistula
- •Inflammatory bowel disease
- •Inflammatory vasculitis or connective tissue disease
- •Current participation in another clinical trial which may interfere with participation in this study
- •Treatment with bevacizumab within 2 months
- •Contraindication to surgical management of internal hemorrhoids
- •Primary or secondary malignancy involving the abdomen or pelvis which is likely to impact treatment
- •Prior pelvic radiation therapy
- •Prior diagnosis of portal hypertension
- •Major comorbidities expected to impact outcomes or increase patient risk, in the judgement of the enrolling physician
研究组 & 干预措施
Rectal Artery Embolization
Participants will undergo rectal artery embolization for the treatment of symptomatic bleeding Goligher grade 2 and 3 internal hemorrhoids.
干预措施: Rectal Artery Embolization (Procedure)
Operative Hemorrhoidectomy
Participants will undergo operative hemorrhoidectomy for the treatment of symptomatic bleeding Goligher grade 2 and 3 internal hemorrhoids.
干预措施: Operative Hemorrhoidectomy (Procedure)
结局指标
主要结局
Quality of Life Following Treatment
时间窗: Baseline and 1 month after treatment
Comparison of quality-of-life, as measured by the Short Health Scale for Hemorrhoid Disease, 1 month following superior rectal artery embolization and open surgical hemorrhoidectomy. Scores range from 4 to 28, with lower scores indicating better quality of life and higher scores indicating worse quality of life.
次要结局
- Time to Return to Work(From treatment through return to work or normal activities, up to 6 months after treatment)
- Time to Return to Pre-Intervention Activities(From treatment until return to pre-intervention activities, up to 6 months after treatment)
- Achievement of French Bleeding Score <2(6 months after treatment)
- Treatment-Related Adverse Events(From treatment through 6 months after treatment)