Topical Endorectal Vietamin E Ovules for the Treatment of Grade 2 and 3 Hemorrhoids
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 主要终点
- % of patients with Bleeding
研究概览
简要总结
Patients with hemorrohoids grade II and III were included. Patients were randomized into 2 groups:
- Experimental group: Patients will receive a treatment with vitamin E ovules, which must be placed inside the annus
- Control group: Patients will receive a treatment with corticoid ointment, with endoanal application
Bleeding, pain and stinging will be evaluated 14 days after beginning the treatment.
详细描述
Patients with hemorrohoids grade II and III were included.
Patients were randomized into 2 groups:
- Experimental group: Patients will receive a treatment with vitamin E ovules, which must be placed inside the annus. 1 ovule must be inserted daily during 14 days.
- Control group: Patients will receive a treatment with prednisolone ointment, with endoanal application 3 times per day during 14 days.
Bleeding, pain and stinging will be evaluated 14 days after beginning the treatment. Quantification of pain will be performed following a visual analogic scale ranging from 0 (absence of symptoms) to 100 (unbearable symptoms).
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
- Single (Outcomes Assessor)
盲法说明
Symptoms will be assessed by a nurse blinded to the prescribed treatment
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
- •Grade II and III hemorrhoids
排除标准
- •Grade I or IV hemorrhoids
- •Patients with previous anal surgeries
- •Patients having received previous pharmacological treatments for hemorrhoids
研究组 & 干预措施
Vitamin E ovules
Endoanal Vitamin E ovules will be prescriped during 14 days
干预措施: Vitamin E ovules (Drug)
Prednisolone ointment
Endoanal Prednisolone ointment will be prescriped during 14 days
干预措施: Prednisolone ointment (Drug)
结局指标
主要结局
% of patients with Bleeding
时间窗: 14 days after beginning the treatment
The patient refers rectal bleeding during defecation (patients´self-report) or active bleeding is observed at rectal examination. The variable will be measured as present (1) or absent(0)
次要结局
- Anal pain assessed by Visual Analogic Scale(14 days after beginning the treatment)
- % of patients with Stinging(14 days after beginning the treatment)
研究者
Jaime Ruiz-Tovar, MD, PhD
Department of Surgery
Hospital General Universitario Elche