Application of Vitamin E Acetate Ointment vs Nitroglycerin Ointment for the Treatment of Chronic Anal Fissure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Pain associated to anal fissure: Visual Analogic Scale
研究概览
简要总结
Patients were randomized into 2 groups:
- Vitamin E: Vitamin E ointment will be applied during 8 weeks
- Nitroglycerin: Nitroglycerin ointment will be applied during 8 weeks
Healing rate of chronic anal fissure in patients receiving Nitroglycerin ointment and subjects patients receiving Vitamin E ointment were evaluated .
详细描述
Patients were randomly assigned to experimental and control groups: those patients receiving vitamin E ointment (Experimental Group - EG) and those receiving glyceryl trinitrate ointment (Control Group - CG).
Treatments:
Glyceryl trinitrate ointment (GTO): Commercially available aluminium tubes containing 0.4 glyceryl trinitrate ointment (Rectogesic, proStrakan Group, Galashiels, UK) were purchased from pharmacies. The dosage for all the patients was 375 mg of ointment (containing 1.5 mg of glyceryl trinitrate), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period.
Vitamin E acetate ointment (VEA): Commercially available plastic tubes containing VitaminE acetate ointment (Filme Olio, Hulka SRL, Italy) were purchased from pharmacies. The dosage for all the patients was 1ml, applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period.
Healing rate of chronic anal fissure was investigated.
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
A nurse blinded to the treatment applied will evaluate the healing of chronic anal fissure and quantify pain
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
- •Patients with diagnosis of chronic anal fissure
排除标准
- •patients with associated anal pathologies
- •intestinal inflammation disorders
- •immunosuppression
- •fissures secondary to underlying diseases (eg, AIDS, tuberculosis, or sexually transmitted diseases)
- •patients with a history of headaches, heart disease, or intolerance to nitrates
- •pregnant or lactating women
- •patients with closed angle glaucoma
研究组 & 干预措施
Vitamin E acetate
Commercially available plastic tubes containing vitamin E acetate ointment (Filme Olio, Hulka SRL, Italy) were purchased from pharmacies. The dosage for all the patients was 1ml of ointment (containing 1100% vitamin E), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period.
干预措施: Vitamin E Acetate ointment (Drug)
Glyceryl trinitrate ointment
Commercially available aluminium tubes containing 0.4 glyceryl trinitrate ointment (Rectogesic, proStrakan Group, Galashiels, UK) were purchased from pharmacies. The dosage for all the patients was 375 mg of ointment (containing 1.5 mg of glyceryl trinitrate), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period.
干预措施: Glyceryl trinitrate ointment (Drug)
结局指标
主要结局
Pain associated to anal fissure: Visual Analogic Scale
时间窗: 8 weeks
Pain will be evaluated after finishing the treatment, by a Visual Analogic Scale, ranging from 0 (absence of pain) to 100mm (unbearable pain)
次要结局
- Number of participants achieving the healing of the fissure(8 weeks)
研究者
Jaime Ruiz-Tovar, MD, PhD
Department of Surgery
Hospital General Universitario Elche