Reduction of Postoperative Pain and Improvement of Patients´Comfort After Milligan-Morgan Haemorrhoidectomy With Application of Vitamin E Ointment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Postoperative pain
研究概览
简要总结
A prospective ranfomized clinical study of patients undergoing Milligan Morgan´s haemorrhoidectomy at Hospital Universitario Rey Juan Carlos (Móstoles-Spain) will be performed. The patients will be randomized into 2 groups:
- Experimental group (EG): Patients undergoing Milligan Morgan´s procedure and application of Vitamin E ointment on the surgical bed.
- Control group (CG): Patients undergoing Milligan Morgan´s procedure and application of Vaseline on the surgical bed.
Postoperative pain determined by VAS at the 1st, 3rd and 7th postoperative days, and need for morphine rescue will be investigated.
详细描述
A prospective ranfomized clinical study of patients undergoing Milligan Morgan´s haemorrhoidectomy at Hospital Universitario Rey Juan Carlos (Móstoles-Spain) will be performed. The patients will be randomized into 2 groups:
- Experimental group (EG): Patients undergoing Milligan Morgan´s procedure and application of Vitamin E ointment on the surgical bed.
- Control group (CG): Patients undergoing Milligan Morgan´s procedure and application of Vaseline on the surgical bed.
Postoperative pain determined by VAS at the 1st, 3rd and 7th postoperative days, and need for morphine rescue will be investigated by a blined epidemiology nurse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing Milligan Morgan´s haemorrhoidectomy at Hospital Universitario Rey Juan Carlos (Móstoles-Spain).
- •Haemorrhoids grade III and IV
- •The patients sign an Informed Consent Form agreeing their participation in the study.
排除标准
- •Patients undergoing other surgical techniques for haemorrhoidectomy, different tan Milligan Morgan
- •Haemorrhoids grade I and II
- •Patients with medical or surgical pathologies that do not allow the participation in the study
- •Disability to understand and accept the entry in the study
研究组 & 干预措施
Vitamin E ointment
Vitamin E ointment application. Every 12 hours during 7 days.
干预措施: Vitamin E ointment application (Drug)
Vaseline ointment
Vaseline ointment application. Every 12 hours during 7 days.
干预措施: Vaseline ointment application (Drug)
结局指标
主要结局
Postoperative pain
时间窗: From the first to the 7th postoperative days
Postoperative pain will be quantified with a VAS scale at the 1st, 3rd and 7th postoperative days
次要结局
- Need for morphine rescue(24 hours after surgery)
研究者
Jaime Ruiz-Tovar, MD, PhD
Professor of Surgery
Hospital General Universitario Elche