Topical Application of GTN 0.4% in the Treatment of Anismus Following Stapled Haemorrhoidopexy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Postoperative pain related to upper anal canal pressure increasing (yes or no)
研究概览
简要总结
This study wants demonstrate that the use of 0.4% nitroglycerin ointment can reduce the postoperative pain related to anorectal spasm (anismus) while performing a stapled haemorrhoidopexy.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic II-III grade haemorrhoids and rectal mucosal prolapse
- •Adults aged ≤ 75, male or female
排除标准
- •Concomitant ano-rectal disease (fissure, fistula, abscess, inflammatory bowel disease, rectal cancer)
研究组 & 干预措施
GTN
In this arm the investigators administer local application of 0.4% nitroglycerin ointment and ketorolac tromethamine 10 mg
干预措施: 0.4% nitroglycerin ointment (Drug)
Control
In this arm the investigators administer local application of lidocaine cloridrato 2.5% and ketorolac tromethamine 10 mg.
干预措施: lidocaine cloridrato 2.5% ointment (Drug)
结局指标
主要结局
Postoperative pain related to upper anal canal pressure increasing (yes or no)
时间窗: from the intervention to 1 month
To evaluate if the pain post stapled haemorrhoidopexy is related to an increased anal resting pressure or not. The presence of anorectal spasm was assessed by clinical examination and anorectal manometry
Postoperative pain remission
时间窗: from 1 to 90 days after intervention
To assess postoperative pain remission
Postoperative anal resting pressure at pain remission
时间窗: from 1 to 90 days after intervention
We evaluate with anorectal manometry the anal resting pressure at the time of pain remission
次要结局
- Duration of therapy(from 1 to 90 days after intervention)
- Use of additional analgesic(from 1 to 90 days to intervention)
- Postoperative pain intensity(from 1 to 90 days after intervention)
- Patients satisfaction(45 days after intervention)