Topical Versus Oral Metronidazole for Pain Relief After Surgery for Benign Anorectal Conditions; a Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Postoperative pain score
研究概览
简要总结
While some investigators found oral metronidazole to be effective in reducing pain after hemorrhoidectomy, other researchers did not find a significant analgesic effect of systemic metronidazole. On the other hand, topical application of metronidazole had more consistent favorable results as Ala et al documented a remarkable analgesic effect of topical metronidazole 10% after excisional hemorrhoidectomy which was in line with Nicholson and Armestrong who also concluded similar results.
No previous study compared the analgesic effect of topical and oral metronidazole after anorectal surgery. Therefore, the present trial was conducted to compare the impact of oral versus systemic metronidazole on pain and recovery after surgery for benign anorectal conditions.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients of either sex aged below 70 years
- •Underwent surgery for hemorrhoids, anal fissure, or simple anal fistula.
排除标准
- •Grade I-II hemorrhoids.
- •acute anal fissure.
- •complex anal fistula
- •perianal abscess
- •perianal Crohn's disease
- •malignancy.
研究组 & 干预措施
Topical metronidazole
Topical application of metronidazole cream on the anal verge after surgery
干预措施: Topical metronidazole (Drug)
Oral metronidazole
oral metronidazole 500 mg tablets after surgery
干预措施: oral metronidazole (Drug)
结局指标
主要结局
Postoperative pain score
时间窗: at seven days after surgery
Pain was assessed using visual analogue scale form 0 to 10, higher score indicates worse pain
次要结局
未报告次要终点
研究者
Sameh Emile
Associate professor of surgery
Mansoura University