Safety and Short Term Effectiveness of EEA Stapler vs PPH Stapler in the Treatment of III Degree Haemorrhoids. Prospective Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- quantity of anorectal mucosa resected using two different circular staplers
研究概览
简要总结
Stapled hemorrhoidopexy has gained wide acceptability among colorectal surgeons because of less postoperative pain compared with excisional surgery, however a still relevant percentage of postoperative bleedings and long-term hemorrhoid recurrence are reported. A new stapler device has been designed to overcome these drawbacks by modifying the stapled sutures and by increasing the space for mucosal resection in the case of the stapler.
This randomized controlled study was aimed to demonstrate whether the new EEA stapler Covidien was able to resect more quantity of prolapsed mucosa than the traditional PPH 01/03 Ethicol Endosurgery by measuring the surface of the resected specimen and to demonstrate if the modified stapled sutures can ensure better intraoperative hemostasis by measuring the number of overstitches required to get perfect hemostasis during the operation.
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
- None
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
- •III degree Hemorrhoids
- •written informed consent
- •mental ability to understand the procedure
排除标准
- •Previous treatments for hemorrhoids or other proctological diseases
- •Fecal Incontinence
- •Chronic inflammatory bowel disease
- •Anal sphincter lesions
- •coagulative defects
- •obstructed defecation
结局指标
主要结局
quantity of anorectal mucosa resected using two different circular staplers
时间窗: 1 hour following the end of the operation
The surface (in cm2)of anorectal mucosa resected during stapled hemorrhoidopexy for III degree hemorrhoids, using two different circular staplers will be compared
次要结局
- Number of hemostatic stitches required to get perfect hemostasis using 2 different staplers(1 hour after each operation)
研究者
Donato F Altomare
Associate professor
Societa Italiana di Chirurgia ColoRettale