Patient Comfort After Stapled Hemorrhoidopexy Long Term Results of a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 130
- 主要终点
- Postoperative Pain
研究概览
简要总结
The purpose of this study was to determine the influence on Patient comfort after Stapled Hemorrhoidopexy versus Milligan Morgan (two surgical procedures)in third degree circular hemorrhoids.
详细描述
There are well known advantages in the short-outcome, however, there are still some uncertainties about the long-term results and recurrence rates, and only a few data of randomized trials are available.
In most studies the patient population was heterogeneous with a varied degree of treated hemorrhoids, and different surgical procedures were performed. Therefore we initiated this prospective randomized controlled study of a homogeneous patient population with only circular third-degree hemorrhoids and clearly defined operative procedures. All patients with symptomatic, reducible circular third-degree hemorrhoidal disease were randomly assigned to undergo either the Milligan-Morgan technique or the stapling procedure. Patients were excluded from the study if they had single third-degree hemorrhoids, acute incarcerated hemorrhoids, intercurrent acute anal fissure and/or acute anal fistula, or prior hemorrhoidectomy. The main end point parameter of this study was to compare both groups with respect to patient comfort and postoperative pain. Secondary end points included the long-term recurrence rate of hemorrhoidal disease after a minimum of 4 years.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •third degree circular hemorrhoids
- •symptomatic
- •reducible
排除标准
- •single third-degree hemorrhoids
- •acute incarcerated hemorrhoids
- •intercurrent acute anal fissure
- •acute anal fistula
- •prior hemorrhoidectomy.
结局指标
主要结局
Postoperative Pain
时间窗: within the first 30 days after surgery
次要结局
- long-term recurrence rate(up to 5 years after surgery)
研究者
Dr. med. Asad Kutup
Senior Surgeon
Universitätsklinikum Hamburg-Eppendorf
