跳至主要内容
临床试验/NCT01533363
NCT01533363已完成3 期

Patient Comfort After Stapled Hemorrhoidopexy Long Term Results of a Randomized Controlled Trial

Universitätsklinikum Hamburg-Eppendorf0 个研究点目标入组 130 人开始时间: 2000年7月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. med. Asad Kutup

Senior Surgeon

Universitätsklinikum Hamburg-Eppendorf

相似试验

Study About Patient Comfort and Long-term Outcome... | 临床试验