Taipei Medical University Shuang-Ho Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Complication
研究概览
简要总结
The hemorrhoidal disease affects approximately 4.4%-36% of the general population, and it has been estimated that >50% of the population aged >50 years experiences hemorrhoidal problems . Traditional hemorrhoidectomy, including Milligan-Morgan, Ferguson, and Whitehead procedures , are known to cause significant postoperative pain and discomfort and result in a poor quality of life after operation. Since the first introduction of the novel procedure hemorrhoidopexy by Longo in 1998, it has been considered as a safe procedure causing less postoperative pain and resulting in earlier recovery; furthermore, the patients are able to resume their normal daily life and work. The PPH stapler (Ethicon Endo-Surgery, Inc. Cincinnati, OH, USA) was also first introduced in 1998 as a device to perform this procedure. Subsequently, a new device, the DST stapler (Covidien, Mansfield, MA, USA), was introduced in 2008 with some structural differences, including a detachable anvil, three anchor points over different levels, a larger case, and different agraffe sizes.
However, the majority of current studies have been focusing on the use of PPH stapler for hemorrhoidopexy, and comparison with the DST stapler has been rarely discussed. One randomized controlled trial that compared between the PPH stapler and the DST stapler reported that the DST stapler demonstrated a better hemostatic ability and allowed the resection of a larger area of mucosal prolapse; however, that trial focused only on bleeding among the postoperative complications. Currently, only a limited number of studies have compared these two devices in terms of pain, complications, and anorectal stricture incidence rate. The present investigation is a matched cohort-control study aimed to compare the postoperative short-term outcomes among patients with grade III and IV hemorrhoids who were treated with either the PPH or the DST stapler. The specimen surface area and the relationships with complications were also analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Grade III and grade IV hemorrhoid
排除标准
- •Anal fistula, rectal polyo\p
结局指标
主要结局
Complication
时间窗: 3 months
Post-OP bleeding, urinary retention, anaorectal stricture, PPH syndrome
次要结局
未报告次要终点
研究者
Tungcheng Chang
Chief of colorectal surgery
Taipei Medical University Shuang Ho Hospital
