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临床试验/NCT04058223
NCT04058223已完成不适用

Taipei Medical University Shuang-Ho Hospital

Taipei Medical University Shuang Ho Hospital1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2018年9月5日最近更新:
适应症

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

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

发起方
Taipei Medical University Shuang Ho Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tungcheng Chang

Chief of colorectal surgery

Taipei Medical University Shuang Ho Hospital

研究点 (1)

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