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临床试验/NCT04881344
NCT04881344Unknown不适用

Mucopexy Versus Laser Hemorrhoidoplasty for the Treatment of Hemorrhoidal Disease, a Prospective Randomized Controlled Trial

Ris Frederic0 个研究点目标入组 42 人开始时间: 2021年6月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
42
主要终点
The Symptom Score

研究概览

简要总结

Hemorrhoidal disease is a frequent anorectal disorder and the main reason for a visit to a coloproctologist. Hemorrhoids are present in healthy individuals. However, they can become pathologic, manifesting with pain, prolapse, itching, bleeding or soiling. Initially, they can be managed conservatively. When this failed to cure the symptoms, surgical therapy is indicated. For grade II (hemorrhoids prolapsing during straining but reducing spontaneously) or grade III (hemorrhoids prolapsing during straining but requiring manual reduction), laser hemorrhoidoplasty or mucopexy are safe and efficient procedures to treat hemorrhoids. However, the optimal treatment is still under debate. Recently, a randomized controlled trial reported lower recurrence and faster return to work associated with laser therapy. We aimed to compare both therapies, to assess the benefits of laser therapy for the treatment of hemorrhoidal disease symptoms, using a validated score.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Informed Consent as documented by signature
  • Hemorrhoidal disease grade II to III unresponsive to medical therapy

排除标准

  • Inability to follow the procedures of the study,
  • Enrollment of the investigator, his/her family members, employees and other dependent persons,
  • Anesthesiology contraindications to surgery,
  • Emergency situation,
  • Hemorrhoids associated with pregnancy,
  • Oher surgical intervention performed at the same time of the hemorrhoids treatment,
  • Concomitant anorectal disorders (fissure, fistula), thrombosed hemorrhoid,
  • Previous pelvic radiotherapy, previous proctologic intervention during the last three months.

结局指标

主要结局

The Symptom Score

时间窗: 6 postoperative months

The primary outcome will be the "Symptom Score" at six postoperative months. This score ranges from 0 to 15 points, based on each of the five cardinal symptoms of hemorrhoidal disease (pain, itching, bleeding, discharge and prolapse) attributed from 0 to 3 points according to the frequency of their manifestation (0 point: never, 1 point: \> 1x/month, \<1x/week, 2 points: 1-6x/week, 3 points: 1x/day).

次要结局

未报告次要终点

研究者

发起方
Ris Frederic
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ris Frederic

Clinical Professor Frédéric Ris

University Hospital, Geneva

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