Mucopexy Versus Laser Hemorrhoidoplasty for the Treatment of Hemorrhoidal Disease, a Prospective Randomized Controlled Trial
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
- 是
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
Ris Frederic
Clinical Professor Frédéric Ris
University Hospital, Geneva
