Open Hemorrohoidectomy Versus Transanal Hemorrhoidal Desarterialization in Hemorrhoids Grade III: The Effect on Symptons: An Open-label Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- hemorrhoidal disease symptom score
研究概览
简要总结
The goal of this clinical trial is to learn if open hemorroidectomy diminishes symptoms compared to transanal hemorrhoidal desarterialization (THD) in patients presenting with hemorrhoids grade III. The main question it aims to answer is:
- Do patients undergoing open hemorroidectomy present with lesser symptoms 1 year after surgery, compared to those undergoing a THD?
Researchers will compare open hemorroidectomy to THD in terms of symptom response one year after the procedure.
Participants will:
- Undergo surgical treatment of hemorroids performed by one of the two techniques: open hemorroidectomy versus THD.
- Fill in symptom forms before and one year after the surgical procedure.
- Attend control visits one week, one month, three months and one year after the surgical procedure.
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
- 否
入选标准
- •Age older than
- •Hemorroids grade III.
- •Surgical indication for hemorroid treatment.
- •Signed informed consent.
排除标准
- •Acute hemorroidal disease.
- •Previous hemorroidal surgery.
- •Concomitant anal fissure.
- •Concomitant perianal fistulae.
- •Concomitant rectal prolapse.
- •Inflamatory bowel disease.
- •Anal or colorrectal cancer.
研究组 & 干预措施
Transanal Hemorrhoidal Dearterialization
干预措施: Transanal Hemorrhoidal Dearterialization (Procedure)
Hemorrhoidectomy
干预措施: Open Hemorrhoidectomy (Procedure)
结局指标
主要结局
hemorrhoidal disease symptom score
时间窗: one year
A score that defines the frecuency of pain, pruritus, bleeding, soiling and prolapse. Score 0 to 20. Higher scores mean a worse outcome
short health scale in hemorrhoidal disease
时间窗: one year
a subjective scale which defines symptom intensity, the patient's worrying and the role in impairment of daily activity. Score 4 to 28. Higher scores mean a worse outcome
Hemorrhoidal Disease Symptom Score
时间窗: one year
A score that defines the frecuency of pain, pruritus, bleeding, soiling and prolapse. Score 0 to 20. Higher scores mean a worse outcome
Short Health Scale in Hemorrhoidal Disease
时间窗: one year
a subjective scale which defines symptom intensity, the patient's worrying and the role in impairment of daily activity. Score 4 to 28. Higher scores mean a worse outcome
次要结局
- fecal incontinence(baseline and 1 week, 3 months and 1 year after surgical procedure)
- postoperative pain(1 week after surgical procedure)
- Postoperative Pain(1 week after surgical procedure)
- Fecal Incontinence(one year after surgical procedure)
研究者
Ignacio Fernandez Hurtado
Specialist in General Surgery. Specialist in Digestive Surgery
Hospital Son Llatzer