Prospective and Randomized Trial Comparing Doppler-Guided Transanal Hemorrhoid Artery Ligation With Recto-anal Repair (HAL-RAR) Versus Excisional Hemorrhoidectomy for the Treatment of Grade III-IV Hemorrhoids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Immediate postoperative pain
研究概览
简要总结
HYPOTHESIS
- HAL- RAR causes a lower immediate postoperative pain compared with excision hemorrhoidectomy.
- HAL - RAR achieves similar immediate and long term results compared to the excision hemorrhoidectomy in the control of hemorrhoidal symptoms.
- The complication rate of HAL- RAR is low and similar to excision hemorrhoidectomy.
OBJECTIVES
- Compare postoperative pain of both techniques.
- Assess the short and long-term control of hemorrhoidal symptoms by HAL- RAR technique, and compare the results with those of the excision hemorrhoidectomy.
- Evaluate and compare the rate of complications of both techniques.
- Assess the quality of life of patients before and after treatment.
详细描述
The classic surgical treatment of hemorrhoidal disease is the excisional hemorrhoidectomy, that consist in the surgical removal of one or more hemorrhoidal cushion, it is considered a safe, radical and definitive treatment; however, it is not exempt of complications and the postoperative pain is considerable. During the last two decades the concept of treatment has evolved to control hemorrhoidal symptoms with less invasive techniques, such as hemorrhoidal bands, arterial ligation Doppler guided hemorrhoidal and more recently, the association of anorectal repair or mucopexia for treating hemorrhoidal mucosal prolapse .
MATERIAL AND METHODS
The trial was subjected to evaluation and accepted by the Ethics Committee of the Fundació Unió Catalana d'Hospitals (Catalonian Union of Hospitals Foundation).
All patients with grade III and IV hemorrhoids that are eligible for surgical treatment with both methods who agree to participate in the study, will be included in the prospective randomized trial. All patients will be required to sign the specific informed consent.
Patients who are suitable for treatment with both techniques will be randomly assigned to the surgical technique.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic grade III or IV hemorrhoids (bleeding, pain, itching, soiling or prolapse) that are eligible for surgical treatment with both methods.
排除标准
- •Associated recto-anal pathology such as acute thrombosed hemorrhoid, anal fissure, perianal fistula, perianal abscess, rectal prolapse, fecal incontinence or anal stenosis.
- •Prior anorectal surgery .
- •Systemic pathology that could alter the outcome of the surgery as coagulopathies, chronic pain with continued consumption of analgesics.
- •Age younger than 18 or older than 80 years, socio-pathology or inability to understand the study objectives
结局指标
主要结局
Immediate postoperative pain
时间窗: up to first 15 postoperative days
All patients will complete a diary testing global postoperative pain every day, measured on a numerical scale from 0 to 10 during the first 15 days.
次要结局
- Long-term control of hemorrhoidal symptoms(1, 6, 12 and 24 months after surgery)