Cost-effectiveness of New Surgical Treatments for Haemorrhoidal Disease - Randomized Controlled Trial Comparing Transanal Doppler-guided Arterial Ligation With Mucopexy and Stapled Haemorrhoidopexy (Longo's Technique)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 407
- 试验地点
- 24
- 主要终点
- Morbidity at 60 days postoperatively of the 2 techniques
研究概览
简要总结
This multicentre RCT aims to compare two surgical treatments of haemorrhoidal disease: doppler-guided arterial ligation with mucopexy (DGALM) and stapled haemorrhoidopexy according to Longo (SH). The hypothesis of the trial is that the DGALM is at a lesser risk and is more cost-effective than SH. With a large number of patients managed in more than 20 centres, we aim to demonstrate that DGALM has a lower morbidity than SH when treating haemorrhoidal disease. At a lower postoperative risk and a lower risk of sequelae, the DGALM would demonstrate to be cost-effective for health care system and attractive for patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient (male or female) 18 - 75 y.o
- •Suffering from symptomatic grade II or III haemorrhoidal disease (bleeding and/or prolapse)
- •requiring surgery
排除标准
- •Acute complication of haemorrhoidal disease
- •History of anal surgery for haemorrhoids
- •Congenital or acquirred anal stenosis
- •Anal fissure or perianal abcess
- •Inflammatory bowel disease
- •Colon or rectal cancerv History of rectal or sigmoid resection
- •Rectal prolapse
- •Portal vein hypertension
- •Haemophylia
- •Pregnancy
研究组 & 干预措施
SH
stapled haemorrhoidopexy according to Longo
干预措施: stapled haemorrhoidopexy according to Longo (Device)
DGALM
doppler-guided arterial ligation with mucopexy
干预措施: doppler-guided arterial ligation with mucopexy (Device)
结局指标
主要结局
Morbidity at 60 days postoperatively of the 2 techniques
时间窗: 60-90 days
Morbidity at 60 days postoperatively of the 2 techniques, the morbidity being defined as " the sum of adverse events that occurred during or after the procedure for a period of 2 months".Primary outcome measure is "the percentage of patients with complication, whatever the number of complications per patient and the grade of complication according to the Clavien-Dindo classification".
次要结局
- Cost-effectiveness of the 2 procedures(12 months)
- Success rate at 1 year of each procedure regarding the control of haemorrhoids symptoms(1 year)
- Rate of anatomical or functional sequelae(1 year)