Radiofrequency Haemorrhoidal Thermoablation Versus Doppler-guided Haemorrhoidal Artery Ligation With Mucopexy in the Treatment of Haemorrhoidal Disease: a Multicenter Randomized Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 20
- 主要终点
- Failure rate at one year post-operatively
研究概览
简要总结
Surgical treatment of grade II/III internal haemorrhoidal disease is indicated in the case of medical and/or instrumental treatment failure. Minimal invasive alternatives to haemorrhoidectomy have been introduced in the last decades to treat grade II/III haemorrhoids. Doppler-Guided haemorrhoidal artery ligation (DGHAL) represents a good therapeutic option in this condition with good short and mid-term outcomes but postoperative recurrence rates up to 35% at 5 years.
Recently, a technique of radiofrequency ablation (RFA) has been introduced with promising outcomes. A recent systematic review reported a significant improvement of preoperative symptoms and a recurrence rate < 5%.
To date, there is no study comparing DGHAL to RFA in the treatment of grade II/III haemorrhoids.
The aim of this study is to demonstrate the non-inferiority in terms of failure rate of haemorrhoidal radiofrequency ablation compared to Doppler-guided haemorrhoidal artery ligation, associated with mucopexy, in the treatment of grade II and III haemorrhoidal disease
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
- •Major patient,
- •With symptomatic Grade II or III haemorrhoidal disease,
- •Requiring surgical management,
- •Patient able to understand the protocol and having given written informed consent to participate in the study,
- •Patient affiliated to the social security system or entitled to it.
排除标准
- •Hemostasis disorders
- •Active external haemorrhoidal disease (thrombosis)
- •History of surgical procedure for treatment of haemorrhoids (instrumental treatment is not a contra-indication)
- •Associated proctological pathology (anal fissure, chronic suppuration, external rectal prolapse)
- •History of colorectal cancer
- •History of inflammatory bowel disease
- •History of rectal resection
- •Patient participating in another interventional clinical research protocol involving a drug or clinical investigation of a medical device
- •Patient who is pregnant, breastfeeding or able to procreate without effective contraception* at the time of inclusion
- •Patient under guardianship, curators or deprived of liberty.
- •Patient under court protection.
- •oral contraceptive (pill), monthly vaginal ring, weekly transdermal patch, subcutaneous implant, intrauterine devices (IUD), or sterilisation.
研究组 & 干预措施
Radiofrequency Ablation
Patients will be treated by radiofrequency ablation.
干预措施: Radiofrequency ablation (Procedure)
Doppler-Guided Haemorrhoidal Artery Ligation
Patients will be treated by DGHAL procedure.
干预措施: Doppler-Guided Haemorrhoidal Artery Ligation (Procedure)
结局指标
主要结局
Failure rate at one year post-operatively
时间窗: one year post-operatively
The evaluation of failure rate will be based on the calculation of the HDSS score grouping the different symptoms (pain, discomfort, bleeding, soiling and prolapse). Failure rate will be defined by a score greater than or equal to the preoperative score or by a reoperation (surgical or instrumental) for relapse of the symptoms.
次要结局
未报告次要终点