跳至主要内容
临床试验/NCT04896268
NCT04896268招募中不适用

Prospective, Multicentric, Randomized, Open-label Study Comparing the Efficacy, in Terms of Quality of Life, and Safety of RAdiofrequency Versus HAL- RAR DOppler in Hemorrhoidal Pathology

Elsan4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
4
主要终点
To demonstrate an increase in quality of life, at 1 month post-procedure, when haemorrhoidal disease is managed with radiofrequency versus HAL-RAR with Doppler

研究概览

简要总结

Haemorrhoids are composed of tissue rich in blood vessels and are present in all individuals inside the anus (internal haemorrhoids) or under the skin of the anus (external haemorrhoids). Haemorrhoidal disease (HD) occurs when haemorrhoids become troublesome and cause symptoms such as pain, bleeding, prolapse or oozing. In case of failure of medical treatment, instrumental procedures or extensive disease, surgical treatment can be considered. There are two classic surgical techniques. The first is the pedicle haemorrhoidectomy of the Milligan and Morgan type. The second classic surgical technique is the Longo stapled anopexy. Recently, less invasive surgical techniques such as arterial ligation (HAL, with or without Doppler) followed by recto-anal repair (RAR for "Recto Anal Repair") and sometimes associated with mucopexy, which allows the excess mucosa to be ligated and the muco-haemorrhoidal tissue to be fixed to the rectal wall, have developed. The use of radiofrequency current (Rafaelo technique) in the treatment of haemorrhoidal disease is an innovative technique of haemorrhoidal thermocoagulation. It is a mini-invasive technique, which can be performed under sedation or short general anaesthesia (GA), with little pain, allowing a rapid return to normal life and a short time off work. Although this technique is already used in other European countries: Poland, Germany, Belgium, Great Britain (UK), there is now a Polish, German, Spanish and English study in the process of publication. There have been no studies in France to evaluate this new technique and assess its good tolerance, the duration of work stoppage, the improvement in quality of life and the evaluation of its effectiveness.

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

入选标准

  • Male or Female consulting for hemorrhoidal pathology (grade II or III) after failure of medico-instrumental treatments.
  • Age ≥ 18 years and < 75 years
  • Mandatory affiliation to a health insurance system.
  • Patient having been informed of the study and having given informed consent

排除标准

  • Patients with chronic inflammatory bowel disease
  • Patients with suspected gastro-colic pathology
  • Haematological diseases
  • Anal fistulas
  • Patients unable to discontinue anti-vitamin K or oral anticoagulants
  • Associated anal fissure
  • External haemorrhoidal disease
  • Pregnant or breastfeeding women
  • Patients under legal protection

结局指标

主要结局

To demonstrate an increase in quality of life, at 1 month post-procedure, when haemorrhoidal disease is managed with radiofrequency versus HAL-RAR with Doppler

时间窗: 1-month visit

The Haemorrhoidal Disease and Anal Fissure questionnaire

次要结局

  • Safety evaluation(through study completion, an average of 6 months)
  • Pain evaluation(6-month visit)
  • feasibility of the 2 techniques under simple antiplatelet agents, anti-vitamin K or oral anticoagulant.(6-month visit)
  • Recording of specific symptoms that indicate improvement in hemorrhoidal disease(through study completion, an average of 6 months)
  • Occurrence of a relapse(through study completion, an average of 6 months)
  • Time to return to work(through study completion, an average of 6 months)

研究者

发起方
Elsan
申办方类型
Other
责任方
Sponsor

研究点 (4)

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