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临床试验/NCT06079892
NCT06079892招募中不适用

Evaluation of Radiofrequency Efficiency in the Treatment of Hemorrhoid Pathology

Fondation Hôpital Saint-Joseph1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Evaluation of radiofrequency treatment efficiency

研究概览

简要总结

Triapedicular haemorroidectomy is currently the gold standard in haemorrhoidal pathology. Minimally invasive surgical techniques now play an important role in the haemorrhoidal management algorithm, particularly for less advanced stages of the disease. Among these techniques, radiofrequency is one of the most recent and is gradually gaining ground. It involves applying a radiofrequency current to the internal haemorrhoidal tissue in order to induce its involution.

The literature has shown that this technique leads to symptomatic improvement in over 60% of cases and a high satisfaction rate, even though some patients still seem to have haemorrhoidal symptoms postoperatively.

The aim of this study is to evaluate the efficacy of this technique in patients with haemorrhoidal pathology operated on at our centre, using "hard" criteria which are thought to be more rigorous ("cure" rather than "improvement").

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Presence of haemorrhoidal pathology
  • Patient operated on between March 2017 and March 2023, using the radiofrequency technique
  • French-speaking patient

排除标准

  • ano-perineal involvement in Crohn's disease
  • perianal fistula
  • non-quiescent IBD
  • radiation-induced rectitis
  • psychiatric pathology.
  • under guardianship or curatorship
  • deprived of liberty
  • under court protection
  • Patient objecting to the use of his/her data for this research

结局指标

主要结局

Evaluation of radiofrequency treatment efficiency

时间窗: 3 months post procedure

Assessement of the procedure efficiency on prolapsus (using Goligher Score) and bleeding (using Haemorrhoidal bleeding score). Procedure is considered efficient when Goligher Score =1 AND HBS = 0

次要结局

  • Identification of predictive factor for success(3 months post procedure)
  • Measurement of patient satisfaction after surgery(3 months post procedure)
  • Incidence rate of procedure complication(3 months post procedure)
  • description of procedure complication(3 months post procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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