跳至主要内容
临床试验/NCT04731064
NCT04731064招募中不适用

Recurrence Rate of Hemorrhoidal Disease at 10 Years and More After Hemorrhoidal Artery Ligation (HAL)

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年1月6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
500
试验地点
1
主要终点
The rate of recurrence leading to a re-intervention within 10 years of the intervention.

研究概览

简要总结

The treatment of hemorrhoidal disease involves both instrumental and surgical techniques (hemorrhoidectomy and hemorrhoidopexy). In 1995, a Japanese author proposed a new treatment technique for stage II (spontaneous reintegration prolapse) or III (digital reintegration prolapse) disease, based on Doppler identification of low perirectal arteries followed by their ligation, via a specific windowed rectoscope. Later, a further modification appeared, allowing patients to be treated at more advanced stages, adding vertical mucopexy to the ligatures along the main bundles.

The pathophysiology of hemorrhoidal disease is based on a vascular theory (opening of arteriovenous shunts) and on a mechanical theory (distension of the supporting tissue). Hemorrhoidectomy responds to the first, hemorrhoidopexy to the second. The HAL (Hemorrhoidal Artery Ligation) - RAR (Recto-Anal Repair) technique seeks to treat both vascular (by ligation of the nourishing arteries) and mechanical (by mucopexy of prolapsed bundles) components. The technique first spread to Germany, Russia, Italy, Spain, Australia and England. It has been popularized in France by some authors.

详细描述

The treatment of hemorrhoidal disease involves both instrumental and surgical techniques (hemorrhoidectomy and hemorrhoidopexy). In 1995, a Japanese author proposed a new treatment technique for stage II (spontaneous reintegration prolapse) or III (digital reintegration prolapse) disease, based on Doppler identification of low perirectal arteries followed by their ligation, by a specific windowed rectoscope. Later, a further modification appeared, allowing patients to be treated at more advanced stages, adding vertical mucopexy to the ligatures along the main bundles.

Physiopathological basis of HAL Doppler The pathophysiology of hemorrhoidal disease is based on a vascular theory (opening of arteriovenous shunts) and on a mechanical theory (distension of the supporting tissue). Hemorrhoidectomy responds to the first, hemorrhoidopexy to the second. The HAL (Hemorrhoidal Arttery Ligation) - RAR (Recto-Anal Repair) technique seeks to treat both vascular components (by ligation of the nourishing arteries) and mechanical (by mucopexy of prolapsed bundles). The technique first spread to Germany, Russia, Italy, Spain, Australia and England. It was popularized in France by some authors.

Description of the operation The patient is operated on in the perineal first position, under general anesthesia or under locoregional or even local anesthesia. Most of the time, the procedure is performed on an outpatient basis, after rectal preparation with a simple enema.4,5 The equipment (there are several types) for HAL comprises a transparent disposable rectoscope provided near its end with a centimeter window through which the x-point ligatures of slowly absorbable 2/0 thread will be made. It contains a light source facilitating the exposure of the internal surface of the rectum and a Doppler transducer secured to the base of the rectoscope containing the Doppler system itself. The assembly is connected to a generator which will transmit the Doppler noises to the surgeon. A printer on the generator allows ligatures to be mapped and the depth of linked arteries to be noted.6 The rest of the equipment includes a needle holder, knot pusher, scissors and dissecting forceps to dab the surgical site if necessary.2 The material for HAL with mucopexy is identical, except for the disposable rectoscope which is much more indented at its end and on one side (and at the time of arterial ligation, covered by a metal or opalescent jacket leaving a window), so as to be able to carry out a vertical overlock in the lower rectum, above the package that the operator intends to treat. It is thus possible to make one or more mucopexies depending on the operative findings.

The procedure takes about 20 to 30 minutes. Two circumferential explorations are performed at the level of the lower rectum, approximately 25 and 40 mm above the pectinate line. Patients on anticoagulant or antiplatelet therapy can be operated using this technique, since there is no wound. The patient leaves the same day with paracetamol on demand, without special care at home.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

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

  • Patient operated for hemorrhoidal disease for 10 or more
  • Age 18 and over
  • Informed patients

排除标准

  • Patient opposition
  • Minor patient

结局指标

主要结局

The rate of recurrence leading to a re-intervention within 10 years of the intervention.

时间窗: 10 years

次要结局

未报告次要终点

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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