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临床试验/NCT05770141
NCT05770141尚未招募不适用

Laser Hemorrhoidoplasty Procedure Versus Open Surgical Hemorrhoidectomy

Assiut University0 个研究点目标入组 40 人开始时间: 2023年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
主要终点
Pain evaluation

研究概览

简要总结

The study aims to compare the pain , duration of intervention and long term outcomes of laser hemorrhoidoplasty versus open surgical hemorrhoidectomy

详细描述

Hemorrhoidal disease is ranked first among diseases of the rectum and large intestine, and the estimated worldwide prevalence ranges from 2.9% to 27.9%, of which more than 4% are symptomatic .

Age distribution demonstrates a Gaussian distribution with a peak incidence between 45 and 65 years with subsequent decline after 65 years .Men are more frequently affected than women .

The anorectal vascular cushions along with the internal anal sphincter are essential in the maintenance of continence by providing soft tissue support and keeping the anal canal closed tightly. Hemorrhoids are considered to be due to the downward displacement of suspensory (Treitz) muscle .

There are many treatments of hemorrhoids varying from medications and band ligation to stapled hemorrhoidopexy, laser photocoagulation, sclerotherapy, Doppler-guided artery ligation, and finally surgery .

The indications for the surgical treatment include the presence of a significant external component, hypertrophied papillae, associated fissure, extensive thrombosis or recurrence of symptoms after repeated RBL. The technique employed may be open (Milligan-Morgan) or closed (Ferguson) .

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •II-III hemorrhoidal disease
  • •failure of conservative treatment

排除标准

  • •acutely thrombosed haemorrhoids
  • •patients affected by IBD involving rectum or anus
  • •patients previously surgically treated for hemorrhoidal disease and the inability to complete study protocol

研究组 & 干预措施

LHP GROUP

Other

patients received Laser Hemorrhoidoplasty procedure

干预措施: laser hemorrhoidoplasty (Procedure)

MM GROUP

Other

patients received conventional open surgical hemorrhoidectomy

干预措施: open surgical hemorrhoidectomy (Procedure)

结局指标

主要结局

Pain evaluation

时间窗: 30 postoperative days

postoperative pain assessment with Visual Analogue Scale Score, The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

bleeding

时间窗: 30 postoperative days

The timing of bleeding after hemorrhoidectomy varies, and can be generally divided into immediate and delayed.5 Immediate bleeding occurs within 24 to 48 hours of a procedure and is likely related to loss of control of the vascular pedicle. Delayed bleeding is defined as bleeding reported up to 2 weeks postprocedure, and is more often related to infection or local trauma , patients often report frequent passing of small to moderate amounts of clot and bright red blood starting after bowel movement.

次要结局

  • Presence of recurrence(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ebram Nasser Hakim Boules

Doctor

Assiut University

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