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临床试验/NCT03265990
NCT03265990Unknown不适用

Comparison Between Haemorrhoidectomy by Ligasure and Conventional Surgery

Assiut University0 个研究点目标入组 40 人开始时间: 2017年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
主要终点
Post operative pain

研究概览

简要总结

Comparison between Haemorrhoidectomy by Ligasure and conventional surgery

详细描述

Hemorrhoids, a varicose condition are one of the commonest illnesses which causes per rectal bleeding . Hemorrhoidectomy is the standard operation for grades III and IV hemorrhoids; it is superior to any proposed conservative procedure. Conventional haemorrhoidectomy is the open surgical procedure in which the haemorrhoid pedicle is ligated by a transfixing suture which may lead to some postoperative complications mostly pain, bleeding and wound infection which ultimately cause prolonged stay in hospital.

A number of surgeons believe that by avoiding vascular pedicle ligation the chances of secondary bleeding can be decreased .This stimulated the researchers to develop new techniques with a less severe course and faster recovery . Recent advances in instrumental technology including the bipolar electrothermal device, ultrasonic scalpel, and circular stapler are gaining popularity as effective alternatives in hemorrhoidectomy . Of these instruments, the LigaSure vessel sealing system has been recently introduced as a tool conceived to upgrade the conventional treatment of haemorrhoids. This reduces anal spasm and allows performing a bloodless haemorrhoidectomy with reduced post- operative pain and fast healing . .Thus this operation can be recommended as the ideal technique. Many trials were performed to compare LigaSure hemorrhoidectomy with conventional hemorrhoidectomy, although an overall favorable trend exists toward LigaSure, conclusions are not univocal and definitive; this creates some uncertainty, also considering the increasing cost for this disposable device: thus it is essential to keep on experimenting to determine whenever an actual advantage exists.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patients with ages between 18 to 70 years with symptomatic grade III, or IV hemorrhoid who will be operated on at the Department of general Surgery, Assuit University Hospital

排除标准

  • age older than 70 years
  • patients with Grade I and II haemorrhoids
  • patients on anticoagulants
  • patients with liver cirrhosis
  • patients with the hematological disorder
  • patients with the concomitant anal disease
  • patients had previous history of anorectal surgery

研究组 & 干预措施

Group A

Experimental

Conventional haemrrhoidectomy,Ferguson technique

干预措施: Conventional haemorrhoidectomy (Procedure)

Group B

Experimental

Ligasure haemorrhoidectomy

干预措施: ligasure haemroidectomy (Procedure)

结局指标

主要结局

Post operative pain

时间窗: 1 month

pain will be evaluated with visual analogue scale

次要结局

  • Wound healing(2 months)
  • Intra operative blood loss(1 day)

研究者

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

Abdulrahman Refaay Ahmed

araahmed

Assiut University

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