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临床试验/CTRI/2024/10/075342
CTRI/2024/10/075342招募中不适用

A Comparative study of efficacy of Open Haemorrhoidectomy versus Open Haemorrhoidectomy with Internal Sphincterotomy in Management of Haemorrhoids

Bangalore Medical College and Research1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年10月30日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Post operative pain assessed using Visual Analogue

研究概览

简要总结

Hemorrhoids are one of the most common disorders of the anus which are dilated anal cushions occupying 3,7,11Oclock positions .There are various treatment modalities for treatment of hemorrhoids such as open ,closed, stapled ,laser hemorrhoidectomy etc.. But Open Hemorrhoidectomy named after Milligan Morgan is the most commonle performed method in developing nations owing to its ease of procedure and no technical limitations.The main drawback of Open Hemorrhoidectomy is severe post operative pain in the early postoperative period ,others such as bleeding ,urinary retention are also seen.The most important cause for the above complications is spasm of internal sphincter muscle that gets exposed after hemorrhoidectomy.

Studies have shown that adding internal sphincterotomy along with open hemorrhoidectomy significantly reduces post operative complications .Hence my study aims to prove the same .

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients in the above age criteria 2.Patients with clinical and investigations supporting the diagnosis of Grade 3 and Grade 4 Hemorrhoids 3.Patients giving informed consent for surgical excision of hemorrhoids by milligan morgan open hemorrhoidectomy.

排除标准

  • 1.Inflammatory Bowel Disease 2.Fissure in ano 3.Recurrent Hemorrhoids 4.Fistula in ano 5.Malignancy 6.Cirrhosis and Portal Hypertension 7.Pregnancy 8.Patients not giving consent.

结局指标

主要结局

Post operative pain assessed using Visual Analogue

时间窗: Post Operative Day 1 ,Day 2 and Day 3

次要结局

  • Urinary Retention(upto 3 postoperative days)
  • Bleeding per rectum post operatively(pto 3 postoperative days)
  • duration of hospital stay(those staying 3 or less than 3 days or those sgtaying more than 3 days)

研究者

发起方
Bangalore Medical College and Research
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Avulareddygari Ajay Kumar

Bangalore Medical College and Research Institute

研究点 (1)

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