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临床试验/CTRI/2024/02/062876
CTRI/2024/02/062876已完成不适用

STAPLED HAEMORRHOIDECTOMY VERSUS OPEN HAEMORRHOIDECTOMY (MILLIGAN MORGAN) FOR GRADE IV HAEMORRHOID

Rohilkhand medical college1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2月27日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
To compare the stapled and open haemorrhoidectomy Milligan morgan in grade 4 haemorrhoid

研究概览

简要总结

Haemorrhoids or piles are the most frequently presenting anorectal disorder. They are considered to be the most common cause of bleeding per rectum1. Piles are symptomatic anal cushions. They are more common when intraabdominal pressure is raised, e.g. in obesity, constipation and pregnancy. Primarily, they occur in the 3, 7 and 11 o’clock positions with the patient in the lithotomy position.2

External haemorrhoids are aggregations of congested inferior haemorrhoidal plexus covered by perianal skin; while, internal haemorrhoids originate from the sub-epithelial plexus of the anal canal above the dentate line3.The symptoms include discomfort, itching, mucous discharge, bleeding, pain, and prolapse associated with a feeling of fullness and incomplete evacuation4. Internal hemorrhoids are classified into 4 grades, Grade I- Prominent haemorrhoidal vessels with no prolapse, Grade II-Prolapse which reduce spontaneously, Grade III- Prolapse and have to be manually reduced, Grade IV- Permanently prolapsed4.

The treatment options for symptomatic haemorrhoids vary from conservative medical management, to various surgical techniques depending on the grade of haemorrhoids. The nonsurgical options include rubber band ligation, injection sclerotherapy, cryotherapy, infrared coagulation, laser therapy, and diathermy coagulation.5 Most nonoperative procedures are reserved for firstand second-degree haemorrhoids. Operative options are clamp and cautery haemorrhoidectomy, open hemorrhoidectomy, closed haemorrhoidectomy, submucosal haemorrhoidectomy, whitehead circumferential haemorrhoidectomy, stapled haemorrhoidopexy, radiofrequency ablation suture fixation haemorrhoidopexy, pile suture’ method, bipolar diathermy haemorrhoidectomy and the LigaSure haemorrhoidectomy. Operative haemorrhoidectomies are reserved mainly for third and fourth-degree haemorrhoids.6

Haemorrhoidectomy is indicated in grade III and grade IV haemorrhoids. Milligan-Morgan open haemorrhoidectomy is the most popular surgical technique in management of 3rd and 4th grade haemorrhoids and is considered the gold standard. However, some early and late post-operative complications like anal pain, acute retention of urine, anal stenosis and incontinence has been reported.

In 1998, Longo provided an initial description for the correction of prolapsed haemorrhoids by applying a circular stapling device. The important concept underlying this technique involved drawing up the haemorrhoidal tissue, and reducing the redundant mucosa, interfering with the branches of the superior haemorrhoidal artery. Patients, therefore, eliminate the painful skin wound. Haemorrhoidal prolapse is corrected by relocating the pile masses into the anal canal and by decreasing the venous engorgement with division of the feeding arteries and redundant mucosa. Through this method, resultant stapled mucosa anastomosis is formed in the rectum, approximately 30 millimetres proximal to the dentate line where sensitive receptors are sparse.

The precise treatment of haemorrhoids is still topic of considerable debate. There are only limited studies on Grade IV Haemorrhoids, which provide evidence comparing the methods of Stapled Haemorrhoidectomy versu

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • All patients of 18 years and above with Grade IV haemorrhoids admitted in the department of surgery of Rohilkhand Medical College and Hospital Bareilly, Uttar Pradesh.

排除标准

  • 1.Patients with colorectal malignancy anal fistula,
  • Acute haemorrhoidal oedema, Perianal sepsis.
  • 3.Patients with acute or chronic diarrhoea or inflammatory bowel disease.
  • 4.Patients with previous history of surgery for haemorrhoids, a pre-existing sphincteric injury, or complete rectal prolapse, or perianal dermatosis.
  • 5.Patients with symptomatic incontinence, diabetes, anaemia, malnutrition, or immunodeficiency; patients with serious heart, liver, or kidney disease, or blood coagulation dysfunction;
  • Pregnant or menstruating.

结局指标

主要结局

To compare the stapled and open haemorrhoidectomy Milligan morgan in grade 4 haemorrhoid

时间窗: 1-After surgery to 10th day | 2-2 weeks after surgery | 3-4 weeks after surgery 4-

次要结局

  • to study demography, time taken for sugery(One year)

研究者

发起方
Rohilkhand medical college
申办方类型
Private medical college

研究点 (1)

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