"A comparison in the management of Low Simple Anal Fistula using Fistulectomy and fistulotomy with marsupialization.-A prospective, randomised, comparative study."
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Primary outcome measure - wound healing time.
研究概览
简要总结
Introduction:
Anal fistula are considered one of the commonest cause of persistant seropurulent discharge that irritates the neighbouring skin causing discomfort.Conventional surgical options for a simple anal fistula include a fistulotomy and a fistulectomy.A fistulectomy involves the complete excision of the fistulous tract. A fistulotomy lays open the fistulous tract where in small unepithelized wounds are left open which in turn hastens healing of the wound. Marsupialization of the fistulotomy wounds can reduce the healing time further.The objective of the study is to compare the post operative outcomes using fistulectomy versus fistulotomy with marsupialization in the treatment of low simple anal fistula.
Methodology:
This is a prospective, randomised and comparative study. It is conducted bsed on patients attending General surgery OPD in Imambara District Hospital,Hooghly from April 2016 to March 2017.This study compares the two surgical interventions, Fistulectomy versus Fistulotomy with marsupialization. The primary outcome of measure is the wound healing time and the secondary outcome of measures are the operative tie, post operative wound size, wound infection, post operative pain, recurrence, anal incontinence and patient satisfaction.The ethical clearence is obtained from IEC R.G.Kar Medical college and hospital, Kolkata.The written informed consent is obtained from all the participants prior to the study.The data is collected by using a structured study proforma and is entered into a microsoft excel spreadsheet and then statistically analyzed by SPSS version 24.0 and Graph Pad Prism version 5.
Hypothesis:
In patients with simple anal fistula, the post operative outcomes gained using fistulotomy with marsupialization are better than those gained by fistulectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor 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
- •1.Low trans-sphincteric -fistula tract involving less than the lower third of the anal sphincter.
- •2.A single internal and a single external opening.
- •3.Subcutaneous fistula.
- •4.The absence of a secondary tract.
- •5.Patients consenting for surgery.
排除标准
- •1.Intersphinteric fistula.
- •2.All fistulae due to perineal injuries.
- •3.All congenital fistulae.
- •4.Patients with associated co-morbid conditions such as anal fissure, haemorrhoids, ulcerative colitis, crohns disease, intestinal tuberculosis, growth in anal canal etc.
- •5.Patients with a recurrent fistula.
- •6.Patients refusing to give consent for the surgery.
结局指标
主要结局
Primary outcome measure - wound healing time.
时间窗: for 3 months
次要结局
- Secondary outcome measures - post operative wound size, wound infection, post-operative pain, recurrence, anal incontinence and patient satisfaction.(for 3 months)