Evaluation of fistulous tract by histo pathological study on the efficacy of Ksharasutra in Fistula in ano
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Complete healing of the peri anal fistula with healthy granulation tissues in the histo pathological specimens
研究概览
简要总结
A track with epithelial lining that connects the anal canal to the perianal skin is known as a fistula-in ano. Anorectal abscesses are the most frequent cause of anal fistulas, while they can occur for a varietyof reasons. Men experience the prevalence at a rate of 12.3 cases per 100,000 and women at 5.6instances per 100,000 respectively. The majority of diagnoses happen between the ages of 20 and 40,with a 38-year-old average. Obesity, diabetes, smoking, hyperlipidemia, and a sedentary lifestyle arerisk factors for fistula formation. Sushruta discussed the genesis, clinical appearance, and therapy ofBhagandara. The description of several varieties of Bhagandara (fistula-in-ano) is comparable to theaetiopathogenesis of Fistula-in-ano as it is understood by contemporary medical research. It is a verycomplex illness brought on by a number of causes including inflammatory bowel disorders likeCrohn’s disease and ulcerative colitis, as well as pyogenic, tubercular, lymphogranuloma inguinale,and others. This is a condition where there is a need of invasive surgical interventions likeFistulectomy, LIFT, Fistulotomy, VAAFT etc. which are costly, risk-bearing and needhospitalization. The chances of recurrence after these surgeries are also high and development ofcomplications like fecal incontinence are also seen after these invasive procedures. Kshara Sutra is apara surgical intervention mentioned in Ayurveda classics to treat Fistula in Ano which is a minimallyinvasive and cost-effective treatment with a very low chance of recurrence and carries minimal amountof risks. The efficacy of Kshara Sutra in Fistula In Ano has been studied and proved from time totime, but no study has been conducted to understand the action of Kshara sutra on the tract on a cellularlevel. Hence in order to study and understand the action of Kshara sutra on a cellular level thisHistopathological study is being conducted. Tissue from the tract of the fistula-in-ano can bestudied histo-pathologically to determine the efficacy of Kshara Sutra treatment. In this study, a biopsy will be taken from the fistulous tract at regular intervals and histopathological changeswill be observed to determine the action of Kshara Sutra and its mechanism in the healingprocess
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients having Fistula in Ano.
- •Patients fulfilling the diagnostic criteria.
- •Patients who have signed the written informed consent.
排除标准
- •Patients suffering from:- 1) All infectious diseases 2) All Malignancies 3) Rectal polyps 4) Rectal prolapse 5) Uncontrolled diabetes mellitus and Hypertension Anemia 6) Congenital anomalies of the anus and rectum 7) History of acute bleeding 8) K/C/O Ulcerative colitis and Crohn’s disease.
- •Pregnant And Lactating Women.
结局指标
主要结局
Complete healing of the peri anal fistula with healthy granulation tissues in the histo pathological specimens
时间窗: 6 weeks
次要结局
- Complete healing of the fistula tract with healthy granulation tissues in the histo pathological specimens(3 weeks)
