To Assess the Efficacy of Video-Assisted Anal Fistula Treatment Versus Ksharsutra Insertion in the Management of Low Anal Fistula: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To evaluate the healing of low anal fistula in Video- Assisted Anal Fistula Treatment versus ksharsutra insertion at 3 months and 6 months after the intervention.
研究概览
简要总结
The proposed study is a prospective randomized control trial to evaluate the efficacy of Video-assisted anal fistula treatment versus ksharsutra insertion in clinical outcomes of the patients suffering from low type fistula-in-ano. The trial will follow the ICMR-GCP guidelines and CONSORT guidelines.
The duration is expected to be two years (including the duration of follow up of 6 month). The study will start from July 2024 after clearance from Institute Ethics Committee from all sites.
All consecutive patients with diagnosis of Fistula-in-ano reporting to OPD of Dept of Surgery at AIIMS will be screened for eligibility criteria and those fulfilling the inclusion criteria will be included in the study. After the confirmation of fistula-in-ano by surgeon on digital rectal examination, proctoscopy and MRI Fistulogram patient will be randomized into 2 groups.
Group I: Video assisted anal fistula treatment group
Group II: Ksharsutra group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants having low anal fistula (subcutaneous, submucosal, inter sphincteric fistula & trans sphincteric with less than 30% involvement of external sphincter) with single tract or multiple small tracts within 2-3 cm of each other and within 5 cm of anal verge diagnosed during clinical evaluation and confirmed by MRI.
排除标准
- •Severely immunocompromised or compromised cardio pulmonary status
- •Participants with uncontrolled comorbidities such as diabetes mellitus and hypertension
- •HIV/hepatitis B/VDRL positive
- •Colorectal carcinoma
- •Ulcerative colitis & Crohn’s patients
- •On anti-tubercular therapy
- •Prior history of anal incontinence
- •High anal fistula
- •Osteomyelitis.
结局指标
主要结局
To evaluate the healing of low anal fistula in Video- Assisted Anal Fistula Treatment versus ksharsutra insertion at 3 months and 6 months after the intervention.
时间窗: 3 months and 6 months
次要结局
- To assess Recurrence at follow up
研究者
Dr Yatin
AIIMS, New Delhi