A clinical trial to study the effect of two different methods of surgery, Ksharsutra ligation and Fibrin Glue application for the patients with Fistula in ano.
- Conditions
- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere,
- Registration Number
- CTRI/2019/06/019915
- Lead Sponsor
- Jyoti Shinde
- Brief Summary
This is a Randomized Controlled Clinical Trial on Integrated approach to the management of low anal fistula with Ksharsutra followed by Cyanoacrylate Glue sealing.In this study Fibrin glue is replaced with the CYNOACRYLATE GLUE. because Fibrin glue was not easily available, there is a high risk of allergic reaction and the cost is too high.On the other hand Cynoacrylate giue is easily available ,has no allergic reaction and cost effective.
Main purpose behind this trial is to explore the basic principal of ’healing of wound in Shuddhavastha". Bhagandat is a chronic and continuously infected tract lined by unhealthy granulation and fibrous tissue.. It is observed in various scientific studies that.all the surgical treatment options for the fistula in ano are carried out in the "Dushtavastha" ie. infected stage of fistula. Sushruta was well aware about wounds and its management. He strongly quoted that there will be delayed or non healing of the wound unless Shuddhavastha of the wound is achieved.
In the present study. total 90 patients were assigned randomly to 3 groups. Patients in group A received Cyanoacrylate glue followed by Ksharsutra therapy. Patients in Group B received Ksharsutra therapy, while patients in group C received Cyanoacrylate glue sealing. All the patients were observed weekly i.e. on 1st, 7th, 14th, 21st day and so on till the complete healing of fistula tract. Effect of the therapy was assessed on the on the basis of relief in subjective as well as objective criteria. Patients were followed up to 6 months after completion of treatment. The observed results were assessed statistically to drive the final outcome..
It was observed that all the therapies were effective in reducing pain, discharge, inflammation and tenderness. Though ksharsutra therapy is 100 % effective in terms of curing the fistula in ano, it took longer duration of time. Also persistent pain and discomfort was observed by the patients during treatment period. But the rate of recurrence was negligible by Ksharsutra therapy.
On the other hand, experimetal group A showed less duration of treatment, early recovery, minimal operative time and hospital stay, pain was comparitively less than other 2 groups. But it was observed that, recurrence was more in group A , as compared to group B., butbit was less than gtoup C.
From this, we can say that, the surgical techniques are adopted in dushtavastha of fistula vrana., which might be the case of recurrence .Finally we can conclude that, ksharssutra ligation until shuddhavastha of vrana, followed by cyanoacrylate glue sealing in comparison to standard ksharsutra therapy can be better ulternative to curtail the prolonged duration of treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 90
- 1.Selection of patients will be done irrespective of sex, religeon,ocupation, economic status and education status.
- 2.The selected patient should have diagnosed as Bhagandara ( Fistula-in-ano ).
- 3.Singal tract with no ramifications, low anal with tract length upto 5 cm to 7 cm.
- 1.Patient suffering from systemic disorders like Tuberculosis, Diabetes Mellitus , Cancer and Immuno-compromised patients.
- 2.Patient with high anal fistula and more than 7 cm tract length.
- 3.Patient suffering from carcinoma of rectum, Hb’SAg and HIV 4.Patient suffering from ulcerative colitis, crohn’s disease and multiple fistula will be excluded from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The subject will be observed on o, 5th,10th, 15t, 20th, 25th, 30th day and so on ie. On every 5 days interval till complete cutting and healing of the fistula tractby Ksharsutra. The subject will be observed on o, 5th,10th, 15t, 20th, 25th, 30th day and so on ie. On every 5 days interval till complete cutting and healing of the fistula tractby Ksharsutra.
- Secondary Outcome Measures
Name Time Method The subject will be observed for the rate and duration of closure of fistula tract until the tract is completely and permanently closed by Fibrin Glue.. The subject will be observed on o, 5th,10th, 15t, 20th, 25th, 30th day and so on ie. On every 5 days interval till complete healing of the fistula tract by Fibrin Glue.. The subject will be observed on o, 5th,10th, 15t, 20th, 25th, 30th day and so on upto the complete debridment (i. e till the stage of Shuddhavastha is acheved). After debridment, the fistulous tract will be sealed with Fibrin Glue.There after,the subject will be observed for the rate and duration of closure of fistula tract until the tract is completely and permanently closed.
Trial Locations
- Locations (1)
Government Ayurved College and Hospital, Nagpur
🇮🇳Nagpur, MAHARASHTRA, India
Government Ayurved College and Hospital, Nagpur🇮🇳Nagpur, MAHARASHTRA, IndiaJyoti ShindePrincipal investigator9975830051drjyoti.dalal@gmail.com