1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response (Others) -  Data will be available only if published in peer reviewed journals


6. For how long will this data be available start date provided 01-12-2024 and end date provided 30-06-2025?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - nil

Anal fistula is one of the most prevalent ailments in Ano-rectaldisease associated with long term impact and challenges encountered during its management. The prevalence is greater in men than women, with a rate of 12.3 cases per 100,000 and 5.6 cases per 100,000, respectively. Various emerging treatment modalities areavailable in Ayurvedic as well as contemporary science for fistula- in-ano but none proved to be ideal. Though comparative clinical trials are being done globally for anal fistula but drawback and limitations are associated with every intervention so we are not able to reach the final conclusion that which approach is best for the management of this perplexing disease.

Acharya Sushruta, the father of surgery and the author of Sushruta Samhita has mentioned Kshar Sutra therapy for the management of Bhagandar and it has already been incorporated as standard operating care for anal fistula with least chance of recurrence and incontinence. However, nowadays minimal invasive techniques are gaining more popularity due to its better patient compliance and outcome. Minimal invasive surgery continues to play an important role since it is efficient, safe and is convenient for surgeons as well as patients. MIKST is a novel sphincter saving technique which can yield treatment outcome with lesser duration as compared to conventional Kshar Sutra therapy.

Contemporary science also did a lot of work to propose an ideal treatment for anal fistula and LIFT (Ligation of Intersphincteric fistula tract) procedure is emerging as a good sphincter saving technique.Apart from LIFT, other interventions include fistulectomy, fistulotomy, anal fistula plug, fibrin or cyanoacrylate glue injection, endorectal advancement flap and video-assisted anal fistula treatment. All techniques carry some degree of incontinence and risk of recurrence.Few of these are difficult procedures to perform and require highly experienced surgeons or high-technology equipment. Therefore, here we have planned of this comparative study in Transsphincteric Anal fistula.

This study compares efficacy of all techniques on sameassessment parameters of the disease because till date no comparative study has been conducted using these three modalities i.e; MIKST, LIFT and Standard Apamarga Kshar Sutra therapy.

 

 

 

NEED OF THE STUDY

Nowadays multiple innovative approaches available for the repair of anal fistulae but the best technique is not known and the available evidence suffers from a lack of high quality data with very few large RCTs. Considering tissue preservation and minimalinvasive method, current surgical practice lacks novel modality foranal fistula. Our Ayurveda science also actively contribute KsharSutra application for Bhagandar management in Sushruta Samhita and many studies also conducted in various institutions on this methodology but no any comparative data are available in contemporary as well as Ayurvedic science on these procedures i.e.MIKST, LIFT and Standard Apamarga Kshar Sutra therapy. After arrival of this data, maybe we will give better advise to our societyfor the management of this illness.