An Open Label Single Arm Clinical Study To Revalidate Sushrutokta Langalaka Incision Followed By Agnikarma In Vataja Bhagandara

Bhagandara is a condition which has been recognized as a difficult surgical disease in  the ancient and modern medical sciences of the world, because the recurrent nature of this disease which makes it more and more difficult for treatment. The most scientific description about Bhagandara is given in Sushruta Samhita. Bhagandara is a chronic illness which can be co-related to Fistula-in-Ano, though it is not fatal but quite discomforting and troublesome to the patient, it also imposes a psychological stress on the patient.The incidence of Fistula-in-Ano developing from an anal abscess ranges from 26% to 38%, the prevalence rate of  Fistula-in-Ano is 8.6 cases per 100,000 population worldwide. In the men the prevalence is 12.3 cases per 100,000 population and in woman it is 5.6 cases per 100,000 population.Despite of  many advancements in the surgical fields, the treatment of Fistula-in-Ano still remains a great challenge. During the last century, numerous surgical procedures like Fistulectomy, Fistulotomy, Advancement Flaps, Fistula Clip Closure, LIFT technique, VAAFT procedure, Anal Fistula Plug Repair, Fibrin Glue and Seton Techniques, each of these carries significant risk of pain, delayed wound healing, incontinence and re-occurrence.The prime aim of the treatment is to eradicate the tract and drain all collections from the site of infection while preserving anal continence and minimize the re-occurrence. This has led  surgeons to switch to alternative surgical modalities of treatment like Ksharasutra and Agni karma procedures.Even when we go through the classics different varieties of incision has been explained by Acharya Sushruta and Acharya Vagbhata for Bhagandhara.In the management of Vataja Bhagandara  Acharyas have described Chedana karma of interconnected Fistulae with multiple opening using4 types of incisions namely, Langalaka (T-shape), Ardha Langalaka (L-Shape), Sarvatobhadraka (Circular-shape) and Gotirthaka (S-shape).Langalaka means ‘Hal’ i.e. plough used by farmer in field. Theincision have two arm perpendicularto each other and extending on either side like ‘T’ shaped, the interconnected tracts can be easily probed and incised on either side using this Langalaka incision. This emphasizes Acharya Sushruta’s wide knowledge about the disease manifestation, management and complications in *Vataja Bhagandara .*The current Ayurvedic surgical approach for Bhagandara includes Ksharasutra, Partial Fistulectomy and IFTAK. So far, no research work has been carried out to evaluate the efficacy of  Langalaka incision in Vataja Bhagandara. Hence, an attempt will be made to revalidate the Langalaka incision in Vataja Bhagandara.

Sample Size:

The study with a single group consisting of 30 subjects.

Pre-operative procedures:

·       Physical fitness will be taken.

·       Consent will be taken.

·       Subject will be kept NBM 6 hours prior to surgery.

·       Part preparation.

·       Proctoglycerin enema.

·       Injection TT 0.5 ml IM will be given stat.

·       Injection Lignocaine 2% test dose 0.1ml subcutaneous will be given.

Operative procedures:

·       Under Spinal anesthesia with strict aseptic precautions, the part will be painted and draped in lithotomy position.

·       Fistulous tract will be identified and Probed. Length & Direction of the Fistula tract will be noted.

·       ‘Langalaka’ incision (T-shaped)  will be taken over the external opening of the  Fistula track followed by Agni karma usingBipolar Cautery.

·       The same procedure will be carried out for other Fistula tracts.

·       Complete Heamostasis will be achieved.

·       Dressing will be done using Jatyadi Taila.

 Post-operative procedures:

·       Subject will be shifted to post operative ward.

·       Foot end elevation.

·       Restricted head movements will be adviced.

·       The vitals will be monitored every 2 hrly.

·       Catheterization will be done.

·       Oral liquids will be started after 4 - 6 hours of surgery.

·       Tab. Gandhaka Rasayana(2-0-2)A/F

·       Tab Triphala Guggulu (2-0-2)A/F

·       Triphala choorna 20gms HS will be given before food with lukewarm water.