Comparative study of standardized apamarga ksharsutra and traditional ksharsutra in the management of bhagandara w . s . r . fistula in ano

Fistula in Ano is condition which has been recognized as difficult surgical diseases in all ancient & modern medical sciences of the world. In Ayurvedic text it is described as Bhagandara. Ksharsutra is a unique and an established procedure for the management of Bhagandara in Ayurveda. It has brought upheaval in the Indian system of Surgery. The aim of the study was to compare standardized or traditional ksharsutra therapy in the management of fistula in Ano. Materials & methodsThe study was randomized clinical trial carried out at anorectal unit of Shalya tantra department of College of Ayurved, Bharati Vidyapeeth Deemed to be University, Pune. The technique involved passing a medicated seton (Ksharsutra) through fistulous tract. 40 patients with fistula in Ano were selected and divided into two groups of twenty patients each. Group A was treated with standardized ksharsutra and Group B with the traditional ksharsutra. ResultThe healing occurred in all patients treated either with standardized or traditional ksharsutra. The average unit cutting time was 5.8 for standardized ksharsutra and 6.7with traditional ksharsutra. Statistical analysis was done. KeywordsBhagandara, fistula in Ano, ksharsutra Introduction (Back ground information) Bhagandara (Fistula in Ano) at modern parlance is a common anorectal condition prevalent in the populations worldwide and its prevalence is second highest after Arsha (hemorrhoids). Fistula in Ano is a tract lined by granulation tissue which opens deeply in the anal canal or rectum & superficially around the anus. 1 Although the four modalities for the treatment of Bhagandara have been described, Kshara is a widely used form. It promises to be an efficient form of treatment 2-5 . Hence this is the field we decided to exploit. In modern science surgery is one of the methods of treating Bhagandara. Kshara Sutra is one Website: http://www.ayurlog.com Volume: 6 | Issue: 5 | August 2018 SPRING / SUMMER EDITION Ayurlog: National Journal of Research in Ayurved Science Impact factor: 2016: 5.210; 2015: 5.223 Established : 2013 ISSN: 2320-7329 Website: http://www.ayurlog.com Volume: 6 | Issue: 5 | August 2018

Fistula in Ano is condition which has been recognized as difficult surgical diseases in all ancient & modern medical sciences of the world. In Ayurvedic text it is described as Bhagandara. Ksharsutra is a unique and an established procedure for the management of Bhagandara in Ayurveda. It has brought upheaval in the Indian system of Surgery. The aim of the study was to compare standardized or traditional ksharsutra therapy in the management of fistula in Ano.

Materials & methods-
The study was randomized clinical trial carried out at anorectal unit of Shalya tantra department of College of Ayurved, Bharati Vidyapeeth Deemed to be University, Pune. The technique involved passing a medicated seton (Ksharsutra) through fistulous tract. 40 patients with fistula in Ano were selected and divided into two groups of twenty patients each. Group A was treated with standardized ksharsutra and Group B with the traditional ksharsutra.
Result-The healing occurred in all patients treated either with standardized or traditional ksharsutra. The average unit cutting time was 5.8 for standardized ksharsutra and 6.7with traditional ksharsutra. Statistical analysis was done.

Keywords-Bhagandara, fistula in Ano, ksharsutra
Introduction (Back ground information) Bhagandara (Fistula in Ano) at modern parlance is a common anorectal condition prevalent in the populations worldwide and its prevalence is second highest after Arsha (hemorrhoids). Fistula in Ano is a tract lined by granulation tissue which opens deeply in the anal canal or rectum & superficially around the anus. 1 Although the four modalities for the treatment of Bhagandara have been described, Kshara is a widely used form. It promises to be an efficient form of treatment [2][3][4][5] . Hence this is the field we decided to exploit. In modern science surgery is one of the methods of treating Bhagandara. Kshara Sutra is one of the chief modalities in the treatment of Bhagandara in Ayurvedic science. [6][7] Exploration of the Standardised ksharsutra as a better substitute to traditional ksharsutra is the need of the hour. The rational of the study is to find out an effective alternative as Standardised preparation of Apamarga ksharsutra over a ksharsutra made by traditional method.
Ksharsutra is a scientifically validated treatment in the management of Bhagandara. Ksharsutra treatment heals the fistulous tract with the integrity of sphincters and the existing data reveal negligible chances of recurrence.
The Apamarga ksharsutra is well proven to be an effective treatment for fistula in Ano, so we decided to use Apamarga ksharsutra manufactured with specially designed machine which provides firm and smooth layered ksharsutra. It has also unique packaging which avoids loss of kshara from ksharsutra.

Need of the study
All previous research was done on various types of ksharsutra and its comparative study and other form of treatment modalities. But here we explored a new manufacturing method for ksharsutra preparation. Its unique trial ever as far as previous study was concerned.
Traditional ksharsutra may loss its coatings and uniformity while packaging. Also may cause infection due to handling. So we decided to use standardized ksharsutra.
CCRAS also prioritized the invention of such ksharsutra made with automated machine.

Aim and Objectives
Aim: 'To evaluate the efficacy of Standardized Apamarga ksharsutra in the management of Bhagandara'.
Objectives: To compare the clinical efficacy of Standardized Apamarga ksharsutra with traditional ksharsutra.

Materials and methodology
The study was randomized clinical trial carried out at OPD/IPD of ano-rectal unit of Shalyatantra department of College of Ayurved, Bharati Vidyapeeth Deemed to be University, Pune. Ethical committee permission was taken prior to study. The technique involved passing a medicated seton (Ksharsutra) through fistulous tract. 40 patients with fistula in Ano (Bhagandara) were selected and divided into two groups of twenty patients each. Group A was treated with standardized ksharsutra and Group B with the traditional ksharsutra Preparation of ksharsutra: Standardized Apamarga ksharsutra prepared with specially designed machine, which gives uniform coating of snuhi latex as well as Apamarga kshara. It also provides unique packaging to avoid loss of kshara from sutra. Traditional ksharsutra prepared according to acharya chakradutta as snuhi and haridra.

Method of ksharsutra Application:-
 Pre-operative preparation  Operative procedure ksharsutra ligation under spinal Anesthesia  Postoperative measures  Ksharsutra Changing on every7 th day after ligation of ksharsutra till cutting of tract.

Selection and exclusion criteria of study participants
Inclusion criteria:-

C} LENGTH OF TRACT
Initially length of tract is measured with the help of probe and length of thread/ksharsutra within the tract then on every follow up length of previous ksharsutra within tract is measured with scale and considered as length of tract.

D} UCT ( UNIT CUTTING TIME)
UCT= Total No. of days taken to cut through / Initial length of tract in cms = Days/cms.

Investigations
Routine hematological, biochemical, urine and stool examinations were done to rule out the pathological conditions mentioned above.

Radiological examinations
1. X-ray chest PA view (if required) 2. Fistulography (in high anal and recurrent fistulae) 3. MR fistulogram (if required and in selected cases)

Follow Up:-
Follow up is taken on 1 st , 7th & 14 th days and observations recorded in a tabular form.      7) Initial length of tract i.e. up to 0-5cm is recorded in maximum 22 patients. . (Table no.7) 8) Maximum UCT in Group A was 7.2 at 9 0 clock position& minimum UCT was 5.3 at 7 0 clock position. 9) Maximum UCT in Group B was 7.5 at 6 0 clock position& minimum UCT was 5.2 at 9 0 clock position.

Conclusion:
Average UCT in group of standardized ksharsutra is 5.8.Average UCT in group of Traditional ksharsutra is 6.7. So results indicates that standardized ksharsutra is statistically more effective than traditional ksharsutra.