To compare treatment of Fistula in Ano (Bhagandar)by ksharsutra( medicated thread) and laying open of fistula tract with kshar application(Alkaline Herbal paste)

Phase 1

Completed

• Conditions: Anal fistula, diagnosed case of Low Fistula in Ano,

• Registration Number: CTRI/2017/03/007980
• Lead Sponsor: Institute for Post Graduate Teaching And Research In Ayurveda

Brief Summary

In clinical study, patients of Bhagandara were selected and randomly allocated using computerised randomisation table into two groups. In Group- A (n=53) patients were treated by Fistulotomy with Kshara application, while in Group-B (n=53) patients were treated with Ksharsutra application. In both groups adjuvant treatment was Varuna Shigru Guggulu vati 1gm TDS, Panchvalkal kwath for sitz bath BD and Jatayadi tail matrabasti once in a day was given till completion of treatment. For that purpose selected patients were subjected to detailed history taking on the basis of specially prepared performa. Routine haematological biochemical, urine and stool examinations were carried out before the treatment for preoperative assessment and fitness. Pre Operative and Post operative TRUS (Trans rectal ultrasonograph ) was done for evidence of healing of fistula. The postoperative treatment was similar in both groups. In Group A dressing was done with Kshar plota (gauze dipped in ksharjala) till the post operative wound had slough on it, followed by dressing with gauze socked in normal saline. In Group B the tract was flushed with Ksharjala every day and Ksharsutra was changed by rail road method every week till the Ksharsutra got cut through.

The effect of the therapies was assessed on the basis of relief in subjective criteria (pain, discharge and itching) and assessment of objective criteria i.e Lenth of Ksharsutra in group B and Length of post operative wound in Group A. Followup was taken after 1 month of healing of post operative wound and post operative TRUS was done. The observed results in the study were assessed statistically to derive final results.

102 out of 106 patients of two groups had completed the treatment and 4 dropped out from study for personal reasons (One patient dropped out from Group A while 3 patients dropped out from Group B).



OBSERVATIONS:

Observation made in the clinical study are summarised as follow

ï‚· In this study maximum patients were male (88.7), in the age group of 41 to 50 years (33.9%) and married (83.9 %).

ï‚· The patients belonged to urban habitat were 65%

ï‚· Maximum patients had vegetarian diet 60.4%

ï‚· 72.6% belonged to middle class

ï‚· 88.7% belonged to Hindu religion while others were muslim.

ï‚· In cardinal symptoms maximum patients had complain of pain (93.4%) followed by discharge (83%).

ï‚· Maximum numbers of patients reported the Chronicity early duration that 0-3 months (42.4% )

ï‚· Single external opening was found in 86.8% and the initial length of tract up to 4cm in 88.7% was observed in maximum patients.

 In most of the cases external openings were found at 6 o’clock position (32% ). That is posterior half of anus.

ï‚· The complete low anal type of fistula-in-ano were found in maximum patients (89.6%) out of which 40.6 % had Intersphincteric fistula and Transphincteric Fistula



RESULT



 Comparison of mean change in pain score from before to after treatment periods showed that there was significant (p=0.0001) mean change in pain score in both the groups. However, the mean change in pain score was higher in Group A (3.64±2.06) than Group B (3.22±2.41).

ï‚· The comparison of mean pain score between the groups across the time periods showed that pain score was significantly (p<0.05) different at most of the time periods ( 1st week, 2nd week, 3rd week, 4th week, 5th week, 6th week and AT).



ï‚· The comparison of improvement in pain, discharge and itching between the groups from before treatment to at the end of treatment showed that pain was improved in 96.1% patients of Group A and 96% of Group B. Discharge was improved in 100% patients of Group A and 96% patients of Group B. Itching was improved in 98.1% patient of Group A and 94% patient of Group B.

 The comparison of time taken for wound healing between the groups showed that time of healing was significantly (p=0.004) lower among the patients of Group A (4.80±2.42) than Group B (4.80±2.42).

ï‚· In Group B, Mean Unit Cutting Time was 7.45 days/cm



Overall Effect Of Therapy



The comparison of overall improvement between the groups. Complete healing was among 90.6% of Group A and 75.5% of Group B. There was no significant (p>0.05) difference in healing between the groups.

DISCUSSION:

In the research work 88.7% patient were in their fourth decade of life and there was significant male predominance which is in accordance with the other studies in India and world. Most patient belonged to urban habitat and hindu religion as Jamnagar is hindu dominant city.

The relative distribution of Intersphincteric and transsphincteric fistulae is also consistent with the previous studies. (Sainio P etal) In most of the cases external openings were found at 6 o’clock position (34.9% ). That is posterior half of anus. Posterior wall of anal canal is more fixed to surrounding musculature than anterior wall. Another cause might be due to fixity of posterior wall there is more chance of stagnation of infection, which infects an anal gland of posterior wall. In classics it is mentioned that the anal glands are 4-8 in number and most of them are situated at posterior portion of anal canal.

Early relief in pain, discharge and itching was observed in Group A compared to Group B but no significant difference was seen in the criterias after treatment which may be because in Group B there is constant cutting and debridement of fistulous tract during treatment which results into pain and dicharge.



The mean duration of healings of fistula is less in Group A compared to Group B clearly indicated that in the trial group ( Fistulotomy with Ksharkarma) healing time is earlier as compared to Group B which may be because most of the unhealthy granulation tissue is removed during fistulotomy and what is left is debired by the Tikshna Kshara. Fistulotomy helps in complete drainage of the fistulous tract and abscess cavity and Tikshna Kshara debrides the unhealthy granulation and fibrous tissue at the base of the tract. It also cauterizes the branches which may be left undetected, thus preventing recurrence.

While in Group B the healing time is delayed as compared to Group A might be as the tract is cut by the Ksharsutra and there is delayed healing of wound after cut through, because Ksharsutra is a foreign material for the body so there is hypergranulation after the cut through of Ksharsutra. Thus, healthy granulation takes time to develope and therefore the healing of post Ksharsutra wound is delayed.

The adjuvant therapy was similiar in both groups. Panchvalkal kwath sitz bath helped to clean the pus discharge and associated debris from the tract and promoted drainage of pus from the tract. It helped to reduce local congestion and inflammation and thus relived associated pain by enhancing local circulation which is necessary to promote healing and oil itself is vatashamak in nature so reduces pain and it also lubricates the anal canal preventing constipation, eases the passage of stool and promotes wound healing. Varuna shigru guggulu has antibacterial and anti inflammatory properties so reduced pain and prevented infection

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-03
• Study Completion: 2018-09-17
• Last Update Posted: 2020-12-07

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Diagnosed cases of Low anal Fistula.
• Patients of Bhagandar, as mentioned above, and those medically fit for surgery irrespective of sex, caste, religion & occupation.

Exclusion Criteria

Crohns disease Uncontrolled Diabetes Melitus Uncontrolled Hypertention Cardiovascular disease Pregnancy Malignancy Rectal prolapse Hepatitis B, Tuberculoses, HIV & VDRL positive cases.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
healing of fistulous tract	healing of fistulous tract and post operative wound size

Secondary Outcome Measures

Name	Time	Method
Not Applicable	Not Applicable

Trial Locations

Locations (1)

Institute of Postgraduate training and Research in Ayurveda; 🇮🇳 Jamnagar, GUJARAT, India

Institute of Postgraduate training and Research in Ayurveda

🇮🇳Jamnagar, GUJARAT, India

Dr Monica Shrestha

Principal investigator

8422913401

SHRESTHAMONICA33@GMAIL.COM