DOI: 10.4103/jras.jras_425_25 ISSN: 2456-5601
Comparative evaluation of quality of life in Bhagandara (fistula-in-ano) patients treated with manually and mechanically prepared Ksharasutra: A double-blind randomized controlled trial
Hemanta Panigrahi, Babita Yadav, Amit K. Rai, K. M. Pratap Shankar, Shaizi Layeeq, Anukampa Singh, Arunabh Tripathi, Shruti Khanduri, Bhogavalli Chandrasekhara Rao, Madan Mohan Padhi, Kartar Singh Dhiman, Bharti Gupta, Narayanam Srikanth Abstract
INTRODUCTION:
Ksharasutra
therapy is a minimally invasive parasurgical treatment for fistula-in-ano, known for low recurrence, fewer complications, and simple postoperative care. This study compares the quality of life (QoL), clinical effectiveness, and safety between automated machine-prepared
Ksharasutra
(AMK) and manually prepared
Ksharasutra
(MPK).
MATERIALS AND METHODS:
A total of 100 patients with fistula-in-ano, aged 18–60 years, were randomly allocated to AMK (
n
= 50) or MPK (
n
= 50) groups.
Ksharasutra
was replaced weekly until complete cut-through and healing were achieved. All participants received 6 g
Triphala Churna
orally at bedtime with lukewarm water, along with twice-daily per-rectal
Jatyadi Taila
application and sitz baths. The primary outcome was the change in QoL assessed using the 36-item short form (SF-36) questionnaire. Secondary outcomes included unit cutting time (UCT), total duration to healing, complete healing rate, microbiological culture findings, and treatment-emergent adverse events.
RESULTS:
Out of 100 enrolled patients, 96 completed the study (47 test and 49 control). Both groups showed significant improvement in QoL, especially physical (
P
= 0.025) and emotional health (
P
= 0.035), with overall comparable SF-36 outcomes (
P
< 0.001). Median UCT was 11 days/cm for MPK and 16 days/cm for AMK (
P
= 0.017). All patients achieved complete healing, confirmed through clinical evaluation and magnetic resonance imaging, and no significant differences in microbiological outcomes or adverse events were observed between the groups.
CONCLUSION:
Both manually and machine-prepared
Ksharasutra
were safe and effective in improving quality of life and treating the disease. While unit cutting time differed between the groups, healing and recurrence outcomes were comparable. Machine preparation may offer advantages in standardization, hygiene, and scalability for broader clinical use.
CTRI REGISTRATION:
CTRI/2021/12/038414 (dated December 03, 2021)