Clinical trial NCT01880398: Management of Fistula in Ano by Kshar Sutra, Para Surgical Procedure.
Official title: Case Study of Fistula in Ano Managed by Kshar Sutra, Para Surgical Procedure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fistula in Ano
Keywords: FIstula in ano; Bhagandar
Lead sponsor: Government Ayurved College and Hospital
Sponsor class: OTHER_GOV
First posted: 2013-06-19
Enrollment: 1
Sex: FEMALE
Minimum age (years): 48
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Government Ayurved Hospital

Brief summary: Background: Fistula in ano is one of the most common diseases of the ano rectal region. Treatment of Fistula in ano has puzzled the medical fraternity due to its complex nature. Commonly prevalent surgical treatment for anal Fistula, that is "Fistulectomy" does not provide successful cure for the disease, post operative complications and recurrences being common. Acharya Sushruta an ancient Indian Surgeon has described in his text ' Sushruta Samhita' about an ancient Ayurvedic technique of medicated thread called Ksharsutra treatment for Bhagandara ( Fistula in ano). Treatment of anal Fistula (Bhagandara)and Nadi-Vrana(Sinus) with Ksharsutra was practiced by Sushruta (1000-600B.C.) .

Hypothesis: Aycharya Sushruta advocated Kshar Sutra therapy in Fistula in ano and in various types of Fistula.

Detailed description: A 48 years old female patient, came with complaints of painful discharging boil at left side of Perianal region with pain.

She gave a surgical history of incision and drainage for gluteal abscess done in before four month. On local examination Patient had discharging sinus at 3 o' clock position on left side of Perianal region. Before planning the treatment other aetiologies were ruled out.

Diagnosis was confirmed by Fistulogram, suggestive of high anal fistula with internal opening in the anal canal. Under spinal anaesthesia probing was done. Internal opening of Fistula was confirmed by injecting Methylene Blue dye through external opening. The track was directed upward in the anal canal without any tributaries. Length of the tract was 9cm.

Then Kshar Sutra was tied covering the entire underlying track for cutting and healing under all aseptic precaution. The patient was discharged on the next day of procedure. The Kshar Sutra was changed weekly. To promote healing and to reduce pain and inflammation oral antibiotics, anti-inflammatory medicine were also prescribed.

The total period of Kshar Sutra treatment was 5 month. The Kshar Sutra was a standard medicated thread smeared with Kshar of Apamarga (Achyranthus aspera), Shnuhi (Eforbia Nerrifolia) which has quality of cutting and Haridra(Curcuma Longa) which is used as a antiseptic. The ph value of the thread thus prepared was determined and its sterilization effected by ultraviolet rediation. The alkalinity of Kshar Sutra was 9.2ph.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Fistula in ano without tributeries.

Exclusion Criteria:

* Multiple fistula and associated ano rectal conditions

Primary outcomes:
measure: Efficacy of Kshar sutra in Fistula in ano
timeFrame: 5month
Secondary outcomes:
measure: Recurrence of Fistula in ano
timeFrame: 1year
Other outcomes:
Locations:
city: Nagpur
country: India
facility: Government Ayurved Hospital
state: Maharashtra
Study officials:
affiliation: Government Ayurved Hospital
name: Nita M Kedar, M.S.(Ayu)
role: PRINCIPAL_INVESTIGATOR
References: