| CTRI Number |
CTRI/2020/02/023396 [Registered on: 17/02/2020] Trial Registered Prospectively |
| Last Modified On: |
29/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Compare the study of effect of Partial Fistulectomy with Ksharsutra Ligation and
Ligation of Inter-sphincteric Fistula Tract (LIFT) methods in treatment
of Bhagandara. |
|
Scientific Title of Study
|
Comparative study of Partial Fistulectomy with Ksharsutra (KS) and
Ligation of Inter-sphincteric Fistula Tract (LIFT) methods in management
of Bhagandara. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja D Moje |
| Designation |
PG Scholar |
| Affiliation |
Shri Ayurved Mahavidyalaya Hanuman Nagar Nagpur. |
| Address |
OPD No 8, Shalyatantra department, Shri Ayurved Mahavidyalaya Hanuman Nagar Nagpur.
OPD No 8, Shalyatantra department, Shri Ayurved Mahavidyalaya Hanuman Nagar Nagpur.
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9561558225 |
| Fax |
|
| Email |
poojamoje@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh R Badwe |
| Designation |
proffesor And HOD Department of Shalyatantra. |
| Affiliation |
Shri Ayurved Mahavidyalaya Hanuman Nagar Nagpur |
| Address |
OPD No 8, Shalyatantra department, Shri Ayurved Mahavidyalaya Hanuman Nagar Nagpur.
OPD No 8, Shalyatantra department, Shri Ayurved Mahavidyalaya Hanuman Nagar Nagpur.
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9011060498 |
| Fax |
|
| Email |
dryogesh.badwe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogesh R Badwe |
| Designation |
proffesor And HOD Department of Shalyatantra. |
| Affiliation |
Shri Ayurved Mahavidyalaya Hanuman Nagar Nagpur |
| Address |
OPD No 8, Shalyatantra department, Shri Ayurved Mahavidyalaya Hanuman Nagar Nagpur.
OPD No 8, Shalyatantra department, Shri Ayurved Mahavidyalaya Hanuman Nagar Nagpur.
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9011060498 |
| Fax |
|
| Email |
dryogesh.badwe@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Ayurved Mahavidyalaya,hanuman nagar nagpur. |
|
|
Primary Sponsor
|
| Name |
Shri Ayurved Mahavidyalaya |
| Address |
Hanuman Nagar, Nagpur. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pooja D Moje |
Shri Ayurved Mahavidyalaya. |
Opd no 8, Department
Of Shalyatantra,
Hanuman
Nagar,Nagpur-440024.
Nagpur
MAHARASHTRA |
9561558225
poojamoje@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K605||Anorectal fistula, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ligation of Inter-sphincteric Fistula Tract(LIFT) |
Ligation of Inter-sphincteric Fistula Tract(LIFT)
In this group 30 patients will be subjected to operative procedure.
frequency: once
route:perianal surgery
dose: no drug is used |
| Intervention |
Partial fistulectomy with ksharsutra(KS) |
Partial fistulectomy with ksharsutra(KS)ligation In this group 30 patients will be subjected to operative procedure.
frequency: once
route:perianal surgery
dose: no drug is used |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The patients having inter-sphincteric, trans-sphincteric, supra-sphincteric
fistula in ano.
The patients in age group between 18-60 years. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare partial fistulectomy with ksharsutra (KS) and ligation of
inter-sphincteric fistula tract (LIFT) in healing of Bhagandara.parameters for healing of wound will be taken as perfollowing gradings,
1- complete epithelisation
2-healing with granulation
3-granulation with purulent discharge
4-non healing wound. |
fallow up every 7 days after operative procedure upto 2 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to asses average required time for complete healing of bhagandar in both the method. |
Fallow up every 7 days after operative procedure upto 2 months. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/02/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
study the effect of partial fistulectomy with arka base kshrsutra ligation in the treatment of Bhagandare(fistula in ano)- A Pilot study. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Fistula is chronic infectious condition which is due to cryptoglandular infection characterised by chronic purulent discharge in perianal region. Eradication of sepsis and maintaining continence is aim of management of fistula in ano. In both methods, eliminate the sepsis focii and anal sphincture is preserved so incontinence can be avoided. Fistula in ano does not heal because of two reasons.1.Fecal material can enter the primary opening of tract which causes infection. 2.Inter-sphincteric fistula tract is compressed between internal and external sphincter, causing closed septic foci and persistent sepsis. Ksharsutra is the potent treatment in Bhagandara routinely practiced by ayurvedic surgeons but time period required to cut the tract is too long. Hence now-a-days this procedure is modified as partial fistulectomy with Ksharsutra ligation. In this process core fistulectomy is done up to the sphincter muscle and remaining track is ligated by ksharsutra to avoid the cutting of sphincter muscle at the same time. But to see efficacy of both methods in healing of Bhagandara this topic selected. The present study will reveal which method is beneficial and effective for the treatment of fistula in ano. |