| CTRI Number |
CTRI/2024/10/075577 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
19/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between VAAFT vs Ksharsutra |
|
Scientific Title of Study
|
To Assess the Efficacy of Video-Assisted Anal Fistula Treatment Versus Ksharsutra Insertion in the Management of Low Anal Fistula: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yatin |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No 310, Surgery Block, AIIMS New Delhi
Room No 310, Surgery Block, AIIMS New Delhi
New Delhi
DELHI
110049
India |
| Phone |
9654919388 |
| Fax |
|
| Email |
yatin1288@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nelson T |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No 310, Surgery Block, AIIMS New Delhi
Room No 310, Surgery Block, AIIMS New Delhi
New Delhi
DELHI
110049
India |
| Phone |
9789589298 |
| Fax |
|
| Email |
nelson.mbbs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nelson T |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No 310, Surgery Block, AIIMS New Delhi
Room No 310, Surgery Block, AIIMS New Delhi
New Delhi
DELHI
110049
India |
| Phone |
9789589298 |
| Fax |
|
| Email |
nelson.mbbs@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences, New Delhi |
| Address |
All India Institute of Medical Sciences,Ansari Nagar, New Delhi ,110029
|
| Type of Sponsor |
Government 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 Yatin |
All India Institute Of Medical Sciences, New Delhi |
Room No 1, Surgery Unit 6 OPD,Surgery Block
South
DELHI |
9654919388
yatin1288@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH ALL INDIA INSTITUTE OF MEDICAL SCIENCES ANSARI NAGAR, NEW DELHI 110029 Room No 102, 1st Floor Old O.T. Block |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K603||Anal fistula, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
KSHAR SUTRA |
In this procedure after piercing the internal opening, the tip of the probe comes out through the anal canal. Ksharsutra is fixed through the ends of the metal probe and the two free ends of Ksharsutra are tied. Gauze pad dressing will be done and subsequently the thread will be changed once per week. Depending on the cutting and healing of the tract the duration can vary from patients to patients. The process is repeated until the thread cuts open the tract. The total time taken for complete healing of the fistula tract from start of treatment will be noted.
Total Duration 6 Months |
| Intervention |
VAAFT |
Video-assisted anal fistula treatment is
performed with a kit which includes a fistuloscope manufactured by Karl Storz GmbH (Tuttlingen, Germany),
an obturator, a unipolar electrode, an endobrush and 0.5 ml of synthetic cyanoacrylate (Glubran 2Ò—GEM, Viareggio, Italy). The fistuloscope has an 8° angled eyepiece and is equipped with an optical channel and also a working and irrigation channel. Its diameter is 3.3 9 4.7 mm, and its operative length is 18 cm. A removable handle allows easier manoeuvring. The fistuloscope has two taps one of which is connected to a 5,000 ml bag of glycine–mannitol 1% solution, depending on the position of the fistula. Spinal anaesthesia is required. The patient is placed in the lithotomy position. Video-assisted anal fistula treatment has two phases, a diagnostic one and an operative one.
Key steps include diagnostic fistuloscopy, identification of the internal opening, endoscopic treatment of the fistula tract with fulguration, and closure of the internal opening using a 3-0/4-0 proline suture
Total Duration 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Participants having low anal fistula (subcutaneous, submucosal, inter sphincteric fistula & trans sphincteric with less than 30% involvement of external sphincter) with single tract or multiple small tracts within 2-3 cm of each other and within 5 cm of anal verge diagnosed during clinical evaluation and confirmed by MRI |
|
| ExclusionCriteria |
| Details |
1. Severely immunocompromised or compromised cardio
pulmonary status
2. Participants with uncontrolled comorbidities such
as diabetes mellitus and hypertension
3. HIV/hepatitis B/VDRL positive
4. Colorectal carcinoma
5. Ulcerative colitis & Crohn’s patients
6. On anti-tubercular therapy
7. Prior history of anal incontinence
8. High anal fistula
9. Osteomyelitis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the healing of low anal fistula in Video- Assisted Anal Fistula Treatment versus ksharsutra insertion at 3 months and 6 months after the intervention.
|
3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess Recurrence at follow up
To assess Pain on Visual analogue scale
Quality of life (FIQLI) |
3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The proposed study is a prospective randomized control trial to evaluate the efficacy of Video-assisted anal fistula treatment versus ksharsutra insertion in clinical outcomes of the patients suffering from low type fistula-in-ano. The trial will follow the ICMR-GCP guidelines and CONSORT guidelines. The duration is expected to be two years (including the duration of follow up of 6 month). The study will start from July 2024 after clearance from Institute Ethics Committee from all sites. All consecutive patients with diagnosis of Fistula-in-ano reporting to OPD of Dept of Surgery at AIIMS will be screened for eligibility criteria and those fulfilling the inclusion criteria will be included in the study. After the confirmation of fistula-in-ano by surgeon on digital rectal examination, proctoscopy and MRI Fistulogram patient will be randomized into 2 groups. Group I: Video assisted anal fistula treatment group Group II: Ksharsutra group |