| CTRI Number |
CTRI/2022/04/041736 [Registered on: 08/04/2022] Trial Registered Prospectively |
| Last Modified On: |
31/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [BEST technique will be used] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to evaluate safety of BEST surgery in complex fistula |
|
Scientific Title of Study
|
A Prospective Non-comparative Study to evaluate the efficacy and safety of BEST Balloon Expansion and Separation Technique Surgery by using special tube drain called as BEST device in all types of complex fistula
in ano |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HHCRS/BEST/006/V1.0/4/3/2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashwin Porwal |
| Designation |
Principal Investigator |
| Affiliation |
Healing Hands Clinic |
| Address |
Millenium Star extension adjcent to ruby hall dhole patil road pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9822347770 |
| Fax |
|
| Email |
drashwinporwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwin Porwal |
| Designation |
Principal Investigator |
| Affiliation |
Healing Hands Clinic |
| Address |
Millenium Star extension adjcent to ruby hall dhole patil road pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9822347770 |
| Fax |
|
| Email |
drashwinporwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwin Porwal |
| Designation |
Principal Investigator |
| Affiliation |
Healing Hands Clinic |
| Address |
Millenium Star extension adjcent to ruby hall dhole patil road pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9822347770 |
| Fax |
|
| Email |
drashwinporwal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Healing Hands Clinic |
| Address |
Millenium star extension adjcent to ruby hall dhole patil road pune |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Ashwin Porwal |
Healing Hands Clinic |
Third Floor Millenium star extension adjcent to ruby hall dhole patil road pune 411001
Pune
MAHARASHTRA |
9822347770
drashwinporwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Healing Hands IEC |
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 |
| Intervention |
BEST Device |
Balloon Expansion & Seperator Technique used.Balloon kept for 2-3 weeks. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18-80 years
Patients with all types of complex fistula
fistula associated with multiple tracts
horse shoe fistulas
Recurrent fistulas
anterior fistulas in females
fistula with long tracts
Fistula with supralevator blind extension
fistula where internal opening cannot be localised
fistula associated with abscess or pus collection |
|
| ExclusionCriteria |
| Details |
Uncomplicated fistula cured by simple fistulotomy
history of inflammatory bowel disease
Chronic immunosuppresive treatment
untreated cancer or cancer treated or dignosed within 6 months
Incompetent subject
pregnancy
any clinical condition,according to the investigator which does not allow safe fulfillment of the study protocol |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluate the time to heal anal fistula
Evaluate and compare VAS pain score
To evaluate anal fistula recurrence rate
|
6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To correlate preoperative endoscopic findings with intraoperative findings
To determine length of hospital stay
To determine incidence of postoperative complications |
7 day,15 day,1 month,3 month,6 months,12 month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/04/2022 |
| Date of Study Completion (India) |
10/05/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A prospective,non comparative,single center, study to evaluate the efficacy and safety of BEST (Balloon Expansion And Seperator Technique) surgery by using special drain tube called as BEST device in all types of complex fistula in ano. Total 50 patients to be enrolled in study including patients suffering from complex fistulas.Study duration will be 12 months for each patients. ICF will be given on time of screening. Pre-operatve details regarding demographics,clinical findings,diagnostic imaging will be recorded. Intraoperative settings & findings will be noted.Post operative course including complications,hospital stay,recurrence.etc.will be recorded.Patients will be followed up at 1,3,6 & 12 month duration.Follow up taken will be based on questionnaires(Wexner fecal Incontinence Score and VAS pain score).Recurrence will be noted at a minimum of 12 month follow up. |