| CTRI Number |
CTRI/2020/08/027319 [Registered on: 21/08/2020] Trial Registered Prospectively |
| Last Modified On: |
05/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
FIPS vs LIFT for Fistula in ano |
|
Scientific Title of Study
|
FIPS vs LIFT for Fistula in ano- A double-blind randomized controlled trial(FILIP trial) |
| Trial Acronym |
FILIP trial) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pankaj Kumar |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
AIIMS Bhubanesawr |
| Address |
Room No 402,Academic Block,
AIIMS Bhubaneswar,
Sijua,Patrpada
Khordha ORISSA 751019 India |
| Phone |
9438884253 |
| Fax |
|
| Email |
drpkushwaha@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pankaj Kumar |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
AIIMS Bhubanesawr |
| Address |
Room No 402,Academic Block,
AIIMS Bhubaneswar,
Sijua,Patrpada
ORISSA 751019 India |
| Phone |
9438884253 |
| Fax |
|
| Email |
drpkushwaha@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Pankaj Kumar |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
AIIMS Bhubanesawr |
| Address |
Room No 402,Academic Block,
AIIMS Bhubaneswar,
Sijua,Patrpada
ORISSA 751019 India |
| Phone |
9438884253 |
| Fax |
|
| Email |
drpkushwaha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Bhubaneswar |
| Address |
Sijua,Patrapada,Bhubaneswar,Orissa |
| 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 Pankaj Kumar |
AIIMS Bhubaneswar |
Sijua,Patrapada,Bhubaneswar Khordha ORISSA |
9711090814
drpkushwaha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K628||Other specified diseases of anus and rectum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fistulotomy and Primary sphincteroplasty(FIPS) |
Fistula in ano operated by Fistulotomy and Primary sphincteroplasty(FIPS) |
| Comparator Agent |
Ligation of intersphincteric fistula tract(LIFT) |
Fistula in ano operated by Ligation of intersphincteric fistula tract(LIFT) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All the patient with Fistula in ano of cryptoglandular origin and age >18 years |
|
| ExclusionCriteria |
| Details |
Multiple, recurrent fistula, Patients with comorbidities |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incontinence rate between FIPS and LIFT for Fistula in ano. |
One month and six month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| postoperative pain,quality of life,complications |
6 months |
|
|
Target Sample Size
|
Total Sample Size="146" Sample Size from India="146"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/08/2020 |
| Date of Study Completion (India) |
Date Missing |
| 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
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ligation of intersphincteric fistula tract has gained popularity in the last ten years as sphincter preserving surgery for Fistula in ano.The success rate varies between 50-90% in different studies.The wide variation in success rate is attributed to variation in surgical techniques by the surgeons around the world.Another important cause of recurrence is a failure to identify the secondary tracts. Fistolotomy or fistulectomy is a gold standard procedure for low Fistula in ano, with minimal risk of incontinence and very low recurrence. However, for high Fistula in ano, this age-old procedure was not adopted because of the high incidence of faecal incontinence. The primary factor related to the incontinence is a division of fibres of the external sphincter. Combining sphincteroplasty to fistulotomy or fistulectomy has shown excellent outcome in some recent studies. The only significant drawback is the risk of incontinence. The rate of incontinence reported in littérature is as high as 16%. In contrast, the rate of incontinence reported with LIFT is as low as 1.6%. However, our internal audit of patients operated for Fistula in ano by Fistulotomy and Primary sphincteroplasty(FIPS) have meagre incontinence rate and good outcome of over 90%. The incontinence observed in a few patients were mild and improved over time. Our success rate with LIFT in our setup is above 85% with minimal incontinence of 1%. No study has compared these two procedures. Hence, to determine the outcome and the incontinence rate with these two procedures, we propose this randomized controlled trial. |