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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  
AIIMS Bhubaneswar 
 
Primary Sponsor  
Name  AIIMS Bhubaneswar 
Address  Sijua,Patrapada,Bhubaneswar,Orissa 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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