| CTRI Number |
CTRI/2026/02/103070 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To Study that Which Surgery will be best Suited in patients with Complex Anal Fistulas |
|
Scientific Title of Study
|
Prospective Study of Various Surgeries in Complex Anal Fistulas |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anuj Kumar |
| Designation |
Junior Resident |
| Affiliation |
Department of General Surgery LLR Hospital Swaroop Nagar Kanpur |
| Address |
Department of General Surgery
LLR Hospital
Swaroop Nagar
Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
7523841960 |
| Fax |
|
| Email |
kumaranuj22376@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramendra Kumar Jauhari |
| Designation |
Professor |
| Affiliation |
Department of General Surgery LLR Hospital Swaroop Nagar Kanpur |
| Address |
Department of General Surgery
LLR Hospital
Swaroop Nagar
Kanpur
UTTAR PRADESH
208002
India |
| Phone |
7523841960 |
| Fax |
|
| Email |
DR_RAMENDRA@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuj Kumar |
| Designation |
Junior Resident |
| Affiliation |
Department of General Surgery LLR Hospital Swaroop Nagar Kanpur |
| Address |
Department of General Surgery
LLR Hospital
Swaroop Nagar
Kanpur
UTTAR PRADESH
208002
India |
| Phone |
7523841960 |
| Fax |
|
| Email |
kumaranuj22376@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery LLR Hospital
Swaroop Nagar
Kanpur,UP
India
208002 |
|
|
Primary Sponsor
|
| Name |
Department of General Surgery LLR Hospital Kanpur |
| Address |
Department of General Surgery LLR Hospital
Swaroop Nagar
Kanpur,UP India
208002 |
| 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 Anuj Kumar |
LLR Hospital Swaroop Nagar Kanpur |
Department of General Surgery LLR Hospital Swaroop Nagar Kanpur
208002
Kanpur Nagar
UTTAR PRADESH |
7523841960
kumaranuj22376@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GSVMMEDICAL COLLEGE KANPUR |
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 |
| Intervention |
Fistulectomy with or without repair of sphincter |
Fistulectomy with or without repair of sphincter follow up monthly upto 6 months. |
| Intervention |
Laser Surgeries |
Laser Surgeries, follow up monthly upto 6 months. |
| Intervention |
LIFT |
LIFT,follow up monthly upto 6 months. |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Partial Fistulectomy with cutting seton placement |
Partial Fistulectomy with cutting seton placement,follow up monthly upto 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Complex Anal Fistula
(Patients with >30% Sphincter cpmplex involvement,Recurrent Fistula,Patients with High Fistula in Ano,Multiple Fistula in Ano) |
|
| ExclusionCriteria |
| Details |
Patients with Age less than 18 year and more than 65 years,Patients with bleeding disorder,patients with fistula associated with TB,Malignancy,Radiation exposure,and patients with less than 30 percent sphincter complex involvement,and patients not giving consent for surgery. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Healing Time
|
4 Weekly |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incontinence & Recurrence rates |
Monthly up to 6 momnths |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
14/02/2026 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A prospective study of various surgical approaches for complex anal fistula is important because this condition is challenging to treat and is associated with high recurrence rates, risk of incontinence, and significant impact on quality of life. By systematically evaluating different surgical techniques over time, such a study helps identify the most effective and safest treatment options, compare outcomes, complications, and recurrence, and guide evidence-based decision-making. The findings can contribute to standardized management protocols and improved patient outcomes in complex anal fistula. |