| CTRI Number |
CTRI/2026/02/104511 [Registered on: 23/02/2026] Trial Registered Prospectively |
| Last Modified On: |
15/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARING TWO DIFFERENT PROCEDURES OF CHRONIC FISSURE IN ANO |
|
Scientific Title of Study
|
Randomized control trial on unilateral vs bilateral lateral internal sphincterotomy in a case of chronic fissure in ano |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muthamizh S |
| Designation |
Surgery Resident |
| Affiliation |
AFMC, Pune |
| Address |
B1/13 Maple tower society, Wanowrie
Dept of general surgery, AFMC,wanowrie, Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9445874179 |
| Fax |
|
| Email |
muthamizh44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Animesh vatsa |
| Designation |
Professor |
| Affiliation |
AFMC, Pune |
| Address |
Dept of general surgery, AFMC. Wannourie
Dept of general surgery, AFMC. Wannourie
Pune
MAHARASHTRA
411040
India |
| Phone |
9560495765 |
| Fax |
|
| Email |
animeshvats@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Animesh vatsa |
| Designation |
Professor |
| Affiliation |
AFMC, Pune |
| Address |
Dept of general surgery, wannourie.
Dept of general surgery, wannourie.
Pune
MAHARASHTRA
411040
India |
| Phone |
9560495765 |
| Fax |
|
| Email |
animeshvats@gmail.com |
|
|
Source of Monetary or Material Support
|
| AFMC, Dept of general surgery, wannorie, pune. 411040 |
|
|
Primary Sponsor
|
| Name |
Armed forces medical college |
| Address |
Dept of general surgery, wannourie.411040 |
| 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 Muthamizh S |
Armed forces medical college |
Department of general surgery, AFMC, Wanowrie, Pune. 411040
Maharastra
Pune
MAHARASHTRA |
09445874179
muthamizh44@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee, AFMC, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lateral internal sphicterotomy |
uNILATERAL LIS at 3clk |
| Intervention |
Lateral internal sphincterotomy bilaterally |
Bilateral LIS at 3clk and 9 clk |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All the patients of chronic fissure in Ano for more than 3 months
recurrence in already optd LIS patients
IBD |
|
| ExclusionCriteria |
| Details |
any previous history of rectal and perianal surgeries
Patient with associated complaints of hemarrhoids, fistula in Ano, anal polyp and anorectal prolapse |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the recurrence rate |
03 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare quality of life, post op pain & incontinence |
3 months |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/03/2026 |
| 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 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
|
Gold standard treatment for chronic anal fissure is LIS, which is usually performed at single location, this study compares unilateral vs bilateral open LIS. Anal fissure is a painful linear mucosal tear situated in distal anal canal just below dentate line to anal verge, affects all ages and both sexes. Patient characteristically presently with pain, brigh red bleeding, mucosal discharge and constipation. Injury to anal mucosa by hard stools is the initiating event in the developement of fissure. Fissures classified into acute and chronic and into primary and secondary based on the pathogenesis. Chronicity criteria is duration of symptoms more than 8 weeks, presence of sentinal tag or ulcer with exposed internal sphincter. Aim is to reduce the sphicter tone which in turn increases vascularity, with medical (GTN, CCB, BOTULINUM TOXIN) or surgical intervention(LIS). Internal sphincter is formed by circular muscle fibers, dividing it at one point of the circle relaxes the tone of the sphincter, which is the rationale for doing unilateral LIS. Dividing the sphicter, which is rationale for doing unilateral LIS. Dividing the sphincter at two places relaxes the sphicter effectively and helps in healing faster and recovery. However risk of incontinence may increase. |