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CTRI Number  CTRI/2024/04/065352 [Registered on: 08/04/2024] Trial Registered Prospectively
Last Modified On: 03/04/2024
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   A Trial to compare treatment with local Steroid Injection Versus Lateral Internal Sphincterotomy in patients with fissure in ano by assessing Pain score and complications 
Scientific Title of Study   A RANDOMIZED CONTROLLED TRIAL TO COMPARE LOCAL STEROID INJECTION VERSUS LATERAL INTERNAL SPHINCTEROTOMY BY ASSESSING VAS SCORE AND EARLY AND LATE POST-OPERATIVE COMPLICATIONS IN FISSURE IN ANO-PILOTSTUDY 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arun Kumar M 
Designation  Assistant Professor (Surgery) 
Affiliation  Armed Forces Medical College 
Address  Assistant Professor (Surgery) Armed Forces Medical College Pune

Pune
MAHARASHTRA
411040
India 
Phone  8668429725  
Fax    
Email  drarunafmc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ashish Kumar Sharma 
Designation  Junior Resident I 
Affiliation  Armed Forces Medical College 
Address  Department of Surgery Armed Forces Medical College Pune

Pune
MAHARASHTRA
411040
India 
Phone    
Fax    
Email  dr.ashishsharma2511@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Arun Kumar M 
Designation  Assistant Professor (Surgery) 
Affiliation  Armed Forces Medical College 
Address  Assistant Professor (Surgery) Armed Forces Medical College Pune


MAHARASHTRA
411040
India 
Phone  8668429725  
Fax    
Email  drarunafmc@gmail.com  
 
Source of Monetary or Material Support  
Armed Forces Medical College, Pune Sholapur Road, Pune, Maharashtra, India Pin 411040 
 
Primary Sponsor  
Name  Armed Forces Medical College 
Address  Pune Sholapur Road Pune 411040 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arun Kumar M  Armed Forces Medical College  Department of Surgery, Main Building, Pune Sholapur Road
Pune
MAHARASHTRA 
9561022299

drarunafmc@gmail.com 
Dr Ashish Kumar Sharma  Armed Forces Medical College  Department of Surgery, Main Building, Pune Sholapur Road
Pune
MAHARASHTRA 
8368107464

dr.ashishsharma2511@gmail.com 
Dr Jafar Husain  Armed Forces Medical College  Department of Surgery, Main Building, Pune Sholapur Road
Pune
MAHARASHTRA 
9673868394

jafarhusain01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, Armed Forces Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K600||Acute anal fissure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Lateral Internal Sphincterotomy   Internal Sphincterotomy as a standard intervention for patients of fissure in ano in one group Duration of Comparator - Single time procedure 
Intervention  Steroid Injection   Steroid Injection to intersphincteric space in Patients of Fissure in ano Duration of treatment - Single injection 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  (aa) 18 years of age or older
(ab) Able to give informed consent
(ac) All patients with chronic fissure in ano 
 
ExclusionCriteria 
Details  (aa) Younger than 18 years old.
(ab) Unable to give informed consent.
(ac) Contraindications for spinal anaesthesia
(ad) patients with other anal conditions – Anal fistula/ hemorrhoids 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
VAS Score  Post operative evening and Day 1 
 
Secondary Outcome  
Outcome  TimePoints 
Short term patient outcomes
[ Time Frame: Measured within one month of the procedure]
To compare the incidence of short term patient complications in percentage among both the groups.
(ab) Long term patient outcomes [ Time Frame: Measured from one month to 6 month of the procedure] 
One month and 6 month 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 3 
Date of First Enrollment (India)   15/04/2024 
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="1"
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  
There has been much debate about the causes of primary anal fissures. Historically, the eliciting factor was considered to be the trauma resulting from the passage of hard feces, but less than 25% of the cases of chronic anal fissures are associated with constipation. Furthermore, many anal fissures of traumatic origin heal whereas others do not. For many years an association with internal anal sphincter (IAS) hypertonia has been evident, although in elderly patients  and in postpartum patients cases of anal fissure have been reported that are associated with a normal or hypotonic IAS. The basal tone of the IAS is affected by various substances, including nitric oxide (NO) . In patients with anal fissures, the synthesis of NO in the IAS is reduced in comparison with the controls . Manometry studies have demonstrated an increased IAS tone and a reduction in anodermal vascular blood flow, mainly in the posterior region  and showed that in patients who benefited from sphincterotomy surgery or from anal stretch sphincter hypertonia was reduced and blood flow increased. This pathogenetic mechanism can explain the achievement of a high rate of healing with medical therapies able to improve blood flow and/or to reduce hypertonia. Triamcinolone injection has been used effectively in levator syndrome and in chronic perianal wounds. Chronic fissure patients present with painful defecation and increase in sphincter tone leading to vicious cycle preventing healing of the fissure in ano. Lateral sphincterotomy which is the gold standard treatment for chronic fissure in ano may lead to post operative complications in the form of hematoma, abscess, fistula and complications of anaesthesia eg. urinary retention. Triamcinolone steroid injection will reduce the inflammation and help in wound healing.

This study will focus on the short and/or long term outcomes following LIS and local triamcinolone injection in chronic fissure in ano.
 
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