| 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
|
|
|
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
|
|
|
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. |