| CTRI Number |
CTRI/2021/04/032801 [Registered on: 13/04/2021] Trial Registered Prospectively |
| Last Modified On: |
12/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Research to study the benefits of additional local antibiotic to conservative therapy for healing of painful cuts in back passage |
|
Scientific Title of Study
|
A case control comparative study comparing the benefit of adding local and short term antibiotics to local analgesic and vasodilators in patients of anal fissures |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krishna Gopal |
| Designation |
Additional Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences (IGIMS), Patna |
| Address |
Department of Surgery
Indira Gandhi Institute of Medical Sciences
Sheikhpura
Patna
Patna
BIHAR
800014
India |
| Phone |
8294155575 |
| Fax |
|
| Email |
gopakrishh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Kumar Roy |
| Designation |
Assistant Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences (IGIMS), Patna |
| Address |
Department of Surgery
Indira Gandhi Institute of Medical Sciences
Sheikhpura
Patna
Patna
BIHAR
800014
India |
| Phone |
9801716613 |
| Fax |
|
| Email |
roykanu23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivek Kumar Roy |
| Designation |
Assistant Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences (IGIMS), Patna |
| Address |
Department of Surgery
Indira Gandhi Institute of Medical Sciences
Sheikhpura
Patna
Patna
BIHAR
800014
India |
| Phone |
9801716613 |
| Fax |
|
| Email |
roykanu23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Sciences, Patna (Medical College and Hospital) |
|
|
Primary Sponsor
|
| Name |
Dr Gopal Krishna |
| Address |
Department of Surgery
IGIMS
Sheikhpura
Patna
Bihar 800014 |
| Type of Sponsor |
Other [Self] |
|
|
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 Vivek Kumar Roy |
IGIMS |
Department of Surgery
Indira Gandhi Institute of Medical Sciences
Sheikhpura
Patna
BIHAR |
9801716613
roykanu23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IGIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K602||Anal fissure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2% lignocaine gel with 0.2% nifedipine ointment |
One fingertip unit of each to be applied locally in anus with applicator three times daily for 6 weeks |
| Intervention |
Metronidazole 1% ointment in addition to 2% lignocaine gel with 0.2% nifedipine ointment |
One fingertip unit of each to be applied locally in anus with applicator three times daily for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. patients with clinical diagnosis of anal fissure
2. lesions limited to the epithelium,
3. patients who has pain in the anal region together with ulcers
4. Ulcer in the posterior anoderm without any skin tags
5. Consenting patients willing to voluntarily take part in this study after getting detailed information |
|
| ExclusionCriteria |
| Details |
1. Presumed or confirmed pregnancy
2. Lactating women
3. History of reaction or intolerance to topical agents
4. Associated co-morbidity, such as ischemic heart disease, hypertension,chronic obstructive pulmonary disease, diabetes mellitus, inflammatory bowel disease, HIV- related fissure, tuberculosis ulcer and leukemic ulcer; and associated complications warranting surgery (abscess, fistula, haemorrhoids, and cancer)
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Recovery rate |
3rd week and 6th week of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VAS score |
1st week, 3rd week and 6th week of starting treatment |
|
|
Target Sample Size
|
Total Sample Size="216"
Sample Size from India="216"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
18/04/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Anal fissure is one of the most common presenting complaints in the outpatient departments of general surgery. It is a well-recognized cause of acute anal pain. Although the exact pathophysiology is not yet elucidated but subclinical infection is hypothesized to be associated with chronic anal fissure. In previous studies addition of both oral and local antibiotics to conservative management benefited the patients with both acute and chronic anal fissure. Hypothesis: addition of local antibiotic to conservative management may hasten and improve recovery rate Local vasodilator and analgesic or anaesthetic have proven benefits in both acute and chronic anal fissure. To evaluate whether addition of local antibiotic has any added advantage in terms of recovery and patient’s satisfaction this present study is undertaken.
Patients of acute anal fissure were recruited after obtaining informed consent. Randomized as per allocation sequence done. 68 patients are recruited. |