| CTRI Number |
CTRI/2024/05/066830 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the efficacy of cyanoacrylate glue with standard treatment modalities in anal fistula |
|
Scientific Title of Study
|
Efficacy of cyanoacrylate glue versus fistulotomy in the management of simple low anal fistula in tertiary care hospital - A Randomised Controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kumaravel |
| Designation |
Post graduate student |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of general surgery
Pondicherry institute of medical sciences
Ganapathichettikulam
Kalapet
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9790051660 |
| Fax |
|
| Email |
drkumaravel26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Peter Manoharan chellappa |
| Designation |
Professor |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of general surgery
1st floor
OPD extension block
Pondicherry Institute of Medical Sciences
Ganapathichettikulam
Kalapet
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9447591100 |
| Fax |
|
| Email |
peternirmala@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Peter manoharan chellapa |
| Designation |
Professor |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of general surgery
1st floor
OPD extension block
Pondicherry Institute of Medical Sciences
Ganapathichettikulam
Kalapet
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9447591100 |
| Fax |
|
| Email |
peternirmala@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Pondicherry Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Kumaravel |
| Address |
Room no 225
2nd floor
PG boys hostel
Annexe block
Pondicherry Institute of Medical Sciences campus
Ganapathichettikulam
Kalapet
Puducherry 605014 |
| 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 Kumaravel |
Pondicherry Institute of Medical Sciences |
Department of general surgery 1st floor
OPD Extension building
Ganapathichettikulam
Kalapet
Pondicherry
PONDICHERRY |
9790051660
drkumaravel26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS INSTITUTE ETHICS COMMITTEE |
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 |
| Intervention |
Cyanoacrylate glue application |
Patient will be given 1-3ml of cyanoacrylate glue (depending upon the length of fistula) via 8F infant feeding tube loaded in syringe into the fistula tract til internal opening is reached and glue will be injected gradually. Patient will be followed up after 24 hours of surgery, after 2 weeks and once a month for 2 months. The wound healing time will be assessed after 3 months of follow up period.
The total duration of intervention is for 3 months |
| Comparator Agent |
Fistulotomy |
Pateint will undergo surgical procedure such as lay open of the fistula tract as a complete transection between the fistula tract and anoderm. The tract will be taken out of the surrounding tissue and will be incised into the subcutaneous tissue. Patient will be followed up after 24 hours of surgery,after 2 weeks and once a month for 2 months.The wound healing time will be assessed after 3 months of follow up. The total duration of intervention is for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patient undergoing simple low anal fistula surgeries |
|
| ExclusionCriteria |
| Details |
1)Complex and high anal fistula
2)Diabetes mellitus |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of wound healing |
24 hours,2 weeks,1 month,2 months, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Post operative pain
2)Duration of hospital stay
3)Maintenance of anal continence |
24 hours,2weeks,1month,2 months,3 months |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
14/05/2024 |
| 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="10"
Days="16" |
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drkumaravel26@gmail.com].
- For how long will this data be available start date provided 01-11-2026 and end date provided 31-10-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
SUMMARY OF PROTOCOL
Objective: To compare the duration of wound healing between cyanoacrylate glue application and fistulotomy in patients with simple low anal fistula. The secondary outcome measured are Post operative pain, Duration of hospital stay, Maintenance of anal continence. Materials and methods: This Randomized control study design includes patients above 18 years of age with simple low anal fistula. Exclusion criteria are complex and high anal fistula and Diabetes mellitus. After Computer generated block randomization, two groups with 28 study participants in each group will be allocated. Group A will undergo fistulotomy. Group B will receive 1-3 ml of N-butyl cyanoacrylate glue in to the fistula tract. After 24 hours, patient will be discharged and will be followed up every 2 weeks for one month and monthly once for 2 months. Data will be collected in the predesigned case report form and following measuring tools will be used 1)Complete healing (epithelization) at 24 hours after surgery, at time of discharge,1st,2nd,3rd month 2)Pain will be assessed before intervention and at 24 hours after surgery, at time of discharge,1st, 2nd,3rd month using Visual analog scale 3)Post operative incontinence to Gas/Liquids/solids at 24 hours, after surgery, at time of discharge, 1st, 2nd, 3rd month will be measured using The Wexner score All the collected data will be entered in a Microsoft Excel sheet and will be analyzed using SPSS software and categorical data will be expressed in percentage or number and will be measured using Chi-square test. All numerical data will be expressed as mean and standard deviation and measured using independence t test. P value <0.05 will be considered as significant. |