| CTRI Number |
CTRI/2021/03/032286 [Registered on: 24/03/2021] Trial Registered Prospectively |
| Last Modified On: |
23/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The Effect of Topical Application of 5-fluorouracil during Functional Endoscopic Sinus Surgery(FESS) in the prevention of nasal adhesions post-surgery. |
|
Scientific Title of Study
|
The Effect of Topical 5-Fluorouracil Post–Functional Endoscopic Sinus Surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrLekhaa M |
| Designation |
First Year Postgraduate Department of ENT and Head and Neck Surgery SRIHER . |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research. |
| Address |
Room no 22
2nd Floor
OP Block - Department of ENT
Sri Ramachandra Institure of Higher Education and Research
Chennai 600116
Department of ENT
Sri Ramachandra Institute of Higher Education and Research Porur
Chennai 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9600000644 |
| Fax |
|
| Email |
M4420006@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Somu L |
| Designation |
Head of the Department, ENT and Head and Neck Surgery |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research. |
| Address |
Department of ENT
Sri Ramachandra Institute of Higher Education and Research Porur
Chennai 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9600000644 |
| Fax |
|
| Email |
somu_l1496@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrLekhaa M |
| Designation |
First Year Postgraduate Department of ENT and Head and Neck Surgery SRIHER . |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research. |
| Address |
Room 22
OP Block
Department of ENT
Sri Ramachandra Institute of Higher Education and Research Porur
Chennai 600116
Chennai
Department of ENT
Sri Ramachandra Institute of Higher Education and Research Porur
Chennai 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9600000644 |
| Fax |
|
| Email |
M4420006@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Self- Dr.Lekhaa M
Sri Ramachandra Institute of Higher Education and Research Porur
Chennai 600116
Department of ENT |
|
|
Primary Sponsor
|
| Name |
Dr Lekhaa M |
| Address |
Department of ENT
Sri Ramachandra Institute of Higher Education and Research Porur
Chennai 600116 |
| 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 Lekhaa M |
Sri Ramachandra Institute of Medical Education and Research |
Room 22
Department of ENT and head and Head & Neck Surgery
OP Block - G Block
Hospital
SRIHER
Porur
Chennai
Pin 600116
Chennai
TAMIL NADU |
9600000644
M4420006@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee -1 SRIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A488||Other specified bacterial diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
5 FLUOROURACIL |
Route : Topical
Dose : Upon completion of surgery, application of topical 5-FU will be done unilaterally. 1 mL of 5-FU (1000mg/20mL) will be diluted with 9ml of 0.9% saline solution.
1 mL of diluted 5-FU soaked patties will be applied under direct endoscopic visualisation in the nasal cavity. A saline soaked pattie is placed contralaterally.
Frequency : One time application. Contact period of 5 minutes is allowed. |
| Comparator Agent |
Normal Saline |
Normal saline soaked patties which look identical to 5 FU soaked patties will be used in the control nasal cavity.
Route : Topical
Frequency : one time application
Contact period : 5 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients of either age between 18 to 60 years
2 Diagnosis of bilateral chronic sinusitis who have had no relief with maximum medical therapy
3 Similar Lund Makay Scoring on both sides
|
|
| ExclusionCriteria |
| Details |
Revision Endoscopic Sinus surgery
Uncontrolled systemic illness
Known allergy to 5 FU
Pregnancy and lactation
Pre-existing septal perforation or adhesion |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Formation of adhesions post-operatively |
At 2nd 4th and 12th week postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in formation of nasal crusting postoperatively |
At 2nd 4th and 12th week postoperatively |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2021 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Emial principal investigator at lekhaamraj@gmail.com
- For how long will this data be available start date provided 10-09-2021 and end date provided 10-02-2023?
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
|
Functional Endoscopic Sinus Surgery(FESS) is a frequently performed surgery. Formation of post-operative adhesions is a complication that leads to recurrence of disease and need for revision surgery.
5 Fluorouracil is an anti-metabolitic agent that has been shown to reduce adhesions post surgery. In this study, patties soaked in diluted 5-FU will act as the test and patties soaked in Normal Saline will act as the control, placed in one side of the nasal cavity, in a randomized manner, and the formation of adhesions will be studied via serial follow-ups.
Hypothesis : The intra-operative usage of topical 5-FU in the nasal cavity prevents the formation of adhesions and synechiae. |