| CTRI Number |
CTRI/2024/07/070574 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
14/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of silicone stent in endoscopic dacryocystorhinostomy |
|
Scientific Title of Study
|
Comparison of Surgical outcome in endoscopic dacryocystorhinostomy with and without silicone stent: Hospital based 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 |
Dr Mukesh Verma |
| Designation |
PG JR 2 |
| Affiliation |
Government Medical College, Haldwani |
| Address |
ENT Department, 3rd Floor, Dr Sushila Tiwari Hospital, Government Medical College, Haldwani, Nainital, Uttarakhand
Nainital
UTTARANCHAL
263139
India |
| Phone |
7500119282 |
| Fax |
|
| Email |
vmukesh200@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SHAHZAD AHMAD |
| Designation |
Professor and H.O.D |
| Affiliation |
Government Medical College, Haldwani |
| Address |
ENT Department, 3rd Floor, Dr Sushila Tiwari Hospital, Government Medical College, Haldwani, Nainital, Uttarakhand
Nainital
UTTARANCHAL
263139
India |
| Phone |
9634623901 |
| Fax |
|
| Email |
Drshahzadjnmch85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh Verma |
| Designation |
PG JR 2 |
| Affiliation |
Government Medical College, Haldwani |
| Address |
ENT Department, 3rd Floor, Dr Sushila Tiwari Hospital, Government Medical College, Haldwani, Nainital, Uttarakhand
UTTARANCHAL
263139
India |
| Phone |
7500119282 |
| Fax |
|
| Email |
vmukesh200@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Mukesh Verma, ENT Department, Dr Sushila Tiwari Hospital, Government Medical College, Haldwani, Nainital, Uttarakhand 263139 |
|
|
Primary Sponsor
|
| Name |
Dr Mukesh Verma |
| Address |
ENT Department, Dr Sushila Tiwari Hospital, Government Medical College, Haldwani, Nainital, Uttarakhand, India, 263139 |
| 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 Mukesh Verma |
Dr Sushila Tiwari Hospital |
ENT Department, Dr Sushila Tiwari Hospital, Government Medical College, Haldwani, Nainital, Uttarakhand
Nainital
UTTARANCHAL |
7500119282
vmukesh200@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC GMC Haldwani |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H045||Stenosis and insufficiency of lacrimal passages, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Insertion of silicone stent in lacrimal sac |
The study population will be divided into 2 groups of 30 each. Second group will undergo endoscopic dacryocystorhinostomy and silicone stent will be placed in lacrimal sac. Post operatively patency of lacrimal sac and synechiae formation will be assessed |
| Comparator Agent |
no silicone stent placed |
First group will undergo endoscopic dacryocystorhinostomy and no stent will be placed. Post operatively patency of lacrimal sac and synechiae formation will be assessed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with chronic dacryocystitis.
Age more than 18 years.
|
|
| ExclusionCriteria |
| Details |
Patient not giving consent
Age less than 18 years
Revision cases of endoscopic DCR
suspicion of malignancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the patency of lacrimal sac after endosopic DCR with silicone stent and without stent |
1week, 3 week, 6 week and 10 week and 6month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Observe synechiae formation after and other complication of endoscopic DCR with silicone stent and without stent |
1week, 3 week, 6 week and 10 week and 6month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/07/2024 |
| 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 Applicable |
| 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
|
This study is prospective, non randomized, comparative study after approval of institutional Ethical Committee in patients satisfying inclusion criteria planned for endoscopic dacryocystorhinostomy. Material used will be silicone stent, endoscope (30 and 0 degree), Topical anaesthetic agent (LIgnocaine 4% with Adrenaline 1:10,000), Tilleys forcep, Freers elevator, Suction tip, Antifog solution(savlon). The study population will be divided into 2 groups of 30 each. One group will have silicone stent placed in nasolacrimal sac. In the second group, no stent will be placed after Endo DCR. Patency and synechiae formation will be assessed at 1, 3, 6 ,10weeks and 6month. Other complications will also be assessed |