| CTRI Number |
CTRI/2024/07/071213 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
a study to compare outcome of nasal surgery in post operative with and without nasal packing |
|
Scientific Title of Study
|
Comparative analysis of septoplasty with and without nasal packing- A Clinical 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 |
Rohit Negi |
| Designation |
ENT PG resident |
| Affiliation |
Government medical College hadwani, nainital. Uttarakhand |
| Address |
ENT department 3rd floor
Dr sushila tiwari
Government medical college, haldwani,Nainital.
Nainital
UTTARANCHAL
263139
India |
| Phone |
7017734442 |
| Fax |
|
| Email |
rnegi412@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shahzad Ahmad |
| Designation |
Head of department, Professor in Department ofENT |
| Affiliation |
Government medical college, haldwani |
| Address |
Room no. 1 3rd floor ENT department office Dr sushila Tiwari government hospital, haldwani, NAINITAL
Nainital
UTTARANCHAL
263139
India |
| Phone |
9634623901 |
| Fax |
|
| Email |
Drshahzadjnmch85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shahzad Ahmad |
| Designation |
Head of department, Professor in Department ofENT |
| Affiliation |
Government medical college, haldwani |
| Address |
Room no. 1 3rd floor ENT department office Dr sushila Tiwari government hospital, haldwani, NAINITAL
UTTARANCHAL
263139
India |
| Phone |
9634623901 |
| Fax |
|
| Email |
Drshahzadjnmch85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Sushila tiwari government medical hospital haldwani, Nainital, uttarakhand, India
263139 |
| Self (Dr Rohit Negi) |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [No any sponsor] |
|
|
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 ROHIT NEGI |
Dr Sushila Tiwari government hospital haldwani |
ENT department 3rd floor Dr Sushila Tiwari government hospital haldwani NAINITAL
Nainital
UTTARANCHAL |
07017734442
rnegi412@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Septoplasty |
Septoplasty done in all cases, but nasal packing done in one group and not done in 2nd group will be done in period of 18 months on sample size 110 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with symptomatic DNS.
|
|
| ExclusionCriteria |
| Details |
Guardians not giving consent.
Lost to follow up
Revision surgery
Comorbidities present |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain and discomfort immediately after post op period. |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post op nasal obstruction. |
2 week |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
20/08/2024 |
| 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 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
|
1. This type of study has not been done in Kumaon region. 2.To find alternative for post op nasal packing which cause pain and discomfort in post op period 3. To compare post operative pain in both the groups. 4. To compare the post operative nasal obstruction in both groups. 5. To compare the post operative bleeding in both groups.
|