| CTRI Number |
CTRI/2026/02/103945 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing open and closed rhinoplasty techniques in patients undergoing nasal surgery |
|
Scientific Title of Study
|
Comparison of Outcomes Between Open and Closed Rhinoplasty : A Randomised Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
LABHANSHI AGGARWAL |
| Designation |
SENIOR RESIDENT (ACADEMIC) |
| Affiliation |
AIIMS Bathinda |
| Address |
Department of Burns and Plastic Surgery , AIIMS Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
9041253423 |
| Fax |
|
| Email |
lab.lilac@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mohd Altaf Mir |
| Designation |
Head of Department and Additional Professor , Department of Burns and Plastic Surgery , AIIMS Bathinda |
| Affiliation |
Mch Burns and Plastic Surgery |
| Address |
Department of Burns and Plastic Surgery , AIIMS Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
9897561144 |
| Fax |
|
| Email |
draltafmir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
LABHANSHI AGGARWAL |
| Designation |
SENIOR RESIDENT (ACADEMIC) |
| Affiliation |
AIIMS Bathinda |
| Address |
Department of Burns and Plastic Surgery , AIIMS Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
9041253423 |
| Fax |
|
| Email |
lab.lilac@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Bathinda, Mandi Dabwali Road, Bathinda. Punjab - 151001. |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences (AIIMS), Bathinda |
| Address |
AIIMS Bathinda, Mandi Dabwali Road, Bathinda. Punjab - 151001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrLABHANSHI AGGARWAL |
AIIMS Bathinda |
Department of Burns and Plastic Surgery , AIIMS Bathinda , Plastic Surgery OPD , B Block , Room No 2004
Bathinda
PUNJAB |
09041253423
lab.lilac@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, AIIMS Bathinda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Closed Rhinoplasty |
Closed technique of Rhinoplasty
Group B |
| Comparator Agent |
Open Rhinoplasty |
Open technique of Rhinoplasty
Group A |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients of non traumatic nasal septal deviation with nasal deformities
2 Post traumatic nasal deformity
3 Adult patients with post - cleft nasal deformities requiring secondary or definitive rhinoplasty
4 Willingness to undergo either surgical intervention and attend regular follow ups for atleast 6 months postoperatively |
|
| ExclusionCriteria |
| Details |
1 Patients with active nasal infection
2 Patients with nasal skin cancer
3 Patients not willing to participate in the study
4 Patients with co- morbidities such as bleeding disorders, diabetes mellitus, and immunocompromised disorders
5 The patients who had started with the started with the closed technique but then had to undergo the open technique will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Aesthetic outcome following rhinoplasty as assessed using a validated patient-reported outcome measure (Rhinoplasty Outcome Evaluation Questionnaire). |
Baseline (preoperative), 1 month postoperative, and 6 month postoperative. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate duration of procedure and amount of intraoperative bleeding |
Intraoperative |
| To evaluate post operative edema and nasal tip sensation |
1 and 6 months postoperatively |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
25/02/2026 |
| 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 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 - NO
|
|
Brief Summary
|
This study aims to evaluate the aesthetic and functional outcomes in patients diagnosed with nasal deformities presenting to the Department of Burns and Plastic Surgery , AIIMS Bathinda. Patients fulfilling the inclusion criteria will be enrolled after obtaining informed consent. Clinical assessment and relevant investigations will be carried out as per the study protocol. All patients will receive standard treatment according to institutional guidelines. The aesthetic and functional outcomes will be analyzed which may help in optimizing treatment strategies. |