| CTRI Number |
CTRI/2024/10/074830 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
06/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
“Comparison of Two Surgical Methods to Treat Blocked Noses Caused by Deviated Septum: Traditional vs. Endoscopic Surgery†|
|
Scientific Title of Study
|
a comparative study of endoscopic septoplasty and conventional septoplasty in patients with symptomatic deviated nasal septum |
| 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. Gaurang gaur |
| Designation |
Junior resident |
| Affiliation |
Dr. Rajendra Prasad govt. medical college , Tanda |
| Address |
Department of ENT OPD number 8 room number 201 Dr. Rajendra Prasad government medical college , Kangra at Tanda , Himachal Pradesh - 176001
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9119134409 |
| Fax |
|
| Email |
gauranggaur2312@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Munish saroch |
| Designation |
Head of department |
| Affiliation |
Dr. Rajendra Prasad government medical college , Tanda |
| Address |
Department of ENT Dr. Rajendra prasad government medical college, Kangra at Tanda , Himachal Pradesh - 176001
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418037099 |
| Fax |
|
| Email |
drsaroch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gaurang gaur |
| Designation |
Junior resident |
| Affiliation |
Dr. Rajendra Prasad government medical college, Tanda |
| Address |
Department of ENT OPD number 8 room number 201 Dr. Rajendra prasad government medical college, Kangra at Tanda , Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9119134409 |
| Fax |
|
| Email |
gauranggaur2312@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Rajendra Prasad government medical college, kangra at tanda , Himachal Pradesh , 176001 , India |
|
|
Primary Sponsor
|
| Name |
DR Rajendra Prasad government Medical College |
| Address |
Doctor rajendra prasad government medical College , kangra at tanda , Himachal Pradesh 176001, India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Rajendra Prasad government medical college |
Kangra at Tanda Himachal Pradesh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gaurang gaur |
Dr Rajendra prasad government medical college |
Department of Ent opd number 8 room number 201.
Kangra
HIMACHAL PRADESH |
9119134409
gauranggaur2312@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Rajendra prasad government medical college, Kangra at Tanda, Himachal Pradesh, India – 176 001 Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J342||Deviated nasal septum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional septoplasty |
Conventional septoplasty is a surgical procedure to correct a deviated nasal septum. Key points include:
1. Purpose: Primarily done to improve nasal airflow, relieve nasal obstruction, and treat symptoms like difficulty breathing, recurrent sinusitis, or snoring.
2. Procedure: Performed through incisions inside the nose to reposition or remove parts of the septum.
3. Invasive: More tissue dissection compared to endoscopic methods, which may result in increased postoperative discomfort and swelling.
4. Recovery: Longer recovery period with possible swelling, bruising, and nasal packing for a few days post-surgery.
5. Indications: Suitable for patients with moderate to severe septal deviation or those needing extensive correction.
6. Outcomes: Generally effective at improving nasal function and breathing, but with a higher risk of complications compared to endoscopic septoplasty. |
| Intervention |
Endoscopic septoplasty |
Endoscopic septoplasty is a minimally invasive surgical procedure used to correct a deviated nasal septum, improving airflow and reducing symptoms like nasal obstruction. Here are the key points:
1. Purpose: Corrects nasal blockage, improves breathing, and treats symptoms like snoring or sinusitis.
2. Minimally Invasive: Uses an endoscope for better visualization, requiring smaller incisions and causing less trauma.
3. Recovery: Shorter recovery time, less postoperative pain, and lower risk of complications compared to traditional septoplasty.
4. Indications: Recommended for patients with deviated septum, chronic sinusitis, or nasal polyps affecting breathing.
5. Outcomes: High success rates with improved nasal airflow and reduction in nasal symptoms.
It is a safer, more precise alternative to traditional septoplasty. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient aged 18-65 years.
2.Patient having symptomatic DNS.
3.Patients giving informed consent. |
|
| ExclusionCriteria |
| Details |
1.Patient having active URTI.
2.Patient below 18 years and above 65 years of age.
3.Pregnant and lactating females.
4.Patients having bleeding disorders.
5.Patient having allergic rhinitis
6.Patient having nasal polyps
7.Patients with history of previous nasal surgeries |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the outcome of conventional septoplasty and endoscopic septoplasty in patients aged 18 to 65 years with symptomatic deviated nasal septum. |
Baseline , one week and four weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to study the comparison between endoscopic septoplasty and conventional septoplasty in patients with symptomatic dns |
1 year |
|
|
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)
|
18/10/2024 |
| 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="0"
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
|
thesis, titled “Comparative Study between Endoscopic Septoplasty and Conventional Septoplasty in Patients of Symptomatic DNS,†aims to compare the effectiveness and outcomes of two surgical techniques used to treat deviated nasal septum (DNS), a common cause of nasal obstruction and related symptoms.
Key points of your study include:
1. Focus on Nasal Obstruction: DNS is a significant cause of nasal obstruction and is linked to conditions such as epistaxis, sinusitis, obstructive sleep apnea, and headaches. 2. Surgical Goals: An ideal surgical approach should relieve obstruction, be minimally invasive, avoid iatrogenic deformities, preserve the osteomeatal complex, and allow for revision surgery if necessary. 3. Comparison of Techniques: • Conventional Septoplasty: Often faces limitations like poor visualization, difficulty accessing pathology, and higher risks of unnecessary tissue manipulation. • Endoscopic Septoplasty: Offers advantages like better illumination, enhanced magnification, precise diagnosis, and the ability to address coexisting conditions like nasal polyps and septal spurs. 4. Anatomical Understanding: A thorough knowledge of nasal anatomy, including the septum and nasal valve, is critical for successful surgery. 5. Outcomes of Interest: The study will compare outcomes in terms of effectiveness in relieving nasal obstruction, complication rates, need for revision surgeries, and overall patient satisfaction.
Your study seeks to determine which approach offers better results for patients with symptomatic DNS. |