Comparative Study - Transseptal Suture Technique Verses Anterior Nasal Packing After Septoplasty
Trans Septal Suture Technique Verses Anterior Nasal Packing After Septoplasty - A Comparative Study
The goal of this clinical trial is to see the outcomes of the two techniques used after septoplasty in terms of postoperative nasal pain and nasal bleeding in the patients with deviated nasal septum of 18 to 50 years of age presented in a tertiary care hospital. The main questions it aims to answer are:
- any significant difference between the two techniques in terms of post operative nasal pain?
- any significant difference between the two techniques in terms of post operative nasal bleeding? Researchers will be comparing the outcomes of these two techniques while participants already admitted in ward will be examined on 1st postoperative day.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Ghazal Iftakhar
- Phone Number: +92 3309869344
- Email: ghazaliftakhar@gmail.com
Study Locations
-
-
Fedral
-
Islamabad, Fedral, Pakistan, 44080
- Recruiting
- Pakistan Institute of Medical Sciences (PIMS), Islamabad.
-
Contact:
- Personal Assistant
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- symptomatic deviated nasal septum
- 18-50 years of age
- both male and female genders
Exclusion Criteria:
- history of previous nasal surgery
- presence of chronic rhinosinusitis with or without nasal polyposis
- pregnant females
- immunocompromised patients
- patients with pulmonary and/or cardiovascular disorders
- patients those who received steroidal or anticoagulant therapy within last 30 days.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Group A = with anterior nasal packing postoperative septoplasty
Group A will consists of 30 participants which will have anterior nasal packing done postoperatively, after septoplasty.
|
ANP
|
|
Active Comparator: Group B = with trans-septal suture technique
Group B will have 30 participants which will have trans-septal suture technique performed in septoplasty.
|
Trans-septal suture technique in septoplasty
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post operative Nasal Pain
Time Frame: 24 hours after surgery on first post operative day
|
This will be assessed using Visual Analog scale on first post operative day
|
24 hours after surgery on first post operative day
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post operative nasal hemorrhage
Time Frame: 24 hours after surgery on first post operative day
|
This will be assessed on first post operative day
|
24 hours after surgery on first post operative day
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Study Chair: Dr. Altaf Hussain, Pakisrtan Institute of Medical Sciences, Islamabad.
Publications and helpful links
General Publications
- Wang D, Liu T, Liao C, Tang G, Tian T, Tian L. Is nasal septal suturing an alternative technique to nasal packing?: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2020 Dec 11;99(50):e23535. doi: 10.1097/MD.0000000000023535.
- Ivanova PP, Iliev G. Nasal Packing in Septal Surgery: A Narrative Review. Cureus. 2023 Mar 21;15(3):e36488. doi: 10.7759/cureus.36488. eCollection 2023 Mar.
- Alsaggaf ZH, Almadfaa AO, Marouf AA, Alfawaz KS, Niyazi RA, Ibrahim NK, Ajlan AM. Sinusitis and its association with deviated nasal septum at a tertiary hospital: A retrospective study. J Taibah Univ Med Sci. 2022 Jun 18;17(6):1065-1069. doi: 10.1016/j.jtumed.2022.06.001. eCollection 2022 Dec.
- Alghamdi FS, Albogami D, Alsurayhi AS, Alshibely AY, Alkaabi TH, Alqurashi LM, Alahdal AA, Saber AA, Almansouri OS. Nasal Septal Deviation: A Comprehensive Narrative Review. Cureus. 2022 Nov 10;14(11):e31317. doi: 10.7759/cureus.31317. eCollection 2022 Nov.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- No.F.1-1/2015/ERB/SZABMU/1428
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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