Different Techniques for Prevention of Complications After Septoplasty Operation

NCT06920368 | Recruiting DMC

• 1 other identifier: 9234837
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

the aim of the study is to compare complication of trans-nasal quilting sutures, nasal pack and intra intranasal silicon splint in endoscopic septoplasty

Conditions

Septoplasty

Keywords

complication; quilting; splint; pack; septoplasty; endoscopic

Outcome Measures

Primary Outcomes (3)

• complication of septoplasty

  endoscopic assessment of post operative recovery and complication

  1 week, one month and 3 months postoperatively

• post operative pain

  post operative pain will be assessed via Visual Analogue scale ( VAS ) on scale from 0 to 10 as higher scores mean worse outcome.

  1 week, 1 month and 3 months postoperatively

• improvement of nasal symptoms

  improvement of nasal symptoms will be assessed by using validated Arabic version of NOSE score from 0 to 4 as higher scores mean worse outcome.

  1 week, 1 months and 3 months post operatively

Study Arms (3)

nasal pack

ACTIVE COMPARATOR

pack is put after septoplasty operation for prevention of complication of septoplasty

Procedure: septoplasty with nasal packs

intra-nasal silicon splint

ACTIVE COMPARATOR

intra-nasal silicon splint is put after septoplasty operation for prevention of complication of septoplasty

Procedure: septoplasty with intra-nasal silicon splint

trans-septal quilting sutures

ACTIVE COMPARATOR

trans-septal quilting sutures after septoplasty operation for prevention of complication of septoplasty

Procedure: septoplasty with trans--septal quilting sutures

Interventions

septoplasty with nasal packs PROCEDURE

Septoplasty to all the patients will be done using general hypotensive anesthesia via cuffed oral endotracheal tube. The patient will be positioned in a slight reverse Trendelenburg position. Local hemostasis will be achieved by injection of lidocaine with epinephrine (1:100000) with placement of topical epinephrine soaked cotton (1:1000) then nasal packs in inserted at the end of operation for prevention of post operative complication

nasal pack

septoplasty with intra-nasal silicon splint PROCEDURE

Septoplasty to all the patients will be done using general hypotensive anesthesia via cuffed oral endotracheal tube. The patient will be positioned in a slight reverse Trendelenburg position. Local hemostasis will be achieved by injection of lidocaine with epinephrine (1:100000) with placement of topical epinephrine soaked cotton (1:1000) then intra-nasal silicon splint is inserted at the end of operation for prevention of post operative complication

intra-nasal silicon splint

septoplasty with trans--septal quilting sutures PROCEDURE

Septoplasty to all the patients will be done using general hypotensive anesthesia via cuffed oral endotracheal tube. The patient will be positioned in a slight reverse Trendelenburg position. Local hemostasis will be achieved by injection of lidocaine with epinephrine (1:100000) with placement of topical epinephrine soaked cotton (1:1000) then trans-septal quilting sutures is done at the end of operation for prevention of post operative complication

trans-septal quilting sutures

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy adult patient of different ages from 16 to 60 year-old with symptomatic deviated nasal septum

You may not qualify if:

• Patient with nasal polyposis or nasal tumors or patients with sinusitis not responding to medical treatment.
• Patient with previous septal operation
• Patient who is planned to do partial inferior turbinectomy or turbinoplasty with septoplasty
• Patients with contraindications for general surgery

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Egypt

RECRUITING

Study Officials

• Emad Mohamed Shehata, Professor

  Tanta University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Yahia Ata, Master

CONTACT

0201018454445; ahmed179467_pg@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal invistigator

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 9, 2025
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

EG (1)