Different Techniques for Prevention of Complications After Septoplasty Operation

Comparative Study Between the Efficacy of Trans-Septal Quilting Sutures, Nasal Pack and Intranasal Silicon Splint in Endoscopic Septoplasty

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

Study Overview

• Status: Recruiting
• Conditions: Septoplasty
• Intervention / Treatment: Procedure: septoplasty with nasal packs; Procedure: septoplasty with intra-nasal silicon splint; Procedure: septoplasty with trans--septal quilting sutures

Detailed Description

Septoplasty is the recommended procedure for treating deviated septum and many surgeons are adopting an increasingly conservative approach to septal surgery, such that only the deviated portion of the septum is addressed by the surgery.

The surgical methods utilized in this procedure differ, though the procedure typically involves removal of the deviated cartilage and bony septum that creates a dead space between the mucosal flaps. Although rare, complications such as septal hematoma and consequently abscess formation, adhesions and perforation can occur post-operatively. Three main methods have been employed to prevent such complications. These are intranasal occlusive packing, intranasal silicon splinting, and trans-septal quilting suturing.

However, the totally occlusive nasal packing has many temporary negative effects on the patients' quality of life, which are well studied in the literature. The main disadvantages include: sleep disturbance, patient's discomfort, local pain, headache, dysphagia, breathing difficulty, anxiety and more severe pain on pack removal(6). Bilateral nasal packing may affect the respiratory function due to inadequate oral breathing causing nocturnal hypoxia, which may become more apparent in patients with obstructive sleep apnea or chronic lung diseases. Eustachian tube dysfunction, intranasal infections, toxic shock syndrome, laryngeal or bronchial spasm, myocardial infarction, cerebrovascular accidents has been reported. In addition, the mucosal damage caused by nasal packing may lead to loss of cilia and affects the mucociliary clearance during the healing period.

Intranasal silicone splinting is fast, technically simple and can be used for cartilage support. However, it can cause discomfort in terms of frequent sneezing and epiphora and has a potential risk for bacterial colonization.

The most important advantages of the suture technique include: the non-obliteration of the nasal cavities and the absence of agony associated with pack removal, so it highly decreases patient's discomfort and anxiety related to breathing and pack removal.

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

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Yahia Ata, Master; Phone Number: 0201018454445; Email: ahmed179467_pg@med.tanta.edu.eg

Study Locations

• Egypt
  • Tanta, Egypt
    • Recruiting
    • Tanta University Hospitals
    • Contact: Ahmed Yahia Ata, Master; Phone Number: 0201018454445

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: nasal pack; pack is put after septoplasty operation for prevention of complication of septoplasty	Procedure: septoplasty with nasal packs; 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
Active Comparator: intra-nasal silicon splint; intra-nasal silicon splint is put after septoplasty operation for prevention of complication of septoplasty	Procedure: septoplasty with intra-nasal silicon splint; 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
Active Comparator: trans-septal quilting sutures; trans-septal quilting sutures after septoplasty operation for prevention of complication of septoplasty	Procedure: septoplasty with trans--septal quilting sutures; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Emad Mohamed Shehata, Professor, Tanta University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 13, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: endoscopic; septoplasty; complication; splint; quilting; pack
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Trace Elements; Micronutrients; Silicon
• Other Study ID Numbers: 9234837

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No