Different Techniques for Prevention of Complications After Septoplasty Operation

Not Applicable

Recruiting

• Conditions: Septoplasty

• Registration Number: NCT06920368
• Lead Sponsor: Tanta University

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

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 Timeline

• Study Start: 2024-05-01
• Study First Submitted: 2025-03-20
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-07
• Study First Posted: 2025-04-09
• Last Update Submitted: 2025-04-13
• Last Update Posted: 2025-04-16
• Primary Completion: 2025-05
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
post operative pain	1 week, 1 month and 3 months postoperatively	post operative pain will be assessed via Visual Analogue scale ( VAS ) on scale from 0 to 10 as higher scores mean worse outcome.
complication of septoplasty	1 week, one month and 3 months postoperatively	endoscopic assessment of post operative recovery and complication
improvement of nasal symptoms	1 week, 1 months and 3 months post operatively	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.

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, Egypt