Clinical trial NCT06920368: Different Techniques for Prevention of Complications After Septoplasty Operation
Official title: Comparative Study Between the Efficacy of Trans-Septal Quilting Sutures, Nasal Pack and Intranasal Silicon Splint in Endoscopic Septoplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Septoplasty
Keywords: complication
quilting
splint
pack
septoplasty
endoscopic
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 90
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: complication of septoplasty
timeFrame: 1 week, one month and 3 months postoperatively
measure: post operative pain
timeFrame: 1 week, 1 month and 3 months postoperatively
measure: improvement of nasal symptoms
timeFrame: 1 week, 1 months and 3 months post operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
Study officials:
affiliation: Tanta University Hospitals
name: Emad Mohamed Shehata, Professor
role: PRINCIPAL_INVESTIGATOR
References: