Different Techniques for Prevention of Complications After Septoplasty Operation

NCT ID: NCT06920368

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-05-01

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

Conditions

Septoplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

nasal pack

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

Group Type: ACTIVE_COMPARATOR

septoplasty with nasal packs

Intervention Type: 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

intra-nasal silicon splint

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

Group Type: ACTIVE_COMPARATOR

septoplasty with intra-nasal silicon splint

Intervention Type: 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

trans-septal quilting sutures

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

Group Type: ACTIVE_COMPARATOR

septoplasty with trans--septal quilting sutures

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Yahia Ibrahim Ata

principal invistigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emad Mohamed Shehata, Professor

Role: PRINCIPAL_INVESTIGATOR

Tanta University Hospitals

Locations

Tanta University Hospitals

Tanta, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed Yahia Ata, Master

Role: CONTACT

ahmed179467_pg@med.tanta.edu.eg

0201018454445

Facility Contacts

Ahmed Yahia Ata, Master

Role: primary

0201018454445

Other Identifiers

9234837

Identifier Type: -

Identifier Source: org_study_id