Comparison of Outcomes of Conventional Septoplasty vs Conservative Endoscopic Septoplasty

NCT07434765 | Completed DMC

• 1 other identifier: Sheikh Zayed Hospital Lahore
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

OBJECTIVE To compare the outcome of conventional septoplasty and conservative endoscopic septoplasty for symptomatic deviated nasal septum. DATA COLLECTION PROCEDURE This randomized control study will be conducted in the ENT department at Shaikh Zayed Hospital, Lahore, over six months. Ethical approval will be obtained and informed consent forms will be completed by all participants. A sample of 210 cases will be selected using a non-probability consecutive sampling technique, with patients randomized into two groups based on the lottery method: 105 will undergo conventional septoplasty (Group A), and 105 will undergo conservative endoscopic septoplasty (Group B). Detailed patient history and clinical examination will be recorded, and each case will be evaluated subjectively and objectively preoperatively. Nasal septal deviation will be classified based on the side (right, left, or S-shaped) and anatomical involvement (anterior, posterior, or both), with posterior rhinoscopy and diagnostic nasal endoscopy will be performed as needed to rule out other pathologies. For patients in the conventional septoplasty group, the traditional surgical technique for septoplasty will be applied in which bilateral flap elevation will be done. In the conservative endoscopic septoplasty group, an incision will be made 2 mm posterior to the caudal end of the septum (hemitransfixation) on the concave side to access the bony-cartilaginous junction abnormality. The initial mucoperichondrial flap will be elevated. Proper plane elevation will be performed to minimize bleeding, and exposure will be limited to the targeted area.

Conditions

Deviated Nasal Septum

Keywords

septoplasty

Outcome Measures

Primary Outcomes (3)

• Rate of Residual Septal Deviation

  Residual septal deviation is defined as the persistent deviation of the nasal septum from the midline, as observed after surgical intervention (e.g., septoplasty), and confirmed through endoscopic examination

  3 weeks

• Rate of Septal Perforation

  Septal perforation is defined as a full-thickness defect in the nasal septum-extending through the mucoperichondrium and/or mucoperiosteum and underlying cartilage or bone-creating an abnormal communication between the two nasal cavities. A visible hole or defect in the nasal septum confirmed by anterior rhinoscopy or nasal endoscopy

  1 week

• Rate of Synechiae

  Synechiae are defined as abnormal adhesions between the nasal septum and the lateral nasal wall or turbinates, resulting from healing after trauma, surgery, infection, or inflammation, and confirmed by clinical examination via nasal endoscopy

  3 weeks

Study Arms (2)

Conventional septoplasty

PLACEBO COMPARATOR

Procedure: conventional septoplasty

endoscopic septoplasty

EXPERIMENTAL

Procedure: endoscopic septoplasty

Interventions

conventional septoplasty PROCEDURE

For patients in the conventional septoplasty group, the traditional surgical technique for septoplasty will be applied in which bilateral flap elevation will be done. In the conservative endoscopic septoplasty group, an incision will be made 2 mm posterior to the caudal end of the septum (hemitransfixation) on the concave side to access the bony-cartilaginous junction abnormality. The initial mucoperichondrial flap will be elevated. Proper plane elevation will be performed to minimize bleeding, and exposure will be limited to the targeted area. For cases involving subluxated cartilage from the crest, excess cartilage will be carefully trimmed with a No.15 blade Bard-Parker knife without disrupting the vomerochondral junction. Cartilage near the anterior nasal spine will be repositioned over the crest to prevent supra-tip deformity. Any laterally projecting vomerine spur or overlapping cartilage will be resected. In instances of posterior deviation or ethmochondral junction deviation, t

Conventional septoplasty

endoscopic septoplasty PROCEDURE

In the conservative endoscopic septoplasty group, an incision will be made 2 mm posterior to the caudal end of the septum (hemitransfixation) on the concave side to access the bony-cartilaginous junction abnormality. The initial mucoperichondrial flap will be elevated. Proper plane elevation will be performed to minimize bleeding, and exposure will be limited to the targeted area. For cases involving subluxated cartilage from the crest, excess cartilage will be carefully trimmed with a No.15 blade Bard-Parker knife without disrupting the vomerochondral junction. Cartilage near the anterior nasal spine will be repositioned over the crest to prevent supra-tip deformity. Any laterally projecting vomerine spur or overlapping cartilage will be resected. In instances of posterior deviation or ethmochondral junction deviation, the bony septum will be fractured for midline alignment or minimally resected at the ethmoidal plate's caudal end. A 'C' shaped deviation will be corrected through prec

endoscopic septoplasty

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Individuals with symptomatic deviated nasal septum.
• Patients aged between 16 and 50.
• Patients who show willingness to surgery.

You may not qualify if:

• Individuals with allergic rhinitis, vasomotor rhinitis, acute infection, and other systemic illnesses.
• Individuals who have undergone other nasal procedure such as turbinectomy.

Sponsors & Collaborators

• Shahida Islam Medical Complex: lead

Study Sites (1)

Shaikh Zayed Hospital, Lahore

Lahore, Punjab Province, 60000, Pakistan

Location

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: Clinical Professor

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 27, 2026
• Study Start: November 18, 2025
• Primary Completion: January 17, 2026
• Study Completion: January 17, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

PA (1)