Nasal Splint and Endoscopic Nasal Septal Repair Surgery

NCT03575689 | Completed

• 1 other identifier: H15-03025
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

Septoplasty is one of the most performed surgeries in rhinology as a solo procedure, or in combination with sinus surgery. The procedure for septoplasty and postoperative management has evolved over time based on several studies that have been done. The current standard of care in our centre is to conduct a septoplasty using quilting technique and apply Doyle splints in both nostrils to stabilize the septum for 6 days. However these splints are associated with morbidity in the post-op period. The quilting technique was developed to prevent complications and stabilize the septum. This study examines the efficacy of these splints in stabilizing the septum and preventing complications after septoplasty

Conditions

Septum Deviated

Keywords

Nasal Splint; Septum deviation; Septoplasty

Outcome Measures

Primary Outcomes (1)

• Mladina

  Mladina Classification of Septal Deformity: This test will be performed by same blinded assessor before and after the surgery. This is a validated and widely used system for classifying nasal septal deviation.

  3 months for every patient

Secondary Outcomes (2)

• Visual Analog Scale

  3 months for every patient

• Postoperative complications

  3 months for every patient

Study Arms (2)

Splint

EXPERIMENTAL

A. The Doyle splint will be places in both nostrils of the patient after septoplasty. The doyle splints will be removed 6 days after surgery as per standard of care. No other procedures will be changed during the surgery.

Device: Doyle Splint

No Splint

NO INTERVENTION

B. No Doyle splints will be placed in the nostrils of the patient after septoplasty. All standart of care visits will remain the same.

Interventions

Doyle Splint DEVICE

Using Doyle splints following septoplasty is the standard of care and may help with stability of the septum in the immediate post op period. owever these splints are associated with morbidity in the post-op period. The quilting technique was developed to prevent complications and stabilize the septum. This study examines the efficacy of these splints in stabilizing the septum and preventing complications after septoplasty

Splint

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 19 years and above diagnosed with deviated nasal septum using the Mladina septal deviation scale who are complaining of nasal obstruction and/or sinus disease
• These patients will also be undergoing a nasal septoplasty either as a standalone case or as part of endoscopic sinus surgery and/or resection of the inferior turbinates. These surgeries could either be a primary or revision case.

You may not qualify if:

• Patients with sinonasal tumors
• Cystic fibrosis or syndromic patients (e.g. Wegeners granulomatosis, immunocompromised)
• Patients with autoimmune diseases
• Patients who do not understand English language and to understand the purpose, methods and conduct of this study.

Sponsors & Collaborators

• St. Paul's Hospital, Canada: lead

Study Sites (2)

E.N.T. Clinic, St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

St Paul Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Study Officials

• Amin Javer, MD FRCSCFARS

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The PI will be the blinded assessor. The choice of which patient gets a Doyle splint will be randomized using the sealed envelope system mentioned above. The randomization will be balanced to ensure that both arms have patients with extensive surgeries as well as isolated NSRs
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, St. Paul's Sinus Centre

Model Details: There will be two possible scenarios resulting from randomization: All patients will undergo septoplasty using quilting technique. A. The Doyle splint will be places in both nostrils of the patient after septoplasty. The doyle splints will be removed 6 days after surgery as per standard of care. No other procedures will be changed during the surgery. B. No Doyle splints will be placed in the nostrils of the patient after septoplasty. All standart of care visits will remain the same.

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: July 2, 2018
• Study Start: March 24, 2016
• Primary Completion: April 1, 2019
• Study Completion: May 1, 2019
• Last Updated: September 19, 2019

Record last verified: 2019-09

Locations

CA (2)