Comparative Analysis of Silastic Stenting in Sinus Surgery

NCT06502197 | Not Yet Recruiting DMC

• 1 other identifier: H23-03592
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Silastic stenting is a measure taken to support tissue healing following sinus surgery. Silastic stents are inserted into the sinus cavities and provide structural support while facilitating healing in the critical period of recovery following surgery. There is controversy over the optimal duration for which silastic stents should be left in place. Having them in place for shorter periods may reduce the likelihood of stent-related reactions, while leaving them for longer periods could promote more tissue healing. The aim of this study is to compare the impact of stent duration on clinical outcomes of patients following sinus surgery.

Conditions

Chronic Rhinosinusitis (Diagnosis)

Keywords

Chronic Rhinosinusitis, Endoscopic Sinus Surgery, Silastic Stenting

Outcome Measures

Primary Outcomes (2)

• Long-Term Patency

  Patency is to be assessed by using the validated scoring system from Lund VJ, Kennedy DW. Quantification for staging sinusitis. In: Kennedy DW, editor. International Conference on Sinus Disease: Terminology, Staging, Therapy. Ann Otol Rhinol Laryngol 1995; 104(Suppl 167):17-21.

  6 and 18 months

• Incidence of acute sinus infection

  The occurrence and frequency of acute sinusitis in both cohorts, requiring rescue course of oral antibiotics.

  2 and 4 weeks

Secondary Outcomes (2)

• Tolerability Assessment

  At the respective stent extraction time

• Symptom Relief Assessment

  6 and 18 months post-op

Study Arms (2)

Short-term (4 weeks) Silastic Stenting

EXPERIMENTAL

Procedure: Silastic Stenting

Long-term (12 weeks) Silastic Stenting

EXPERIMENTAL

Procedure: Silastic Stenting

Interventions

Silastic Stenting PROCEDURE

Drill-out frontal sinus procedures, are a well-established surgical intervention in the management of CRS, involves extensive sinus surgery with the creation of a large, surgically exposed area of raw bone. This raw bone, left exposed postoperatively, poses a unique challenge in the context of mucosal healing. Silastic stents, inserted into the sinus cavities, offer a promising solution by providing structural support and facilitating mucosal re-mucolisation in this critical period of postoperative recovery.

Long-term (12 weeks) Silastic Stenting; Short-term (4 weeks) Silastic Stenting

Eligibility Criteria

• Age: 19 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with chronic rhinosinusitis requiring Frontal drill-out.

You may not qualify if:

• Patients unwilling or unable to comply with the study protocol.
• Previous Radiotherapy to operated area.

Sponsors & Collaborators

• University of British Columbia: lead
• Addenbrooke's Hospital, Cambridge University: collaborator
• NHS Greater Glasgow and Clyde: collaborator

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 16, 2024
• Study Start: September 2, 2024
• Primary Completion: September 2, 2025
• Study Completion: March 2, 2026
• Last Updated: July 16, 2024

Record last verified: 2024-07