Silastic Stent Study

University of British Columbia

Status: Unknown

Conditions: Pituitary Tumour

Treatments: Device: Silastic Stent

Study type: Interventional

Funder types: Other

Identifiers

NCT03282058

H14-02101

Details and patient eligibility

About

Endoscopic skull base surgery is a relatively new procedure that is now a standard of care for surgeries at the base of the skull; however there are no studies that examine the healing process of the nasal lining with the use of silastic (silicone) stents (or splints) that might be placed at the time of surgery. While there is some evidence to suggest that the use of stents improves wound healing, the decision to use a stent or not is currently up to the preference of the surgeon. To investigate the impact of stents on post-surgical healing, the investigators at Vancouver General Hospital will compare patients undergoing trans-sphenoidal pituitary surgeries with septal flap reconstruction with the use of silastic stents to line the septal donor site, and compare their recovery to those who did not receive stents. The investigators hypothesize that the use of silastic stents in endonasal surgery increases the rate of mucosal healing, and better quality mucosal regeneration, and with no effect on the patients experience after surgery. In this randomized control trial the investigators aim to recruit 26 (13 in each arm) study participants. The primary outcome is to determine the effect of silastic stunting on healing of the naso-septal flap donor site. This objective will be achieved by assessment of endoscopic photographs of healing tissue and histologic assessment of healing tissues. The secondary outcome involves questionnaires that measure the patient's subjective nasal symptoms prior to and following endoscopic skull based surgery. Total time commitment for the study participant is about 4 months across 4 study visits (all of which are part of standard of care): the assessment visit, surgery, 4 weeks post-operative follow up visit and 12 week post-operative follow up visit.

Enrollment: 26 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients undergoing trans-sphenoidal endoscopic pituitary surgery at their first post-operative appointment

Exclusion criteria

• patients with inflammatory sinus conditions
• patients having undergone extensive skull base reconstructions
• patients having received previous radiotherapy

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Silastic Stent

Experimental group

Description:

At the time of surgery, if the patient is identified in the "silastic stent" arm, dressing of the septal donor site with silastic stents will be performed after reconstruction has been achieved and the surgeon feels that the surgery proceeded routinely.

Treatment:

Device: Silastic Stent

No Stent

No Intervention group

Description:

At the time of surgery, if the patient is identified in the "no silastic stent" arm, dressing of the septal donor site without the stent will be performed after reconstruction has been achieved and the surgeon feels that the surgery proceeded routinely - this is currently the standard of care.