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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Determining the effect of silastic stunting on gross level healing of the naso-septal flap donor sites in two aspects gross level healing and microscopic level of healing.
Timeframe: Total time approx. 4 months (pre-operative assessment; surgery; 4 and 12 weeks post-operative follow up appointments)
Determining the effect of silastic stunting on microscopic level healing of the naso-septal flap donor sites in two aspects gross level healing and microscopic level of healing.
Timeframe: Total time approx. 4 months (pre-operative assessment; surgery; 4 and 12 weeks post-operative follow up appointments)
Determining the effect of silastic stunting on nasa-septal flap donor sites on the patient's subjective nasal symptoms following endoscopic skull based surgery.
Timeframe: Total time approx. 4 months (pre-operative assessment; surgery; 4 and 12 weeks post-operative follow up appointments)
Determining the effect of silastic stunting on nasa-septal flap donor sites on the patient's subjective post-operative outcomes following endoscopic skull based surgery.
Timeframe: Total time approx. 4 months (post-operative follow up at 4 and 12 weeks)
Physician's evaluation of the effect of silastic stunting on nasa-septal flap donor sites following endoscopic skull based surgery.
Timeframe: Total time approx. 4 months (surgery; post-operative follow up at 4 and 12 weeks)