Silastic Stent Study

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Silastic Stenting on Post-Operative Intra-Nasal Re-Mucosalization

Conditions
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Pituitary Tumour

Intervention / Treatment
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* Device: Silastic Stent


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned in one of two groups (stent vs no stent).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silastic Stent<br>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. | Device: Silastic Stent<br>* The silastic stent is a splint made of silicone.<br>|
| No Intervention: No Stent<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Visual assessment of endoscopic photographs of healing tissue. | 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. | Histologic assessment of healing tissues. | 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. | Participants will fill out a quality of life questionnaire called Sino-Nasal Outcome Test (SNOT-22). | 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. | Participants will fill out a post-operative rating scale. | 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. | Physician will fill out an outcome measures evaluation scale. | Total time approx. 4 months (surgery; post-operative follow up at 4 and 12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Silastic Stenting, Trans-nasal Endoscopic Surgery, Post-operative Intra-nasal Re-mucosalization