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Silastic Stent Study

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ClinicalTrials.gov Identifier: NCT03282058
Recruitment Status : Active, not recruiting
First Posted : September 13, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Arif Janjua, University of British Columbia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pituitary Tumour Device: Silastic Stent Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned in one of two groups (stent vs no stent).
Masking: Single (Outcomes Assessor)
Masking Description: Histology of the healing tissues will be examined by a pathologist who is blinded to whether the patient received or did not receive stenting.
Primary Purpose: Supportive Care
Official Title: The Effect of Silastic Stenting on Post-Operative Intra-Nasal Re-Mucosalization
Actual Study Start Date : April 4, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Silastic Stent
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
The silastic stent is a splint made of silicone.

No Intervention: No Stent
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.



Primary Outcome Measures :
  1. 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. [ Time Frame: Total time approx. 4 months (pre-operative assessment; surgery; 4 and 12 weeks post-operative follow up appointments) ]
    Visual assessment of endoscopic photographs of healing tissue.

  2. 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. [ Time Frame: Total time approx. 4 months (pre-operative assessment; surgery; 4 and 12 weeks post-operative follow up appointments) ]
    Histologic assessment of healing tissues.

  3. Determining the effect of silastic stunting on nasa-septal flap donor sites on the patient's subjective nasal symptoms following endoscopic skull based surgery. [ Time Frame: Total time approx. 4 months (pre-operative assessment; surgery; 4 and 12 weeks post-operative follow up appointments) ]
    Participants will fill out a quality of life questionnaire called Sino-Nasal Outcome Test (SNOT-22).

  4. 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. [ Time Frame: Total time approx. 4 months (post-operative follow up at 4 and 12 weeks) ]
    Participants will fill out a post-operative rating scale.

  5. Physician's evaluation of the effect of silastic stunting on nasa-septal flap donor sites following endoscopic skull based surgery. [ Time Frame: Total time approx. 4 months (surgery; post-operative follow up at 4 and 12 weeks) ]
    Physician will fill out an outcome measures evaluation scale.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282058


Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Arif Janjua, MD University of British Columbia

Publications:
Karen A. Bednarski, Frederick A. Kuhn, Stents and Drug-Eluting Stents, Otolaryngologic Clinics of North America, Volume 42, Issue 5, October 2009, Pages 857-866, ISSN 0030-6665, http://dx.doi.org/10.1016/j.otc.2009.07.001.(http://www.sciencedirect.com/science/article/pii/S0030666509000930)
Cowin A, McIntosh D, Wormald PJ. Healing of wounds created in the nasal mucosa following endoscopic sinus surgery can be affected by different nasal packing materials. Primary Intention Vol. 10 No. 3 August 2002.
Ng M, Linthicum FH Jr. Long-term effects of Silastic sheeting in the middle ear. Laryngoscope. 1992 Oct;102(10):1097-102 Cote DWJ, Wright, ED. Objective outcome in endoscopic sinus surgery. In Advances in endoscopic sinus surgery. Prof. Cornel Lancu (Ed.) ISBN:978-953-307-7178
Soper, D.S. (2014). A-priori Sample Size Calculator for Student t-Tests [Software]. Available from http://www.danielsoper.com/statcalc

Responsible Party: Arif Janjua, MD, FRCSC, Otolarynology - Head & Neck Surgery; Endoscopic Sinus & Skull Based Surgery, University of British Columbia
ClinicalTrials.gov Identifier: NCT03282058     History of Changes
Other Study ID Numbers: H14-02101
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Arif Janjua, University of British Columbia:
Silastic Stenting
Trans-nasal Endoscopic Surgery
Post-operative Intra-nasal Re-mucosalization

Additional relevant MeSH terms:
Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hypothalamic Diseases
Pituitary Diseases
Endocrine System Diseases