跳至主要内容
临床试验/NCT03282058
NCT03282058Unknown不适用

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

University of British Columbia0 个研究点目标入组 26 人开始时间: 2016年4月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
26
主要终点
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.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Histology of the healing tissues will be examined by a pathologist who is blinded to whether the patient received or did not receive stenting.

入排标准

性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

Silastic Stent

Experimental

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.

干预措施: Silastic Stent (Device)

No Stent

No Intervention

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.

结局指标

主要结局

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.

时间窗: 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.

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.

时间窗: Total time approx. 4 months (post-operative follow up at 4 and 12 weeks)

Participants will fill out a post-operative rating scale.

Physician's evaluation of the effect of silastic stunting on nasa-septal flap donor sites following endoscopic skull based surgery.

时间窗: Total time approx. 4 months (surgery; post-operative follow up at 4 and 12 weeks)

Physician will fill out an outcome measures evaluation scale.

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.

时间窗: Total time approx. 4 months (pre-operative assessment; surgery; 4 and 12 weeks post-operative follow up appointments)

Histologic assessment of healing tissues.

Determining the effect of silastic stunting on nasa-septal flap donor sites on the patient's subjective nasal symptoms following endoscopic skull based surgery.

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arif Janjua

MD, FRCSC, Otolarynology - Head & Neck Surgery; Endoscopic Sinus & Skull Based Surgery

University of British Columbia

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