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Nasal Packing After Pituitary Surgery

N/A

Recruiting

Led By Shaun Kilty, MD

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

undergoing endoscopic endonasal transsphenoidal approach to pituitary resection for pituitary tumors of any pathology for the first time

18 years of age or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, 1 year.

Awards & highlights

Study Summary

This trial is testing whether nasal packing is necessary after surgery to remove pituitary tumors. The surgeon will randomly assign patients to either have nasal packing or not have packing, and then compare the outcomes between the two groups. The study will address whether it is feasible to enroll patients and get institutional approval for the trial.

Who is the study for?

This trial is for adults over 18 who are having their first endoscopic surgery to remove pituitary tumors. Participants must understand English and not be allergic to Merocel nasal packing.Check my eligibility

What is being tested?

The study aims to determine if using nasal packing after pituitary tumor surgery is necessary. Patients will either receive nasal packing or no packing at all, with the goal of assessing patient comfort and healthcare costs.See study design

What are the potential side effects?

While the side effects are not detailed in this summary, it's common that nasal packing can cause discomfort requiring pain medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having my first surgery through the nose to remove a pituitary tumor.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Anterior Skull Basal Nasal Inventory-12 (ASK-12)

Incidence of sinonasal adverse events

Secondary outcome measures

Change in Analgesic and Antibiotic Usage

Change in EuroQual-5Dimension (EQ-5D)

Cost Analysis

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: No Nasal PackingExperimental Treatment1 Intervention

No nasal packing will be placed during or after the surgery.

Group II: Nasal PackingActive Control1 Intervention

Nasal packing will be placed at the end of surgery.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor

561 Previous Clinical Trials

2,785,631 Total Patients Enrolled

The Physicians' Services Incorporated FoundationOTHER

162 Previous Clinical Trials

26,695 Total Patients Enrolled

Shaun Kilty, MDPrincipal InvestigatorThe Ottawa Hospital

2 Previous Clinical Trials

160 Total Patients Enrolled

Media Library

Nasal Packing Clinical Trial Eligibility Overview. Trial Name: NCT03677713 — N/A

Pituitary Tumors Research Study Groups: No Nasal Packing, Nasal Packing

Pituitary Tumors Clinical Trial 2023: Nasal Packing Highlights & Side Effects. Trial Name: NCT03677713 — N/A

Nasal Packing 2023 Treatment Timeline for Medical Study. Trial Name: NCT03677713 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has recruitment for this experiment been opened up?

"Affirmative. Clinicaltrials.gov attest that this medical experiment, which was first advertised on January 20th 2019, is currently recruiting patients. The study seeks 60 participants from a single medical centre."

Answered by AI

What purpose does this clinical research endeavor to fulfill?

"This clinical trial is designed to quantify the incidence of sinonasal adverse events at Post Op Day 0, 1, 2, 3 and Post-Op weeks 2 and 4. Along with this primary outcome measure, Change in Analgesic and Antibiotic Usage (total dosage administered during study period), Cost Analysis (direct/indirect costs associated with hospitalization & medication) and Post operative Pain (measured via VAS from 0 - 10) will also be assessed as secondary objectives."

Answered by AI

What is the sample size for this experiment?

"Affirmative. According to the clinicaltrials.gov webpage, this medical experiment is currently recruiting participants and was posted on January 20th 2019. The most recent update of the study occurred on April 19th 2022 with a goal of enrolling 60 patients at one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nasal Packing Following Endoscopic Endonasal Pituitary Resection

2019. "Nasal Packing Following Endoscopic Endonasal Pituitary Resection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03677713.

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