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Nasal Packing After Pituitary Surgery
N/A
Waitlist Available
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
Must not have
patients who do not have a working understanding of English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, 1 year.
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to determine if using nasal packing after pituitary tumor surgery through the nose is necessary. The study focuses on patients who have this specific type of surgery. Nasal packing is supposed to help control bleeding and support healing, but it may cause discomfort and increase healthcare costs without clear benefits.
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.
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.
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 belowSelect...
I am having my first surgery through the nose to remove a pituitary tumor.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have a good understanding of English.
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.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Anterior Skull Basal Nasal Inventory-12 (ASK-12)
Incidence of sinonasal adverse events
Secondary study objectives
Change in Analgesic and Antibiotic Usage
Change in EuroQual-5Dimension (EQ-5D)
Cost Analysis
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
No nasal packing.
2019
N/A
~60
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for pituitary tumors include surgical resection, radiation therapy, and medical therapy. Surgical resection, often performed via an endoscopic endonasal approach, aims to physically remove the tumor, which can alleviate symptoms caused by mass effect and hormonal imbalances.
Radiation therapy, including techniques like intensity-modulated radiation therapy (IMRT), targets and destroys tumor cells while sparing surrounding healthy tissue. Medical therapies, such as dopamine agonists or somatostatin analogs, work by inhibiting hormone secretion or shrinking the tumor.
These treatments are crucial for managing pituitary tumors as they address both the physical presence of the tumor and its hormonal effects. In the context of nasal packing, which is used post-surgery to control bleeding and support healing, understanding these treatments helps in managing postoperative care and improving patient outcomes.
Find a Location
Who is running the clinical trial?
The Ottawa Hospital Academic Medical AssociationOTHER
23 Previous Clinical Trials
2,896 Total Patients Enrolled
Ottawa Hospital Research InstituteLead Sponsor
577 Previous Clinical Trials
3,139,888 Total Patients Enrolled
The Physicians' Services Incorporated FoundationOTHER
163 Previous Clinical Trials
28,334 Total Patients Enrolled
Shaun Kilty, MDPrincipal InvestigatorThe Ottawa Hospital
2 Previous Clinical Trials
160 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a good understanding of English.I am having my first surgery through the nose to remove a pituitary tumor.I am 18 years old or older.You are allergic to Merocel nasal packing.
Research Study Groups:
This trial has the following groups:- Group 1: No Nasal Packing
- Group 2: Nasal Packing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.