Nasal Packing Following Endoscopic Endonasal Pituitary Resection

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ClinicalTrials.gov Identifier: NCT03677713

Recruitment Status : Recruiting

First Posted : September 19, 2018

Last Update Posted : April 20, 2022

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Sponsor:

Collaborator:

The Physicians' Services Incorporated Foundation

Information provided by (Responsible Party):

Ottawa Hospital Research Institute

Study Description

Brief Summary:

There is considerable controversy about the use of nasal packing following endoscopic endonasal resection of pituitary tumors as a necessary treatment amongst Rhinology-Skull Base Surgeons. The justification for the routine use of nasal packing following pituitary surgery is not clear as this practice is not used for equally extensive sinus surgery. Further scientific evidence supporting this practice is lacking, and a recent survey of Canadian surgeons performing this surgery demonstrates clear division in practice for the routine use of nasal packing. Nasal packing causes patients significant discomfort requiring medication, and the use of packing adds direct and unintended hospitalization and health system costs for every case for which it is used. The benefits, short-comings, and associated costs of nasal packing following endoscopic endonasal transsphenoidal pituitary resection have not been studied.

OBJECTIVE: To determine if nasal packing following endoscopic endonasal pituitary tumor surgery is a necessary treatment. The principal research questions for this study, our internal pilot of the RCT, pertain to feasibility of enrolment of patients undergoing endoscopic endonasal transsphenoidal pituitary tumor surgery using the full RCT protocol of nasal packing versus no nasal packing. The pilot will address feasibility of site-specific enrolment and feasibility of institutional ethics approval and protocol administration.

Condition or disease	Intervention/treatment	Phase
Pituitary Tumor	Procedure: No nasal packing. Procedure: Nasal Packing	Not Applicable

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Detailed Description:

BACKGROUND AND CLINICAL SIGNIFICANCE

Over the past decade, the surgical method for removing pituitary tumors has shifted from a microscopic resection technique performed exclusively by a neurosurgeon, to an endoscopic resection done as a team with an otolaryngologist and neurosurgeon. This field continues to evolve given this recent shift in treatment technique.

Nasal packing has historically been a post-operative intervention of treating the nose employed by otolaryngologists for any nasal surgery they performed. However, with the advent of endoscopic sinus surgery and changes in surgical technique, the use of nasal packing has become less common. A systematic review by Quinn et. Al (2013) showed that nasal packing caused more patient discomfort than any other post-septoplasty maneuver and did not prevent complications of septoplasty, but could contribute to adverse events following septoplasty. In North America, nasal packing is no longer commonly used after septoplasty.

However, following the endoscopic resection of pituitary tumors, the practice of nasal packing is still widely employed. The reasoning for placement of nasal packing following surgery is not clear, just as it was not for its use following septoplasty. A thorough search of the literature did not identify any publications providing justification for the use of nasal packing. Published recommendations to reduce incidence of post-operative nasal complications after transsphenoidal pituitary tumor resection include use of specific nasal medications (intranasal corticosteroids) and regular nasal saline irrigation (in patients without cerebrospinal fluid rhinorrhea) to clear nasal mucosal hyperemia edema and secretions, as well as to prevent nasal synechiae and scarring, to maintain the sinus cavity drainage, and accelerate the recovery of the physiological function of the paranasal sinus. However, an evidence based recommendation in support or against routine nasal packing has not been made. A review from neurosurgical literature on perioperative management post transsphenoidal pituitary resection reports the majority of patients do not require insertion of nasal packing at the time of surgery, some patients (intraoperative Cerebral spinal fluid (CSF) leaks requiring sellar floor reconstruction, Cushing's Disease, and acromegaly) may benefit from their insertion, and if used packing is typically removed postoperative day 1.

In January 2018 an informal email survey of Canadian Otolaryngologists who routinely perform endoscopic pituitary surgery with a neurosurgeon (total of 7 respondents out of 11 surgeons, 64% response rate) demonstrated that 5 of 7 use nasal packing following the procedure; 2 of 7 do not. Packing is usually left in place for 48 hours when used. A screening of institution websites (February 12, 2018) in North America where this surgery is routinely performed found a balanced number of institutions that list the use or non-use of nasal packing following endoscopic pituitary tumor resection (13 institutional websites screened, 8 institutions routinely use nasal packing, 5 do not). There is clinical equipoise related to the use of nasal packing. An objective study assessing the utility of nasal packing following endoscopic endonasal pituitary surgery has not yet been completed.

This study seeks to answer the question, "Is routine nasal packing following endoscopic pituitary tumor surgery a necessary treatment?". The results of this trial have the potential to standardize practice patterns in Canada and internationally, and will inform evidence based practice while directly impacting the quality of care delivered to patients undergoing pituitary tumor resection.

HYPOTHESIS

Nasal packing following routine endoscopic pituitary tumor surgery is an unnecessary intervention that may cause patients unjustified post-operative discomfort, negatively affect their quality of life, and unnecessarily increase associated cost of care.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	A single center, non-blinded, randomized controlled trial (RCT) will be conducted as a pilot study.
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Nasal Packing Following Endoscopic Endonasal Pituitary Resection
Actual Study Start Date :	January 20, 2019
Estimated Primary Completion Date :	November 20, 2022
Estimated Study Completion Date :	April 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Familial isolated pituitary adenoma

MedlinePlus related topics: Endoscopy Pituitary Disorders Pituitary Tumors

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Nasal Packing Nasal packing will be placed at the end of surgery.	Procedure: Nasal Packing Patients will have nasal packing at the end of the surgery
Experimental: No Nasal Packing No nasal packing will be placed during or after the surgery.	Procedure: No nasal packing. No nasal packing at the end of the surgery

Outcome Measures

Primary Outcome Measures :

Anterior Skull Basal Nasal Inventory-12 (ASK-12) [ Time Frame: Post Op Day 0, 1, 2, 3 and Post-Op weeks 2 and 4 ]
The ASK-12 is a validated patient reported nasal QOL questionnaire that evaluates morbidity after endonasal skull base surgery. Twelve symptoms related to nasal health are scored 0-5 and a global score is the mean value. Lower scores reflect better sinonasal quality of life.
Incidence of sinonasal adverse events [ Time Frame: Post Op Day 0, 1, 2, 3 and Post-Op weeks 2 and 4 ]
Evaluated by comparing the proportion of patients in each group who develop any sinonasal adverse events ( epistaxis, sinusitis, synechia, CSF rhinorrhea, nasal septal perforation

Secondary Outcome Measures :

Change in EuroQual-5Dimension (EQ-5D) [ Time Frame: Post Op Day 0, 1, 2, 3 and Post-Op weeks 2 and 4 ]
Quality of Life Survey
Cost Analysis [ Time Frame: Through study completion, 1 year. ]
An analysis of the direct and indirect costs related to hospitalization and medication use.
Change in Analgesic and Antibiotic Usage [ Time Frame: Post Op Day 0, 1, 2, 3 and Post-Op weeks 2 and 4 ]
The total amount (dosage) of analgesic and antibiotics administered during the study period.
Post operative pain [ Time Frame: Post Op Day 0, 1, 2, 3 and Post-Op weeks 2 and 4 ]
Will be captured using a visual analogue scale (VAS). Scores range from 0 to 10. Lower score indicate less severe pain.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years of age or older
undergoing endoscopic endonasal transsphenoidal approach to pituitary resection for pituitary tumors of any pathology for the first time

Exclusion Criteria:

patients who do not have a working understanding of English
patients with known allergy to Merocel nasal packing

Contacts and Locations

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): NCT03677713

Contacts

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Contact: Andrea L Lasso, M.Sc.	613-798-5555 ext 10222	alasso@toh.ca
Contact: Corliss Best, MD	613-737-8899 ext 72968	cbest@toh.ca

Locations

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Canada, Ontario
The Ottawa Hospital	Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Andrea Lasso, MSc 6137985555 ext 10222 alasso@toh.ca

Sponsors and Collaborators

Ottawa Hospital Research Institute

The Physicians' Services Incorporated Foundation

Investigators

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Principal Investigator:	Shaun Kilty, MD	The Ottawa Hospital

More Information

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Responsible Party:	Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:	NCT03677713
Other Study ID Numbers:	20180541-01H
First Posted:	September 19, 2018 Key Record Dates
Last Update Posted:	April 20, 2022
Last Verified:	April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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

Keywords provided by Ottawa Hospital Research Institute:


endoscopic endonasal transsphenoidal surgical resection	pituitary tumour nasal packing Merocel

Additional relevant MeSH terms:

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Pituitary Neoplasms Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases Endocrine Gland Neoplasms	Neoplasms by Site Neoplasms Hypothalamic Neoplasms Supratentorial Neoplasms Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms

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