Nasal Packing Following Endoscopic Endonasal Pituitary Resection

March 21, 2023 updated by: Ottawa Hospital Research Institute

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Andrea L Lasso, M.Sc.
  • Phone Number: 10222 613-798-5555
  • Email: alasso@toh.ca

Study Contact Backup

  • Name: Corliss Best, MD
  • Phone Number: 72968 613-737-8899
  • Email: cbest@toh.ca

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post Op Day 0, 1, 2, 3 and Post-Op weeks 2 and 4
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
Post Op Day 0, 1, 2, 3 and Post-Op weeks 2 and 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Post Op Day 0, 1, 2, 3 and Post-Op weeks 2 and 4
Cost Analysis
Time Frame: Through study completion, 1 year.
An analysis of the direct and indirect costs related to hospitalization and medication use.
Through study completion, 1 year.
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 Op Day 0, 1, 2, 3 and Post-Op weeks 2 and 4
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.
Post Op Day 0, 1, 2, 3 and Post-Op weeks 2 and 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Collaborators

The Physicians' Services Incorporated Foundation

Investigators

  • Principal Investigator: Shaun Kilty, MD, The Ottawa Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2019

Primary Completion (Anticipated)

November 20, 2023

Study Completion (Anticipated)

April 30, 2024

Study Registration Dates

First Submitted

July 6, 2018

First Submitted That Met QC Criteria

September 17, 2018

First Posted (Actual)

September 19, 2018

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20180541-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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