Nasal Packing Following Endoscopic Endonasal Pituitary Resection

NCT03677713 | Completed

• 1 other identifier: 20180541-01H
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Tumor

Keywords

endoscopic; endonasal; transsphenoidal; surgical resection; pituitary tumour; nasal packing; Merocel

Outcome Measures

Primary Outcomes (2)

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

  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

  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 Outcomes (4)

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

  Post Op Day 0, 1, 2, 3 and Post-Op weeks 2 and 4

• Cost Analysis

  Through study completion, 1 year.

• Change in Analgesic and Antibiotic Usage

  Post Op Day 0, 1, 2, 3 and Post-Op weeks 2 and 4

• Post operative pain

  Post Op Day 0, 1, 2, 3 and Post-Op weeks 2 and 4

Study Arms (2)

Nasal Packing

ACTIVE COMPARATOR

Nasal packing will be placed at the end of surgery.

Procedure: Nasal Packing

No Nasal Packing

EXPERIMENTAL

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

Procedure: No nasal packing.

Interventions

No nasal packing. PROCEDURE

No nasal packing at the end of the surgery

No Nasal Packing

Nasal Packing PROCEDURE

Patients will have nasal packing at the end of the surgery

Nasal Packing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• The Physicians' Services Incorporated Foundation: collaborator
• The Ottawa Hospital Academic Medical Association: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Shaun Kilty, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FRCSC

Model Details: A single center, non-blinded, randomized controlled trial (RCT) will be conducted as a pilot study.

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: September 19, 2018
• Study Start: January 20, 2019
• Primary Completion: April 24, 2024
• Study Completion: April 24, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)