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Nasal Packing Following Endoscopic Endonasal Pituitary Resection

NCT03677713 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-12-13

No results posted yet for this study

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

Interventions

PROCEDURE

No nasal packing.

No nasal packing at the end of the surgery

PROCEDURE

Nasal Packing

Patients will have nasal packing at the end of the surgery

Sponsors & Collaborators

  • The Physicians' Services Incorporated Foundation

    collaborator OTHER

  • The Ottawa Hospital Academic Medical Association

    collaborator OTHER

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Shaun Kilty, MD · The Ottawa Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-20
Primary Completion
2024-04-24
Completion
2024-04-24

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03677713 on ClinicalTrials.gov