Titre officiel
Nasal Packing Following Endoscopic Endonasal Pituitary Resection
Sommaire:
Chez les chirurgiens de la base du crâne et
de rhinologie, il y a une controverse importante au sujet de l’utilisation du
tamponnement nasal à la suite d’une résection de tumeurs hypophysaires par voie
endoscopique endonasale à titre de traitement nécessaire. La justification de l’utilisation
systématique du tamponnement nasal après une chirurgie hypophysaire n’est pas
claire, car cette pratique n’est pas utilisée pour une chirurgie des sinus d’importante
équivalente. Il n’existe pas d’autres données scientifiques probantes à l’appui
de cette pratique, et un récent sondage mené auprès de chirurgiens canadiens
qui pratiquent cette chirurgie révèle une division claire dans la pratique en
ce qui concerne l’utilisation systématique du tamponnement nasal. Chez les
patients, le tamponnement nasal entraîne un inconfort important nécessitant une
médication, et son utilisation augmente les coûts directs et involontaires de l’hospitalisation
et du système de santé pour chaque cas. Les avantages, les inconvénients et les
coûts associés au tamponnement nasal à la suite d’une résection hypophysaire
transsphénoïdale par voie endoscopique endonasale n’ont pas été étudiés.
OBJECTIF : Déterminer si le tamponnement nasal à la suite d’une chirurgie
de tumeur hypophysaire par voie endoscopique endonasale est un traitement
nécessaire. Les principales questions de recherche de cette étude, notre projet
pilote interne de l’ECRA, portent sur la faisabilité du recrutement de patients
subissant une chirurgie de tumeur hypophysaire transsphénoïdale par voie
endoscopique endonasale en utilisant le protocole complet de l’ECRA relatif au
tamponnement nasal comparativement à l’absence de tamponnement nasal. Le projet
pilote portera sur la faisabilité de l’inscription propre au site et de l’approbation
éthique de l’établissement et de l’administration du protocole.
Description de l'essai
Primary Outcome:
- Anterior Skull Basal Nasal Inventory-12 (ASK-12)
- Incidence of sinonasal adverse events
Secondary Outcome:
- Change in EuroQual-5Dimension (EQ-5D)
- Cost Analysis
- Change in Analgesic and Antibiotic Usage
- Post operative pain
BACKGROUND AND CLINICAL SIGNIFICANCE
Over the past decade, the surgical method for removing pituitary tumours 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 tumours, 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 tumour 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 tumour 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 tumour 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 tumour resection.
HYPOTHESIS
Nasal packing following routine endoscopic pituitary tumour 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.
Voir cet essai sur ClinicalTrials.gov
