Nasal Packing Following Endoscopic Endonasal Pituitary Resection

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

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