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DOI: 10.1055/s-0042-1747065
Morbidity of parotidectomy for benign parotid tumors with and without drain: An interim analysis of prospective international randomized multicenter trial: The REDON trial
Introduction The aim of this prospective randomized multicenter international trial was to analyze the effect of a drain placement on the incidence of postoperative bleeding after parotidectomy for benign lesions. We present the results of the interim analysis.
Methods From 05/2019 to 11/2021, 341 subjects without blood clotting disorder or permanent anticoagulation were scheduled for parotidectomy for benign lesion in the superficial parotid gland. Before wound closure, the patients were randomized into the Redon- or Non-Redon groups. The drain in the Redon group patients was removed on the 2nd postoperative day. We analyzed complications as postoperative bleeding (primary outcome), hematoma, wound healing disorder, presence of sialocele and facial nerve palsy during the hospitalization period and up to 4 weeks postoperatively.
Results 174 subjects were assigned to the Redon and 167 to the Non-Redon group. 46 subjects were excluded because of a change in operation technique or of a diagnosis. Postoperative bleeding which requered revision surgery occurred in 3 cases (1%; 1 in the Redon-, 2 in the Non-Redon group, p>.05). Hematoma was present in 46 subjects (15.6%; 8 in Redon-, 38 in the Non-Redon groups, p< .001). Of 260 subjects who completed the entire follow-up of four weeks, a sialocele occurred in 20 subjects (8.4%) (Redon vs. Non-Redon, p >.05). Besides, 24 subjects (10%) showed facalis weakness, significantly more often in the Redon group (n=18), compared to the Non-Redon group (6), p<.05.
Conclusion The interim analysis did not show a higher risk of postoperative bleeding without any redon drain placement.
Jean-Uhrmacher-Stiftung, Deutschen Studienzentrum für HNO-Heilkunde, Kopf- und Hals-Chirurgie (DSZ-HNO), Deutsche Gesellschaft für Hals, -Nasen- und Ohrenheilkunde Kopf-und Halschirurgie e.V.
Publikationsverlauf
Artikel online veröffentlicht:
24. Mai 2022
© 2022. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).
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