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Morbidity of parotidectomy for benign parotid tumors with and without drain: The first interim analysis of prospective international randomized multicenter 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 complications such as bleeding, wound healing disorder, and sialocele. We present the results of the first interim analysis.
Methods From 05 to 11/2019, 60 subjects without blood aggregation disorder or permanent anticoagulation were scheduled for parotidectomy for benign lesion of 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, hematoma, wound healing disorder, presence of sialocele and facial nerve palsy during the hospitalization period and up to 4 weeks postoperatively.
Results From 60 subjects, 34 were assigned to the Redon- and 26 to the Non-Redon group. 10 subjects were excluded because of ECD in 2 cases, an inner lobe tumor in 6 and because of malignoma in 2 cases. Postoperative bleeding did not occur in any group. Seven subjects (11 %) presented with a hematoma without a need for revision surgery (2 in the Redon vs. 5 in the Non-Redon group). 32 subjects completed the entire follow-up. From them, 3 presented a wound healing disorder and 3 a sialocele. One patient still showed a facial nerve weakness (HB score 2). Incidence of postoperative bleeding and all other postoperative complications did not differ significantly in both groups (all p>0.05).
Conclusion In the first interim analysis, the absence of the wound drain was not associated with a higher risk of post-operative bleeding. In addition, Redon and non-Redon groups showed the same incidence of postoperative complications.
10 June 2020 (online)
© Georg Thieme Verlag KG
Stuttgart · New York