Background In this prospective nonrandomized multicenter trial, we analyze the incidence of early and late complications after parotidectomy in correlation to the extent of dissection. Methods A total of 148 patients underwent a parotidectomy for a benign lesion in the superficial lobe. The number of intraoperatively dissected main facial nerve branches was photo‐documented and defined the extent of tissue dissection. Early postoperative complications including sialocele were evaluated until 4 weeks after surgery. Late complications as facial nerve palsy, Frey's syndrome (FS) and the outcome of the scar and substance loss were furthermore assessed after 6 and 12 months. Results Early complications occurred in 22 patients (14%) and did not depend on the extent of facial nerve dissection (all P > .05). However, patients with higher number of intraoperatively dissected facial nerve branches showed significantly higher palsy scores on the first postoperative day (P = .026). FS occurred with incidence of 69% and correlated significantly to the extent of dissection (P = .003). Appearance of the scar and substance loss improved significantly during the follow‐up (P < .001 and P < ,005, respectively) without significant correlation to the extent of dissection (P > .05 for both variables after 12 months). Conclusions Less extensive tissue dissection resulted in better postoperative facial nerve function on the first postoperative day and in lower incidence of FS after 12 months. However, incidence of early complications did not depend on the extent of surgery. The study was registered in the German Clinical Trials Register prior to conducting the research. DRKS‐ID: DRKS00008967, URL:http://apps.who.int/trialsearch/.

Objectives Treatment with botulinum toxin A (BoNT) is the therapy of choice for many patients with facial synkinesis. Repeated injections relieve hypertonicity and hyperkinesis of reinnervated mimic muscles. Aim of the study was to prove if the injection regime and dosage of BoNT change during long‐time therapy. Design Retrospective analysis of patients´ data, who were treated for synkinesis with BoNT from 1998 to 2018. Setting Tertiary referral facial nerve centre. Participants Injection pattern of BoNT was based on clinical symptoms, observations of the specialist and on previous treatment pattern. Onabotulinumtoxin (OnaBoNT), Incobotulinumtoxin (IncoBoNT) and Abobotulinumtoxin (AboBoNT) were available for treatment. Patients consulted our department for following treatment as soon as the symptoms re‐occurred. Main outcome measures Change in dosage and injection pattern, the time intervals between treatments over the entire therapy period. Results Seventy‐three patients were repeatedly injected. The median number of treatments was 18, the median treatment interval was 3.0 months. During the initial treatment, orbicularis oculi and the mentalis muscles were the most frequently injected muscles (94%). During repeated treatment, the number of injected muscles increased significantly (P < .0001), whereas the dose per muscle remained stable. The initial dose was 24 U (95%‐CI 22‐27 U) for OnaBoNT and IncoBoNT; 69 U for AboBoNT(95%‐CI 44‐94 U). We observed a significant increase in dosage for OnaBoNT and IncoBoNT (P < .0001) during the long‐term therapy. The time intervals between treatments were stable for all three BoNT preparations (P > .05). Conclusions We observed significant change in treatment dose and injection pattern of BoNT in patients with facial synkinesis. These results provide an orientation in dose finding and injection regimen of BoNT in the long‐term course of therapy.

Zusammenfassung Einleitung Zur Wertigkeit einer Wunddrainage bei einer Parotidektomie existieren keine validen klinischen Studien. Das Ziel der aktuellen Studie ist es zu untersuchen, ob durch die Einlage bzw. den Verzicht auf eine geschlossene Wunddrainage (sog. Redon) bei einer lateralen und partiellen Parotidektomie die Häufigkeit der postoperativen Komplikationen, wie Nachblutung, Wundheilungsstörung und Wundinfektion, sowie Speichelzyste und -fistel beeinflusst wird. Methoden Es wurde eine europaweite multizentrische, prospektive, randomisierte Studie geplant. Durch das Hauptprüfzentrum (HNO-Uniklinik Köln), in Kooperation mit den HNO-Universitätskliniken Jena und Göttingen, wurde das Studienprotokoll erstellt. Die Fallzahlberechnung wurde mit G*Power durchgeführt. Die Studie umfasst Probanden mit einer Indikation zu Parotidektomie bei einem gutartigen Tumor ohne bekannte Gerinnungsstörung oder weitergeführte Antikoagulation. Die präoperative Randomisierung und das Data Management erfolgen softwaregestützt (REDCap 9.1.24, Vanderbilt University). Ergebnisse Die Studie wurde 10/2019 durch die federführende Ethikkommission zustimmend bewertet und ist seit April 2019 offen. Zum aktuellen Zeitpunkt nehmen 9 HNO-Kliniken, davon 6 in Deutschland und 3 in Österreich, an der Studie teil. Hierbei werden in 7 Zentren aktiv Probanden eingeschlossen. Bei einer kalkulierten Follow-to-treat-Gruppengröße von 800 Probanden beträgt die geplante Laufzeit der Studie 4 Jahre. Schlussfolgerungen Die Redon-Studie ist die weltweit erste prospektive randomisierte Studie, die die Wertigkeit einer Drainageeinlage bei einer Parotidektomie untersucht. Um das Rekrutierungsziel in geplanter Zeit erreichen zu können, ist die Teilnahme weiterer spezialisierter Kliniken dringend notwendig. Wir möchten zudem alle HNO-Ärzte ermutigen, ihre Patienten auf die Redon-Studie aufmerksam zu machen, sie über die Möglichkeit zur Studienteilnahme aufzuklären und in eine der teilnehmenden Kliniken zu überweisen.

Background: The aim of our manuscript was to evaluate the time course of clinical and electromyographical (EMG) reinnervation after the reanimation of the smile using a gracilis muscle transplant which is reinnervated with the masseteric nerve. Methods: We present a case series of five patients with a longstanding peripheral facial palsy, who underwent a reanimation of the lower face using a gracilis muscle transplant with masseteric nerve reinnervation from June 2019 to October 2020. Trial-specific follow-up examinations were carried out every three months using clinical assessment and EMG, up to 12 months after the surgery. The grading was carried out using the House–Brackmann scale (HB), the Stennert Index, and a self-designed Likert-like scale for graft reinnervation and smile excursion. Results: The surgery was feasible in all of the patients. The reanimation was performed under general anesthesia in an inpatient setting. Postoperative complications which resulted in prolonged hospitalization occurred in two of the five patients. All of the patients showed a preoperative flaccid facial palsy. The first single reinnervation potentials were detected 3.1 ± 0.1 months after surgery. After 5.6 (±1.4) months, in three (3/5) patients, clear reinnervation patterns were present. Clinically, the patients obtained symmetry of the face at rest after 5.6 (±1.4) months, and could spontaneously smile without the co-activation of the jaw after an average time of 10.8 (±1.8) months. All of the patients were able to express a spontaneous emotion-stimulated smile after one year. Conclusion: Micro-neurovascular gracilis muscle transfer reinnervated with a masseteric nerve is a sufficient and reliable rehabilitation technique for the lower face, and is performed as a single-stage surgery. The nerve supply via the masseteric nerve allows the very rapid and strong reinnervation of the graft, and results in a spontaneous smile within 10 months.

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