The role of Botulinum Toxin for the Management of post Parotidectomy Sialocele: A Randomized Controlled Trial.

[BACKGROUND] Parotid fistula or Sialocele is a general consequence of a penetrating injury of parotid gland or parotidectomy surgery which may be caused serious complications. Studies show different approaches had various effects on management of sialocele complications after parotidectomy. The purpose of this study is to evaluate the effects of botulinum toxin (BTX) on total/ partial and partial superficial parotidectomy complications.

[METHODS] Patients with benign parotid gland tumors were included in this bicentric, double-blind, parallel, randomized clinical trial from 2021 to 2023. One hundred subjects underwent parotidectomy with/ without BTX injection were randomly assigned into two groups including the intervention (BTX group) ( = 50) and control group ( = 50) then the clinical information of all mentioned patients was assessed.

[RESULTS] Hematoma, infection, opening of the wound, warmth or swelling was not observed in either group. BTX group had significantly lower Postoperative drainage volume versus control group on both 24 and 48 h after surgery (23 vs. 19 mL,  < 0.02 at first day and 27 vs. 12,  = 0.003 at second day). Although the incidence of sialocele was lower in the BTX group than the control group (2/50 [4%] vs. 6/50 [12%]) with ( = 0.269) but it wasn't significant.

[CONCLUSION] The study results demonstrated that botulinum toxin may be safe and effective therefore BTX injection in improving parotidectomy complications like sialocele was recommended.