Surgery versus botulinum neurotoxin A to reduce drooling and improve daily life for children with neurodevelopmental disabilities: a randomized controlled trial.

AIM: To compare the effect of bilateral submandibular duct ligation and botulinum neurotoxin A (BoNT-A) on drooling severity and its impact on daily life and care in children and adolescents with moderate-to-severe drooling. METHOD: This was a randomized, interventional, controlled trial in which 53 children and adolescents (31 males, 22 females, mean age 11y, range 8-22y, SD 2y 10mo) with cerebral palsy (58.5%) or other non-progressive developmental disorders (41.5%) were randomized to BoNT-A (n=26) or bilateral submandibular duct ligation (n=27). A parent questionnaire on the severity of drooling in specific positions and daily activities and the impact of drooling on daily life and care was filled out at baseline and 8 and 32 weeks posttreatment. RESULTS: Both BoNT-A and bilateral submandibular duct ligation had a positive effect on daily care, damage to electronic equipment and/or furniture, social interactions, and self-esteem. However, bilateral submandibular duct ligation had a significant greater and longer-lasting short- (8wks) and medium-term (32wks) effect on daily care, reducing damage to electronic devices, and improving social interactions and satisfaction with life in general. INTERPRETATION: This randomized controlled trial confirms reduced drooling by both BoNT-A and bilateral submandibular duct ligation, but provides new evidence on improved well-being through a reduction in drooling. Even though there is a greater risk of complications and morbidity after bilateral submandibular duct ligation, compared to BoNT-A there was a significantly greater and longer-lasting positive effect on most outcomes. What this paper adds Bilateral botulinum neurotoxin A (BoNT-A) and submandibular duct ligation had a positive effect on the well-being of individuals with moderate-to-severe drooling. Bilateral submandibular duct ligation had a greater effect on the impact of drooling during daily care than BoNT-A. Bilateral submandibular duct ligation reduced damage to electronic devices and improved social interactions and satisfaction with life.

An evaluation of predictors for success of two-duct ligation for drooling in neurodisabilities.

BACKGROUND: Drooling is dependent on various clinical variables. However, while drooling proves refractory to two-duct ligation in 40% of patients, predictors for treatment success are sparse and to date there is little evidence why some respond well while others are non-responders. We aim to find predictors for treatment success and study the effectiveness of two-duct ligation for drooling in neurodisabilities. METHODS: Fifty-four patients with moderate to severe drooling who had undergone two-duct ligation were screened for inclusion. Four patients were excluded due to missing or unreliable primary outcomes. The average age at the time of surgery was 12 years. Predictors were evaluated for treatment success which was defined as ≥ 50% visual analog scale for severity of drooling and/or drooling quotient reduction from baseline. Treatment effect was measured after 8 and 32 weeks compared to baseline. RESULTS: Age (more mature), adequate posture (no anteflexion), and normal speech are predictors for treatment success. Compared to baseline, drooling quotient was significantly lower at 8 (difference 18.6%, 95% confidence interval 12.3-24.9%) and 32 weeks (difference 10.1%, 95% confidence interval 3.9-16.4%). Compared to baseline, visual analog scale was significantly lower at 8 (difference 45.0, 95% confidence interval 37.0-52.9) and 32 weeks (difference 32.9, 95% confidence interval 25.0-40.7). CONCLUSIONS: Age, adequate posture, and a normal speech are predictors for treatment success, are easily determined pre-operatively, and help the clinician providing patient-specific probability of treatment success. There is a significant subjective and objective decrease of drooling after two-duct ligation.

Unsuccessful submandibular duct surgery for anterior drooling: Surgical failure or parotid gland salivation?

OBJECTIVES: To evaluate if drooling recurrence after surgery of the submandibular ducts is due to surgical failure or other variables. METHODS: Historic cohort with prospective collected data of all patients with severe drooling who underwent unsuccessful submandibular duct surgery with subsequent re-intervention between 2003 and 2018. A reference cohort was used for comparison of clinical variables. RESULTS: Six males and 4 females were included (cerebral palsy n = 8, neurodevelopmental disorders n = 2). All patients underwent submandibular gland surgery as a primary intervention (duct ligation n = 8, submandibular duct relocation n = 2) followed by re-intervention (submandibular gland excision n = 7, parotid duct ligation n = 3). One patient underwent tertiary surgery (parotid duct ligation after re-intervention by submandibular gland excision). Three patients were successful after re-intervention. No difference was found between both re-intervention techniques. There was significantly more severe dental malocclusion (50% vs. 21%, P value = 0.047) and severe speech disorders (80% vs. 42%, P value = 0.042) in the current cohort when compared to the reference cohort. CONCLUSION: Recurrence of drooling surgery is most likely not caused by surgical failure of the primary intervention, because re-intervention (submandibular gland excision) did not lead to more success. Dysarthria and dental malocclusion might negatively influence treatment outcome.

Randomized controlled trial comparing botulinum vs surgery for drooling in neurodisabilities.

OBJECTIVE: To compare the effect of submandibular duct ligation (2-DL) and submandibular botulinum neurotoxin type A (BoNT-A) for drooling in children and adolescents with neurodevelopmental disabilities. METHODS: A randomized, interventional, controlled, and partly single-blinded study was performed in which submandibular BoNT-A was compared with 2-DL to treat excessive drooling. Main outcomes included a Visual Analog Scale (VAS), drooling quotient (DQ), drooling severity (DS) scale and drooling frequency (DF) scale. Each was obtained at baseline, and 8 and 32 weeks post treatment. RESULTS: Fifty-seven patients (mean age: 11 years, mean baseline VAS score 7.9, mean baseline DQ 27.3%) were randomized to the 2-DL or BoNT-A group. Four patients were excluded from analyses, leaving 53 patients for intention-to-treat analyses. Response to treatment, defined as a ≥50% reduction in DQ or VAS score, was higher for 2-DL after 32 weeks (63.0% vs 26.9%, p = 0.008). Both VAS score (24.5, p < 0.001) and DQ (-9.3%, p = 0.022) were significantly lower at follow-up after 2-DL vs BoNT-A. The total number of adverse events (p = 0.088, 40.7% vs 19.2%) and postoperative complaints was higher (p < 0.001, mean 9.6 vs 3.6 days) for 2-DL than for BoNT-A. CONCLUSION: The 2-DL procedure is a more effective treatment for drooling than botulinum toxin, but carries a slightly greater risk of complications and morbidity. TRIALREGISTERNL IDENTIFIER: NTR3537. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that for children and adolescents with neurodevelopmental disabilities and severe drooling, 2-DL compared to a one-time intraglandular BoNT-A injection is more effective at reducing drooling at 32 weeks.

Bilateral transcervical submandibular gland excision for drooling: A study of the mature scar and long-term effects.

AIM: Several surgical techniques are available to treat drooling in neurologically disabled children and adolescents, with bilateral submandibular gland excision being the only transcervical procedure. External scars can be a reason to decline for this surgical approach. We investigated which factors influenced caregiver satisfaction by evaluating the long-term scar in relation to treatment outcome. METHODS: We identified a historical cohort, in which all neurologically disabled patients who underwent bilateral submandibular gland excision for drooling between January 2009 and December 2013 were identified (n = 41). The Patient and Observer Scar Assessment Scale (POSAS) was used to evaluate observer and clinician satisfaction. All included patients were contacted by telephone and completed a digital questionnaire that included digital images of the scars. RESULTS: Of the caregivers that responded the questionnaire 76% (19/25) were satisfied with the overall outcome. Twenty-four (96%) caregivers considered the scars acceptable. Caregiver satisfaction was not correlated to the appearance of scars, but was significantly correlated with the decrease in drooling severity on a visual analogue scale (p = 0.035) and decrease in lower respiratory tract infections (p = 0.042). INTERPRETATION: The appearance of scars does not influence satisfaction after bilateral submandibular gland excision for drooling. As expected, satisfaction is correlated to the treatment outcome.

[Cranial nerve palsy caused by tumours of the head and neck]. / Hersenzenuwuitval door hoofd-halstumoren.

Cranial nerve palsy is a diagnostic guiding symptom, but often goes unrecognized. The differential diagnosis includes a variety of diseases, including malignant tumours of the head and neck. Here we describe three cases of cranial nerve palsy. In two of the cases the palsy was recognized following physical examination; this altered the differential diagnosis and work-up plan. In the third case the patient initially presented with cranial nerve palsy, and this case indicates the importance of the addition of diagnostic imaging. When a patient presents with cranial nerve pathology, physical examination has to be performed, searching for an underlying cause. And vice versa: if a patient presents with vague symptoms or a lump in the head and neck area, examination of the cranial nerves should be kept in mind. If oncology is suspected, the patient should be referred to an otolaryngologist at a head and neck oncology centre.