Intrarectal Electromotive Botulinum Toxin Type A Administration in Children With Intractable Constipation: A Randomized Clinical Trial

Abstract

INTRODUCTION: Children with refractory constipation might not respond to conventional medical treatments. In this study, we assessed the effectiveness of intrarectal botulinum toxin type A/electromotive drug administration (BoNTA/EMDA) on constipation in these children and compared its efficacy with routine intrasphincteric BoNTA injection. METHODS: From 2017 to 2019, 60 children aged 5–13 years who fulfilled Rome III criteria for intractable constipation were enrolled and randomly assigned into 2 treatment groups. EMDA group (n = 30) underwent BoNTA/EMDA, whereas the control group (n = 30) received injection of BoNTA into the internal anal sphincter. A complete bowel habit diary (with data on the frequency of defecation per week, stool form, and the number of fecal soiling episodes), a constipation score questionnaire, and a visual pain score were recorded before treatment and at 1 month and 6 months after treatment. In addition, children in both groups were assessed with a constipation-related quality of life questionnaire. RESULTS: After 1-month follow-up, treatment reduced the number of patients fulfilling the diagnostic criteria in both EMDA (24/30, 80%) and injection (25/30, 83.3%) groups (P < 0.001). The stool form was normalized in 73.3% (22/30) in EMDA group and 80% (24/30) in injection group after treatment. The median of constipation score and pain score decreased significantly in both groups after treatment (P < 0.001 and P < 0.001, respectively). DISCUSSION: BoNTA/EMDA seems to be as effective as intrasphincteric BoNTA injection for treatment of intractable constipation. In addition, this technique is associated with less comorbidity, is less costly, and can be performed in an office-based setting without general anesthesia.

How do we define therapy-resistant constipation in children aged 4–18 years old? A systematic review with meta-narrative synthesis

“…1 Yik et al , 18 Bellomo-Brandao et al , 21 Arruda et al , 59 Noviello et al , 60 Mousavi et al . 47 2 Hynes et al , 53 Rawat et al , 48 RBR-7mry33, Kajbafzadeh et al , 43 Ng et al , 42 Gupta et al , 39 Puoti et al , 25 Monjaraz et al , 52 Kuizenga-Wessel et al , 40 Koppen et al , 51 Wessel et al , 44 Campos et al , 24 Nurko et al , 10 RBR-344jq8, Redkar et al , 19 Redkar et al . 36 3 Bonilla et al , 16 Heitmann et al , 23 Gomez-Suarez et al , 37 van Wunnik et al , 35 Haddad et al , 46 Gonzalez et al .…”

“…6 Menakaya et al , 55 Zacur et al , 31 Carr et al , 30 Koppen et al , 17 van der Wilt et al , 27 Bellomo-Brandao et al , 50 Valitutti et al . 29 *At least 2 years: Yik et al , 18 Hynes et al ; 53 at least 12 months: Bellomo-Brandao et al , 21 Arruda et al , 59 Rawat et al , 48 RBR-7mry33; at least 6 months: Kajbafzad et al ; 43 at least 3 months: Noviello et al , 60 Gupta et al , 39 Puoti et al , 25 Monjaraz et al , 52 Kuizenga-Wessel et al , 40 Koppen et al , 17 Wessel et al , 44 Mousavi et al , 47 Campos et al , 24 Nurko et al , 10 RBR-344jq8; at least 1 month: Redkar et al , 19 Redkar et al . 36 …”

“…One study implemented the Rome IV criteria without specifying a duration, 22 four studies employed the Rome III/IV criteria with a specific duration. 34 35 38 61 Three studies employed Rome III criteria 42 43 59 and one study used Rome IV criteria 49 with specific duration. Among the studies that established a duration, some considered a period of 6 months or longer, 42 43 one study used a period of 12 months 59 while others required the fulfilment of the Rome III/IV criteria for a minimum of 3 months of treatment.…”