Follow-up in Childhood Functional Constipation: A Randomized, Controlled Clinical Trial

Abstract

Objectives: Guidelines recommend close follow-up during the treatment of childhood functional constipation. Only sparse evidence exists on how follow-up is best implemented. Our aim was to evaluate whether follow-up by phone or self-management through Web-based information improved treatment outcomes.

Methods: In this randomized controlled trial, conducted in secondary care, 235 children, ages 2 to 16 years, who fulfilled the Rome III criteria of childhood constipation, were assigned to 1 of the 3 follow-up regimens: control group (no scheduled contact), phone group (2 scheduled phone contacts), and Web group (access to Web-based information).

Primary outcome: number of successfully treated children after 3, 6, and 12 months.

Secondary outcomes: phone contacts, relapse, fecal incontinence, and laxative use.

Results: After 3 and 6 months, significantly more children in the Web group (79.7%/75.9%) were successfully treated compared with the control and phone groups (59.7%/63.6% and 63.3%/64.6%) (P = 0.007/P = 0.03). No difference was found after 12 months (control, 72.7%; phone, 68.4%; Web group, 78.5%; P = 0.40). Extra phone consultations were significantly more frequent in the Web group (44.3%) compared with the control group (28.6%) (P = 0.04). Before 3 months, 45.5% of phone consultations were completed in the Web group versus 28.8% and 25.8% in the control and phone groups (P = 0.05/P = 0.02). Relapses, fecal incontinence, and laxative use were not different between interventions.

Conclusions: Improved self-management behavior caused by access to self-motivated Web-based information induced faster short-term recovery during the treatment of functional constipation. Patient empowerment rather than health care-promoted follow-up may be a step toward more effective treatment for childhood constipation.

Trial registration: ClinicalTrials.gov NCT01582659.