Comparison of warm sitz bath and electronic bidet with a lower-force water flow for postoperative management after hemorrhoidectomy (BIDLOW)
摘要
Electronic bidets can be a substitute for sitz baths, but no study has examined the use of electronic bidets to manage anal problems.
MethodsA randomized, controlled, single-blind, multicenter, parallel group trial was performed. Patients who underwent hemorrhoidectomy were randomly assigned (1:1) to use the electronic bidet or warm sitz baths for 7 days after hemorrhoidectomy. The primary endpoint was the difference in the anal pain VAS score for 7 days posthemorrhoidectomy.
ResultsPatients were assigned to the electronic bidet (51) or sitz bath (50) groups. Twenty-six patients dropped out after randomization, and the final analysis included 34 patients in the electronic bidet group and 41 in the sitz bath group. The VAS score for anal pain 7 days posthemorrhoidectomy did not differ between the electronic bidet and sitz bath groups (38.3 ± 21.9 vs. 42.0 ± 21.1, p = 0.453). The upper limit of the 95% confidence interval of the VAS score in the electronic bidet group (81.22) was greater than the margin of noninferiority (46.20).
ConclusionThe VAS scores after hemorrhoidectomy did not differ between the electronic bidet and sitz bath groups, but the noninferiority of the electronic bidet to sitz baths for anal pain 7 days posthemorrhoidectomy was not verified.
Trial RegistrationThe trial was registered on ClinicalTrials.gov (Registration number: NCT02353156, date: 02/02/2015).