Posthemorrhoidectomy Pain Management With Electronic Bidet or Sitz Bath
Single Blind, Randomized Controlled, Multicenter Study to Evaluate the Efficacy and Convenience of Electronic Bidet With Very Low Force Flow Fountain System for Pain Control and Wound Healing After Operation for Anal Disease, Compared to Conventional Sitz Bath
1 other identifier
interventional
76
0 countries
N/A
Brief Summary
The investigator will perform a randomized clinical trials to compare the effect of pain management and wound healing after hemorrhoidectomy between warm sitz bath and electronic bidet.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2016
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2015
CompletedFirst Posted
Study publicly available on registry
February 2, 2015
CompletedStudy Start
First participant enrolled
September 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedNovember 12, 2020
November 1, 2020
1.5 years
January 28, 2015
November 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pain score
visual analog scale after hemorrhoidectomy at 1 week
1 week
Secondary Outcomes (3)
wound healing
4 week
convenience
4 week
urinary difficulty
4 week
Study Arms (2)
Electronic bidet
EXPERIMENTALElectronic bidet for 3min at early morning for 4 weeks after hemorrhoidectomy
Sitz bath
ACTIVE COMPARATORWamr sitz bath for 3min at early morning for 4 weeks after hemorrhoidectomy
Interventions
electronic bidet after hemorrhoidectomy for relieving pain and inducing wound healing
sitz bath after hemorrhoidectomy for relieving pain and inducing wound healing
Eligibility Criteria
You may qualify if:
- the patients who undergo hemorrhoidectomy
You may not qualify if:
- previous history of anal surgery
- Crohn's anal disease
- perianal complex abscess or fistula
- uncontrollable medical disease
- HIV
- malignancy
- immunocompromised
- pregnancy
- breast feeding
- NSAID allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Daehang Hospitalcollaborator
- Coway Cocollaborator
Related Publications (2)
Ryoo S, Song YS, Seo MS, Oh HK, Choe EK, Park KJ. Effect of electronic toilet system (bidet) on anorectal pressure in normal healthy volunteers: influence of different types of water stream and temperature. J Korean Med Sci. 2011 Jan;26(1):71-7. doi: 10.3346/jkms.2011.26.1.71. Epub 2010 Dec 22.
PMID: 21218033BACKGROUNDKwon YH, Ryoo SB, Oh HK, Lee JB, Jung HJ, Song KH, Heo SC, Shin R, Lee J, Park KJ. Comparison of warm sitz bath and electronic bidet with a lower-force water flow for postoperative management after hemorrhoidectomy (BIDLOW). BMC Surg. 2025 Jan 6;25(1):5. doi: 10.1186/s12893-024-02737-0.
PMID: 39757160DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyu Joo Park, MD, PhD
Seoul National University College of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 28, 2015
First Posted
February 2, 2015
Study Start
September 14, 2016
Primary Completion
March 28, 2018
Study Completion
December 31, 2020
Last Updated
November 12, 2020
Record last verified: 2020-11