NCT02353156

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2016

Typical duration for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 2, 2015

Completed
1.6 years until next milestone

Study Start

First participant enrolled

September 14, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2018

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

1.5 years

First QC Date

January 28, 2015

Last Update Submit

November 10, 2020

Conditions

Keywords

Hemorrhoidectomypostoperative painSitz bathElectronic bidet

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

EXPERIMENTAL

Electronic bidet for 3min at early morning for 4 weeks after hemorrhoidectomy

Other: Electronic bidet

Sitz bath

ACTIVE COMPARATOR

Wamr sitz bath for 3min at early morning for 4 weeks after hemorrhoidectomy

Other: Sitz bath

Interventions

electronic bidet after hemorrhoidectomy for relieving pain and inducing wound healing

Electronic bidet

sitz bath after hemorrhoidectomy for relieving pain and inducing wound healing

Sitz bath

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

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: 21218033BACKGROUND
  • Kwon 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.

MeSH Terms

Conditions

HemorrhoidsPain, Postoperative

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Kyu Joo Park, MD, PhD

    Seoul National University College of Medicine

    PRINCIPAL INVESTIGATOR

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