HemorrhoidPhase 2NCT02353156
Posthemorrhoidectomy Pain Management With Electronic Bidet or Sitz Bath
A Phase 2 study testing Electronic bidet and Sitz bath in people with Hemorrhoid, run by Seoul National University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hemorrhoid
- What is being tested?
- Electronic bidet and Sitz bath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 14 Sep 2016to 31 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the patients who undergo hemorrhoidectomy
Who cannot join
- previous history of anal surgery
- Crohn's anal disease
- perianal complex abscess or fistula
- uncontrollable medical disease
- Tb
- HIV
Show all 11Show fewer
- malignancy
- immunocompromised
- pregnancy
- breast feeding
- NSAID allergy
About this study
Official title: 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
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.
Read the detailed description
After hemorrhoidectomy, the patients should take warm sitz bath for relieving pain and inducing wound healing. Electronic bidet is a device for cleansing the anus after defecation, and some patients are using the bidet for sitz bath. Thus, the investigator perform this study for comparing the effect of pain and wound management after hemorrhoidectomy between sitz bath and electronic bidet
- Conditions
- Hemorrhoid
- Being tested
- Electronic bidet, Sitz bath
- Keywords
- Hemorrhoidectomy, postoperative pain, Sitz bath, Electronic bidet
- Medical subject headings
- Hemorrhoids, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic bidetOther
electronic bidet after hemorrhoidectomy for relieving pain and inducing wound healing
Sitz bathOther
sitz bath after hemorrhoidectomy for relieving pain and inducing wound healing
| Study group | Role | What they receive |
|---|---|---|
| Electronic bidet | Experimental | Electronic bidet for 3min at early morning for 4 weeks after hemorrhoidectomy Receives: Other: Electronic bidet |
| Sitz bath | Active comparator | Wamr sitz bath for 3min at early morning for 4 weeks after hemorrhoidectomy Receives: Other: Sitz bath |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
visual analog scale after hemorrhoidectomy at 1 week
Measured: 1 week
Secondary outcomes (3)
wound healing
wound healing rate at 4 week
Measured: 4 week
convenience
questionnaire survey for convenience of wound management after hemorrhoidectomy
Measured: 4 week
urinary difficulty
IPSS, urinary difficulty questionnaire
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study start14 Sep 2016
- Primary completion28 Mar 2018
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Daehang Hospital, Coway Co
- Responsible party
- Principal investigator, Kyu Joo Park, Seoul National University Hospital
- Investigators
- Kyu Joo Park, MD, PhD, Principal investigator, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353156
- Sponsor's protocol ID
- 2014-3144
- Status last verified
- Nov 2020
- First submitted
- 28 Jan 2015
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21218033Kwon 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.
PubMed 39757160
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02353156
- Acronym / sponsor ID
- 2014-3144
- Conditions
- Hemorrhoid
- Keywords
- Hemorrhoidectomy, postoperative pain, Sitz bath, Electronic bidet
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Daehang Hospital, Coway Co
- Study start
- 14 Sep 2016 (actual)
- Primary completion
- 28 Mar 2018 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 2 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After hemorrhoidectomy, the patients should take warm sitz bath for relieving pain and inducing wound healing. Electronic bidet is a device for cleansing the anus after defecation, and some patients are using the bidet for sitz bath. Thus, the investigator perform this study for comparing the effect of pain and wound management after hemorrhoidectomy between sitz bath and electronic bidet
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic bidet | Experimental | Other: Electronic bidetElectronic bidet for 3min at early morning for 4 weeks after hemorrhoidectomy |
| Sitz bath | Active comparator | Other: Sitz bathWamr sitz bath for 3min at early morning for 4 weeks after hemorrhoidectomy |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- the patients who undergo hemorrhoidectomy
Key exclusion criteria (11 listed)
- previous history of anal surgery
- Crohn's anal disease
- perianal complex abscess or fistula
- uncontrollable medical disease
- Tb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic bidetelectronic bidet after hemorrhoidectomy for relieving pain and inducing wound healing | Other | Electronic bidet |
| Sitz bathsitz bath after hemorrhoidectomy for relieving pain and inducing wound healing | Other | Sitz bath |
Primary outcome
pain score
Time frame: 1 week
visual analog scale after hemorrhoidectomy at 1 week
3 secondary outcomes
wound healing
Time frame: 4 week
convenience
Time frame: 4 week
urinary difficulty
Time frame: 4 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Background: PubMed 21218033Ryoo 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.
- Derived from this study: PubMed 39757160Kwon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyu Joo Park, MD, PhD principal investigator
Seoul National University College of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Electronic bidet and Sitz bath in people with Hemorrhoid, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02353156, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.