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Posthemorrhoidectomy Pain Management With Electronic Bidet or Sitz Bath

Primary Purpose

Hemorrhoid

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Electronic bidet

Sitz bath

About this trial

This is an interventional treatment trial for Hemorrhoid focused on measuring Hemorrhoidectomy, postoperative pain, Sitz bath, Electronic bidet

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

the patients who undergo hemorrhoidectomy

Exclusion Criteria:

previous history of anal surgery
Crohn's anal disease
perianal complex abscess or fistula
uncontrollable medical disease
Tb
HIV
malignancy
immunocompromised
pregnancy
breast feeding
NSAID allergy

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Electronic bidet

Sitz bath

Arm Description

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

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

Outcomes

Primary Outcome Measures

pain score

visual analog scale after hemorrhoidectomy at 1 week

Secondary Outcome Measures

wound healing

wound healing rate at 4 week

convenience

questionnaire survey for convenience of wound management after hemorrhoidectomy

urinary difficulty

IPSS, urinary difficulty questionnaire

Full Information

NCT ID

NCT02353156

First Posted

January 28, 2015

Last Updated

November 10, 2020

Sponsor

Seoul National University Hospital

Collaborators

Daehang Hospital, Coway Co

1. Study Identification

Unique Protocol Identification Number

NCT02353156

Brief Title

Posthemorrhoidectomy Pain Management With Electronic Bidet or Sitz Bath

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 14, 2016 (Actual)

Primary Completion Date

March 28, 2018 (Actual)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

Collaborators

Daehang Hospital, Coway Co

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemorrhoid

Keywords

Hemorrhoidectomy, postoperative pain, Sitz bath, Electronic bidet

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Electronic bidet

Arm Type

Experimental

Arm Description

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

Arm Title

Sitz bath

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Electronic bidet

Intervention Description

electronic bidet after hemorrhoidectomy for relieving pain and inducing wound healing

Intervention Type

Other

Intervention Name(s)

Sitz bath

Intervention Description

sitz bath after hemorrhoidectomy for relieving pain and inducing wound healing

Primary Outcome Measure Information:

Title

pain score

Description

visual analog scale after hemorrhoidectomy at 1 week

Time Frame

1 week

Secondary Outcome Measure Information:

Title

wound healing

Description

wound healing rate at 4 week

Time Frame

4 week

Title

convenience

Description

questionnaire survey for convenience of wound management after hemorrhoidectomy

Time Frame

4 week

Title

urinary difficulty

Description

IPSS, urinary difficulty questionnaire

Time Frame

4 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: the patients who undergo hemorrhoidectomy Exclusion Criteria: previous history of anal surgery Crohn's anal disease perianal complex abscess or fistula uncontrollable medical disease Tb HIV malignancy immunocompromised pregnancy breast feeding NSAID allergy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kyu Joo Park, MD, PhD

Organizational Affiliation

Seoul National University College of Medicine

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

21218033

Citation

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.

Results Reference

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Posthemorrhoidectomy Pain Management With Electronic Bidet or Sitz Bath

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