Posthemorrhoidectomy Pain Management With Electronic Bidet or Sitz Bath

Hemorrhoid Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02353156
• Other study ID #: 2014-3144
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: September 14, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 76
• Est. completion date: December 31, 2020
• Est. primary completion date: March 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhoid
• Hemorrhoids

Intervention

Other:
• Electronic bidet
electronic bidet after hemorrhoidectomy for relieving pain and inducing wound healing
• Sitz bath
sitz bath after hemorrhoidectomy for relieving pain and inducing wound healing

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	Coway Co, Daehang Hospital

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score	visual analog scale after hemorrhoidectomy at 1 week	1 week
Secondary	wound healing	wound healing rate at 4 week	4 week
Secondary	convenience	questionnaire survey for convenience of wound management after hemorrhoidectomy	4 week
Secondary	urinary difficulty	IPSS, urinary difficulty questionnaire	4 week