Posthemorrhoidectomy Pain Management With Electronic Bidet or Sitz Bath

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT02353156
• Collaborator: Daehang Hospital (Other), Coway Co (Other)
• Enrollment: 76
• Arms: 2
• Anticipated Duration (Months): 51.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hemorrhoid	Other: Electronic bidet; Other: Sitz bath	Phase 2

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

• Study Type: Interventional
• Anticipated Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Sep 14, 2016
• Actual Primary Completion Date: Mar 28, 2018
• Anticipated Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Electronic bidet Electronic bidet for 3min at early morning for 4 weeks after hemorrhoidectomy	Other: Electronic bidet; electronic bidet after hemorrhoidectomy for relieving pain and inducing wound healing
Active Comparator: Sitz bath Wamr sitz bath for 3min at early morning for 4 weeks after hemorrhoidectomy	Other: Sitz bath; sitz bath after hemorrhoidectomy for relieving pain and inducing wound healing

Outcome Measures

Primary Outcome Measures

1. pain score [1 week]

   visual analog scale after hemorrhoidectomy at 1 week

Secondary Outcome Measures

1. wound healing [4 week]

   wound healing rate at 4 week

2. convenience [4 week]

   questionnaire survey for convenience of wound management after hemorrhoidectomy

3. urinary difficulty [4 week]

   IPSS, urinary difficulty questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Seoul National University Hospital
• Daehang Hospital
• Coway Co

Investigators

• Principal Investigator: Kyu Joo Park, MD, PhD, Seoul National University College of Medicine

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Kyu Joo Park, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02353156
• Other Study ID Numbers: 2014-3144
• First Posted: Feb 2, 2015
• Last Update Posted: Nov 12, 2020
• Last Verified: Nov 1, 2020

• Keywords provided by Kyu Joo Park, Professor, Seoul National University Hospital: Hemorrhoidectomy; postoperative pain; Sitz bath; Electronic bidet
• Additional relevant MeSH terms: Hemorrhoids

Study Results

No Results Posted as of Nov 12, 2020