Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Posthemorrhoidectomy Pain Management With Electronic Bidet or Sitz Bath

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Daehang Hospital
Coway Co
Information provided by (Responsible Party):
Kyu Joo Park, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT02353156
First received: January 28, 2015
Last updated: October 16, 2016
Last verified: October 2016
  Purpose
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 Intervention Phase
Hemorrhoid
Other: Electronic bidet
Other: Sitz bath
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • pain score [ Time Frame: 1 week ]
    visual analog scale after hemorrhoidectomy at 1 week


Secondary Outcome Measures:
  • wound healing [ Time Frame: 4 week ]
    wound healing rate at 4 week

  • convenience [ Time Frame: 4 week ]
    questionnaire survey for convenience of wound management after hemorrhoidectomy

  • urinary difficulty [ Time Frame: 4 week ]
    IPSS, urinary difficulty questionnaire


Estimated Enrollment: 76
Study Start Date: January 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02353156

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
  More Information

Publications:
Responsible Party: Kyu Joo Park, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02353156     History of Changes
Other Study ID Numbers: 2014-3144
Study First Received: January 28, 2015
Last Updated: October 16, 2016

Keywords provided by Seoul National University Hospital:
Hemorrhoidectomy
postoperative pain
Sitz bath
Electronic bidet

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 27, 2017