Posthemorrhoidectomy Pain Management With Electronic Bidet or Sitz Bath

November 10, 2020 updated by: Kyu Joo Park, Seoul National University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

76

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score
Time Frame: 1 week
visual analog scale after hemorrhoidectomy at 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
wound healing
Time Frame: 4 week
wound healing rate at 4 week
4 week
convenience
Time Frame: 4 week
questionnaire survey for convenience of wound management after hemorrhoidectomy
4 week
urinary difficulty
Time Frame: 4 week
IPSS, urinary difficulty questionnaire
4 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Daehang Hospital
Coway Co

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2016

Primary Completion (Actual)

March 28, 2018

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

January 28, 2015

First Submitted That Met QC Criteria

January 28, 2015

First Posted (Estimate)

February 2, 2015

Study Record Updates

Last Update Posted (Actual)

November 12, 2020

Last Update Submitted That Met QC Criteria

November 10, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-3144

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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