NCT04535765

Brief Summary

Background: Hemorrhoid is one of the most common chronic anorectal diseases. The prevalence rate is about 44%. It occurs in adults aged 45-65 years. Hemorrhoidetomy resection is still the standard treatment for grade III and IV hemorrhoid. Urinary retention is one of the most common complications after hemorrhoid surgery, and the complications occur within 24 hours after surgery. The warm water sitz bath is a routine nursing care after hemorrhoid surgery in the clinic. The purpose is to provide moist heat of the perineum and anus to clean, promote healing and drainage, relieve pain, stimulate urination and promote relaxation. In contrast, all current studies, warm water sitz bath intervention time is the first day after surgery, the complications within 24 hours after surgery are not alleviated. Objective: The main purpose was to use experimental research methods to verify the effect of early warm water sitz bath on urinary retention after hemorrhoidectomy. The secondary objective was the effect of early warm water sitz bath on wound pain after hemorrhoidectomy. Methods: This study was a single-blind randomized trial in which subjects were randomly assigned to an experimental or control group with symptomatic stage III or IV end hemorrhoid who were admitted to the hospital for hemorrhoidectomy. The experimental group started the warm water bath 6 hours after the end of the operation, while the control group started the warm water sitz bath on the first day after the operation. The investigator assessed the amount of residual urine and wound pain index before and after each operation of the warm water sitz bath after surgery, and each subject was evaluated 8 times until 24 hours after surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 2, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

February 2, 2021

Status Verified

February 1, 2021

Enrollment Period

11 months

First QC Date

June 14, 2020

Last Update Submit

January 31, 2021

Conditions

Keywords

hemorrhoidectomywarm water sitz bathurinary retention

Outcome Measures

Primary Outcomes (1)

  • Effect of early warm water sitz bath on urinary retention after hemorrhoidectomy

    The main purpose was to use experimental research methods to verify the effect of early warm water sitz bath on urinary retention after hemorrhoidectomy.This study is expected to use the bladder scan BVI 6100 as a tool for evaluating urinary retention. It is currently used clinically to measure bladder urine volume. Studies have indicated its accuracy, sensitivity, and specificity, with results of 94%, 97%, and 91%, respectively (Attia, Hiligsmann, Hellinckx, Wijnen \& Evers, 2016). Before investigating the receipt, the researcher must go through three bladder volume tester operation tests and measure the bladder urine volume in accordance with the standard procedures of the instrument operation. Measurement of residual urine volume.

    In this study, a Bladder Scan was used to evaluate the residual urine volume 6 hours after the operation, 7 hours after the operation and before and after each warm water sitz bath, a total of 8 times.

Secondary Outcomes (1)

  • Effect of early warm water sitz bath on wound pain after hemorrhoidectomy

    In this study, the wound pain index was evaluated with a Numerical Rating Scale (NRS) 6 hours after the operation, 7 hours after the operation, and before and after each warm water sitz bath, a total of 8 times.

Study Arms (2)

experimental group

EXPERIMENTAL

The experimental group began to perform warm water sitz bath 6 hours after the operation (the day of the operation).Warm water sitz bath temperature is 41-43 ℃, 3 times a day, 5 minutes each time.

Other: early warm water sitz bath

control group

OTHER

The control group began to perform warm water sitz bath at 8:00 in the morning on the first day after the operation as usual.Warm water sitz bath temperature is 41-43 ℃, 3 times a day, 5 minutes each time.

Other: Regular time warm water sitz bath

Interventions

The experimental group started the warm water sitz bath 6 hours after the end of the hemorrhoid surgery.

experimental group

According to the routine, the control group started the warm water sitz bath on the first day after the hemorrhoid surgery.

control group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The age is more than 20 years old, the action is convenient, you can get out of bed and take a bath.
  • Diagnosed as symptomatic grade III or IV hemorrhoid by a surgeon.
  • Accept epidural anesthesia.
  • Perform an open hemorrhoidectomy.
  • After the researcher explains the purpose of the study, the person with a clear consciousness and willing to participate and fill out the study consent form.

You may not qualify if:

  • Disease around the anus (fistula, abscess).
  • Urinary tract problems (in the past, there was a hypertrophy of the prostate; the routine urine test for admission had a urinary tract infection, and the bladder volume tester evaluated urinary retention).
  • Take analgesics before surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cathay General Hospital

Taipei, 10630, Taiwan

Location

Related Publications (1)

  • Liao WC, Cheng YY, Hsu CK, Chiu YC, Chiu HY, Chang SC, Hu SH. Effects of early warm water sitz bath on urinary retention and pain after haemorrhoidectomy: A randomized controlled trial. Int J Nurs Stud. 2024 Jun;154:104765. doi: 10.1016/j.ijnurstu.2024.104765. Epub 2024 Mar 31.

MeSH Terms

Conditions

HemorrhoidsUrinary Retention

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2020

First Posted

September 2, 2020

Study Start

January 1, 2020

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

February 2, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations