Effect of Early Warm Water Sitz Bath on Urinary Retention After Hemorrhoidectomy
Primary Purpose
Hemorrhoids, Haemorrhoids, Piles
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
early warm water sitz bath
Regular time warm water sitz bath
Sponsored by
About this trial
This is an interventional other trial for Hemorrhoids focused on measuring hemorrhoidectomy, warm water sitz bath, urinary retention
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Cathay General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
experimental group
control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Effect of early warm water sitz bath on wound pain after hemorrhoidectomy
The secondary objective was the effect of early warm water sitz bath on wound pain after hemorrhoidectomy.This study used a Numerical Rating Scale (NRS) to assess wound pain after hemorrhoidectomy. NRS is the most suitable pain scale for patients after surgery. The patient evaluates his pain on a scale of 0 to 10, where 0 means no pain; 1-3 mild pain; 4-6 moderate pain; 7-10 severe pain ( Karcioglu et al., 2018; Aryolcu, 2014). Li et al. (2007) studied the reliability and validity of the NRS scale and the quantification scale. The results showed that the current (current) pain, the most severe (worst) pain, the least (least) pain and the average (average) pain The reliability of ICC (Interclass correlation coefficient) is .822.
Full Information
NCT ID
NCT04535765
First Posted
June 14, 2020
Last Updated
January 31, 2021
Sponsor
Cathay General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04535765
Brief Title
Effect of Early Warm Water Sitz Bath on Urinary Retention After Hemorrhoidectomy
Official Title
Effect of Early Warm Water Sitz Bath on Urinary Retention After Hemorrhoidectomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cathay General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
In order to ensure that the results of the study are not distorted by humans, this study is a single-blind randomized trial study. The subjects were randomly assigned to the experimental group or the control group with a permuted block randomization. For the sample number calculation, refer to Hedeker, Gibbons & Waternaux (1999) Comparing the time-dependent comparison of the longitudinal design sample size estimates between the two groups, and considering the 20% sample loss rate, the total number of samples is estimated to be 64 (32 in the control group and 32 in the experimental group).
The two groups of patients also received the same conventional treatment, anesthesia and surgery on the night before and on the day of the operation, and the warm water sitz bath was performed at different times after the operation. The warm water sitz bath temperature of the two groups was also 41-43°C daily 3 times (9:00, 13:00, 17:00), 5 minutes each time, and regularly take the same painkillers, stool softeners, and antibiotics. The researchers evaluated the wound pain index on the Numerical Rating Scale (NRS) 6 hours after the operation, 7 hours after the operation, and before and after each warm water sitz bath; After urine, the residual urine volume of the subject was evaluated with a Bladder Scan until the first day after the operation. A total of 8 evaluations were performed: 6 hours after the operation, 7 hours after the operation, and the first day after the operation 8:30, 9:30, 12:30, 13:30, 16:30, 17:30.
During the test, the number of subjects with adverse reactions (vertigo, weakness, sustained wound bleeding greater than 100ml) was greater than 3% of the total number of cases (2 persons). The trial was terminated immediately.
Acceptance conditions:
Age over 20 years old, easy to move, can get out of bed and take a bath.
Symptomatic grade III or IV hemorrhoids diagnosed by the surgeon.
Accept epidural anesthesia.
Perform hemorrhoidectomy.
Those who have clear awareness and are willing to participate in and fill out the research consent form.
Exclusion conditions:
Diseases around the anus (fistula, abscess).
Urinary tract problems (prostate hypertrophy in the past medical history; urinary tract infections on admission routine urine tests, urinary retention as assessed by Bladder Scan).
Take painkillers before surgery.
Statistical methods
Descriptive statistical analysis: Adopt the mean, standard deviation, frequency distribution and percentage to present the basic attributes of the subjects.
Inferential statistics: Chi-square test was used to analyze the categorical variables, and independent sample t-test was used to analyze the continuous variables.
Use the independent sample t test to compare the differences in the average degree of urinary retention and pain between the groups. If the data are not normally distributed, switch to the Mann-Whitney U test without parental analysis to compare the experimental group and the control group before and after bathing Whether there is a difference, p value <0.05 is considered statistically significant.
Use GEE (Generalized Estimating Equation) to check whether there is any difference in the degree of urinary retention and pain in each group.
The use of k-Nearest Neighbours to fill in the missing values is mainly to see that the relevant data measured by the subject in the same group is similar to those of other subjects, and then average the data measured by these similar subjects at the same time Value to fill.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids, Haemorrhoids, Piles, Hemorrhoidal Disease
Keywords
hemorrhoidectomy, warm water sitz bath, urinary retention
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
early warm water sitz bath
Intervention Description
The experimental group started the warm water sitz bath 6 hours after the end of the hemorrhoid surgery.
Intervention Type
Other
Intervention Name(s)
Regular time warm water sitz bath
Intervention Description
According to the routine, the control group started the warm water sitz bath on the first day after the hemorrhoid surgery.
Primary Outcome Measure Information:
Title
Effect of early warm water sitz bath on urinary retention after hemorrhoidectomy
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Effect of early warm water sitz bath on wound pain after hemorrhoidectomy
Description
The secondary objective was the effect of early warm water sitz bath on wound pain after hemorrhoidectomy.This study used a Numerical Rating Scale (NRS) to assess wound pain after hemorrhoidectomy. NRS is the most suitable pain scale for patients after surgery. The patient evaluates his pain on a scale of 0 to 10, where 0 means no pain; 1-3 mild pain; 4-6 moderate pain; 7-10 severe pain ( Karcioglu et al., 2018; Aryolcu, 2014). Li et al. (2007) studied the reliability and validity of the NRS scale and the quantification scale. The results showed that the current (current) pain, the most severe (worst) pain, the least (least) pain and the average (average) pain The reliability of ICC (Interclass correlation coefficient) is .822.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Cathay General Hospital
City
Taipei
ZIP/Postal Code
10630
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Early Warm Water Sitz Bath on Urinary Retention After Hemorrhoidectomy
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