Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04535765
Status:
COMPLETED
Last Update Posted:
2021-02-02
First Post:
2020-06-14
Brief Title:
Effect of Early Warm Water Sitz Bath on Urinary Retention After Hemorrhoidectomy
Sponsor:
Cathay General Hospital
Organization:
Cathay General Hospital
Study Overview
Official Title:
Effect of Early Warm Water Sitz Bath on Urinary Retention After Hemorrhoidectomy
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 41-43C daily 3 times 900 1300 1700 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 830 930 1230 1330 1630 1730
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
1 Age over 20 years old easy to move can get out of bed and take a bath
2 Symptomatic grade III or IV hemorrhoids diagnosed by the surgeon
3 Accept epidural anesthesia
4 Perform hemorrhoidectomy
5 Those who have clear awareness and are willing to participate in and fill out the research consent form
Exclusion conditions
1 Diseases around the anus fistula abscess
2 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
3 Take painkillers before surgery
Statistical methods
1 Descriptive statistical analysis Adopt the mean standard deviation frequency distribution and percentage to present the basic attributes of the subjects
2 Inferential statistics Chi-square test was used to analyze the categorical variables and independent sample t-test was used to analyze the continuous variables
3 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 005 is considered statistically significant
4 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
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 41-43C daily 3 times 900 1300 1700 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 830 930 1230 1330 1630 1730
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
1 Age over 20 years old easy to move can get out of bed and take a bath
2 Symptomatic grade III or IV hemorrhoids diagnosed by the surgeon
3 Accept epidural anesthesia
4 Perform hemorrhoidectomy
5 Those who have clear awareness and are willing to participate in and fill out the research consent form
Exclusion conditions
1 Diseases around the anus fistula abscess
2 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
3 Take painkillers before surgery
Statistical methods
1 Descriptive statistical analysis Adopt the mean standard deviation frequency distribution and percentage to present the basic attributes of the subjects
2 Inferential statistics Chi-square test was used to analyze the categorical variables and independent sample t-test was used to analyze the continuous variables
3 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 005 is considered statistically significant
4 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None