Clinical trial NCT04535765: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhoids
Haemorrhoids
Piles
Hemorrhoidal Disease
Keywords: hemorrhoidectomy
warm water sitz bath
urinary retention
Lead sponsor: Cathay General Hospital
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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:

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 \<0.05 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.

Eligibility criteria: Inclusion Criteria:

1. The age is more than 20 years old, the action is convenient, you can get out of bed and take a bath.
2. Diagnosed as symptomatic grade III or IV hemorrhoid by a surgeon.
3. Accept epidural anesthesia.
4. Perform an open hemorrhoidectomy.
5. 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:

1. Disease around the anus (fistula, abscess).
2. 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).
3. Take analgesics before surgery.

Primary outcomes:
measure: Effect of early warm water sitz bath on urinary retention after hemorrhoidectomy
timeFrame: 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:
measure: Effect of early warm water sitz bath on wound pain after hemorrhoidectomy
timeFrame: 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.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Cathay General Hospital
Study officials:
References: