HemorrhoidsNCT04535765
Effect of Early Warm Water Sitz Bath on Urinary Retention After Hemorrhoidectomy
A study testing early warm water sitz bath and Regular time warm water sitz bath in people with Hemorrhoids and Haemorrhoids, run by Cathay General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hemorrhoids, Haemorrhoids, Piles
- What is being tested?
- early warm water sitz bath and Regular time warm water sitz bath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2020to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Hemorrhoids, Haemorrhoids, Piles, Hemorrhoidal Disease
- Being tested
- early warm water sitz bath, Regular time warm water sitz bath
- Keywords
- hemorrhoidectomy, warm water sitz bath, urinary retention
- Medical subject headings
- Hemorrhoids, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early warm water sitz bathOther
The experimental group started the warm water sitz bath 6 hours after the end of the hemorrhoid surgery.
Regular time warm water sitz bathOther
According to the routine, the control group started the warm water sitz bath on the first day after the hemorrhoid surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Regular time warm water sitz bath |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start1 Jan 2020
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cathay General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535765
- Sponsor's protocol ID
- CGH-P108094
- Status last verified
- Feb 2021
- First submitted
- 14 Jun 2020
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38642473
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Warm Water Sitz Bath on Urinary Retention After Hemorrhoidectomy
- ClinicalTrials.gov ID
- NCT04535765
- Acronym / sponsor ID
- CGH-P108094
- Conditions
- Hemorrhoids, Haemorrhoids, Piles, Hemorrhoidal Disease
- Keywords
- hemorrhoidectomy, warm water sitz bath, urinary retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Cathay General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 2 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: early warm water sitz bathThe 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. |
| control group | Other | Other: Regular time warm water sitz bathThe 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early warm water sitz bathThe experimental group started the warm water sitz bath 6 hours after the end of the hemorrhoid surgery. | Other | experimental group |
| Regular time warm water sitz bathAccording to the routine, the control group started the warm water sitz bath on the first day after the hemorrhoid surgery. | Other | control group |
Primary outcome
Effect of early warm water sitz bath on urinary retention after hemorrhoidectomy
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.
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.
1 secondary outcome
Effect of early warm water sitz bath on wound pain after hemorrhoidectomy
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Derived from this study: PubMed 38642473Liao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early warm water sitz bath and Regular time warm water sitz bath in people with Hemorrhoids and Haemorrhoids, run by Cathay General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of early warm water sitz bath on urinary retention after hemorrhoidectomy (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04535765, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.