Cathay General Hospital
Taipei, 10630, Taiwan
NCT Number: NCT04535765
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.
Looking for future studies?
Notify Me20 year and older
All sexes
Interventional
Not applicable
Taipei, 10630, Taiwan
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:
Exclusion conditions:
Statistical methods
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The experimental group started the warm water sitz bath 6 hours after the end of the hemorrhoid surgery.
According to the routine, the control group started the warm water sitz bath on the first day after the hemorrhoid surgery.
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.
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.
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.
Cathay General Hospital
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07034820
Anus Diseases, Cardiovascular Diseases
Bursa, Turkey (Türkiye)
View Trial DetailsNCT06860100
Cardiovascular Diseases, Digestive System Diseases
Van, Tuşba, Turkey (Türkiye)
View Trial DetailsNCT05089500
Cardiovascular Diseases, Digestive System Diseases
Wuhan, Hubei, China
View Trial DetailsNCT01881282
Cardiovascular Diseases, Digestive System Diseases
Beijing, China
View Trial Details