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临床试验/NCT04535765
NCT04535765已完成不适用

Effect of Early Warm Water Sitz Bath on Urinary Retention After Hemorrhoidectomy

Cathay General Hospital2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
2
主要终点
Effect of early warm water sitz bath on urinary retention after hemorrhoidectomy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Effect of early warm water sitz bath on urinary retention after hemorrhoidectomy

时间窗: 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.

次要结局

  • Effect of early warm water sitz bath on wound pain after hemorrhoidectomy(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.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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