Study design and patient population
Enrolled patients
A total of 62 patients with fecal incontinence from the ICU of the First Affiliated Hospital of Gannan Medical University from May 2017 to May 2022 were selected and randomly divided into the experimental group and the control group, with 32 cases in the experimental group and 30 cases in the control group. This study was approved by the hospital ethics committee of the First Affiliated Hospital of Gannan Medical University, and the patients’ family signed the informed consent.
Inclusion and exclusion criteria
The inclusion criteria were as follows: (1) All patients were fecal incontinence patients in the ICU; (2) Patients with involuntary bowel movements more than five times a day, with watery or mushy stools; (3) After clinical intervention, the patient still had fecal incontinence. The experimental group included 18 males and 14 females, aged 25 ~ 60 years, with an average of (43.19 ± 3.31) years; the control group included 20 males and 10 females, aged 23 ~ 64 years, with an average of (45.08 ± 3.42) years. There were no significant differences in gender, age and general clinical data between the two groups (P > 0.05), which were comparable.
The exclusion criteria were as follows: (1) patients with perianal infection, anal stenosis, anal injury, and severe hemorrhoids; (2) patients with severe heart, liver, and renal system diseases; (3) patients with incomplete clinical data; (4) patients’ family did not agree to enroll due to privacy concerns.
Research Methods
The experimental group was given a new type of double-capsule fecal catheter device (Haohong Medical Technology Co., Ltd., Xinyu, China), and the control group was given an inner diameter of 8 mm of ordinary fecal catheter device for drainage, and routine digital rectal examination was performed before nursing practice. The schematic diagram of the patented design and physical photos of the double-capsule fecal catheter device can be seen in Figs. 1 and Figs. 2, respectively.
(1) The patients in both groups were placed on the right side of the bed, lying on the left side with their legs flexed to expose the anus. In the experimental group, paraffin oil was smeared before the balloon was placed, and the inner ring of double-capsule fecal catheter device entered the anus laterally. Pull the of double-capsule fecal catheter device slightly to make it straight, revealing the outer air bag, and then inflate the outer air bag with 8 ml, the pressure is 30 cm H2O, the double-capsule fecal catheter device is fixed to the anus, and the fecal storage bag is connected. In the control group, the front end of the catheter was smeared with paraffin oil, the catheter was placed 15 cm into the anus, the balloon was inflated with about 10 ml, the pressure was 30cm H2O, the catheter was slightly pulled, and the closed drainage bottle was connected. (2) The air bag pressure was measured every six hours in both groups to prevent air bag leakage. If the air bag pressure was stable, the air bag pressure was measured once a day. (3) Perianal care twice a day, keep the perineum dry, and change the contaminated dressing in time. (4) Replace the catheter once a week. When replacing, take the lateral position, empty the airbag, and directly pull it out. The fecal storage bag is replaced according to the filling condition. (5) Pay attention to the excretion of stool, whether there is pipeline prolapse, leakage, obstruction, and so on.
Observation Indicator
(1) Patency
The fecal drainage status of the patients are registered daily. For those patients with bowel obstruction, abdominal distension, and obvious perianal leakage, which are regarded as high-risk groups of catheter obstruction, the double-capsule fecal catheter device should be removed, and the ordinary fecal catheter device should be reinserted as appropriate.
(2) Perianal leakage situation
We perform perianal care for patients with fecal incontinence twice a day, and record whether the patient has perianal leakage. Patients with stool leakage will be given perianal scrub care, and the number of cases and times will be recorded. Patients with severe perianal leakage will be given increased scrubbing and even removal of the catheter.
(3) Recording of the dislodgement of the catheter
To observe whether the catheter is prolapsed, re-insert the catheter if necessary, and register the number of dislocations.
Statistical Methods
SPSS 22.0 software was used for data processing and statistical analysis, and Fisher’s exact probability method with four-table data was used to compare the rates between the two groups. P < 0.05 was considered statistically significant.