The goal of this clinical trial is to investigate if Shouhui Tongbian Capsules can shorten intestinal function recovery time (exhaust/defecation time) and improve defecation quality in perioperative patients, and to evaluate its safety and comfort advantages during the perioperative period. The study involves participants aged 18-70 years, both male and female, with ASA grade I-III scheduled for elective surgery. The main questions it aims to answer are:
Can Shouhui Tongbian Capsules shorten the intestinal function recovery time (first flatus and defecation time) in perioperative patients? Can Shouhui Tongbian Capsules improve defecation quality (assessed by Bristol Stool Scale) and reduce inflammatory factor levels (e.g., IL-6, TNF-α)? Researchers will compare the experimental group (receiving Shouhui Tongbian Capsules 2 pills twice daily from admission to the night before surgery, then resuming after bowel sound recovery and oral intake postoperatively, with a 3-day post-discharge regimen) to the control group (receiving routine perioperative care including diet control and standard bowel-cleansing drugs) to see if the capsules show superior efficacy in intestinal function recovery and safety.
Participants will:
Take Shouhui Tongbian Capsules according to the specified regimen (experimental group) or receive routine care (control group).
Have their exhaust/defecation status recorded every 6 hours postoperatively. Undergo blood tests for liver/kidney function and inflammatory factors on the day before surgery and day 3 postoperatively.
Complete questionnaires on bowel preparation comfort and postoperative defecation satisfaction.
Aged 18-70 years, regardless of gender;
ASA class I-III, elective surgery patients;
Signed the informed consent form.
None
Parallel
Shouhui Tongbian Capsules
Drug2 pills twice daily from admission to the night before surgery, then resuming after bowel sound recovery and oral intake postoperatively, with a 3-day post-discharge regimen
Postoperative intestinal function recovery time
Observe and record the postoperative intestinal function recovery time of the two groups of patients (including the time of first exhaust and defecation). The shorter the time, the better.
Total duration of intestinal function recovery
Observe and record the total duration of intestinal function recovery of the two groups of patients. The shorter the time, the better.
Defecation trait score
Observe and record the defecation trait score of the two groups of patients (using the Bristol Stool Scale). Seven types of stools based on shape and consistency, with type 1 being the hardest and type 7 being the softest
Levels of inflammatory factors
Measure the levels of inflammatory factors (such as IL-6, TNF-α, etc.).
Adverse event rate
Record adverse events occurring in the two groups of patients during the study period, including gastrointestinal discomfort (nausea, vomiting, abdominal pain, etc.), changes in liver and kidney function indicators, etc.
Comfort of intestinal preparation satisfaction questionnaire
Evaluate the differences in comfort of intestinal preparation satisfaction between the two groups of patients through questionnaires. The higher the score, the better.
Postoperative defecation satisfaction questionnaire
Evaluate the differences in postoperative defecation satisfaction between the two groups of patients through questionnaires. The higher the score, the better.
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Shandong University
Lead sponsor
Shandong Public Health Clinical Center
Collaborator
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