Postoperative gastrointestinal dysfunction (POGD)
Conditions
Interventions
Control Group:Conventional abdominal massage
Experimental Group:Take Shouhui Tongbian capsules with warm boiled water before and after surgery
conventional abdominal massage
Sponsors
The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 75 years; gender not limited; 2.Patients undergoing treatment in orthopedics or gynecology, with a postoperative bed rest period of at least 2 days (including the day of surgery), and a postoperative hospital stay of >=4 days, mainly resting in bed during the hospital stay; 3.Agree to receive postoperative pain pump therapy; 4.Patient agrees to participate and voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Allergic to any component or excipient of Shouhui Tongbian capsules; 2.History of liver damage caused by He Shou Wu or any He Shou Wu-containing preparations; 3.Screening laboratory tests indicating abnormal liver function: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times the upper limit of normal; 4.Unable to orally take the investigational drug or solid food; 5.Need for emergency surgery; 6.History of intestinal obstruction; 7.History of diagnosed organic bowel disease that may affect efficacy evaluation, as determined by the investigator, such as intestinal tuberculosis, inflammatory bowel disease, or colon cancer; 8.Expected intraoperative blood loss >=500 ml; 9.Systemic or other severe infections; 10.Physical status classification (ASA) greater than 3; 11.Uncontrolled diabetes (HbA1c >= 8% during screening); 12.Rheumatic diseases with gastrointestinal reactions; 13.Long-term use of opioid drugs, defined by the American Pain Society as using opioids at least 90 days daily or nearly every day; 14.Severe primary diseases of the heart, brain, liver, kidney, lungs, hematopoietic system, or other conditions deemed inappropriate for participation by the investigator; 15.Mental or neurological disorders, unable to express intentions clearly; 16.Use of medications that affect gastrointestinal motility within 7 days prior to screening, including but not limited to dopamine receptor antagonists, 5-HT4 receptor agonists, opioid receptor agonists, opioid receptor antagonists, motilin receptor agonists, cholecystokinin (CCK) receptor antagonists; 17.Acute or chronic diarrhea; 18.History of acute or chronic infectious diseases such as hepatitis B, hepatitis C, HIV, or tuberculosis; 19.Participation in other interventional drug or medical device clinical trials within 1 month before screening; 20.Pregnant or breastfeeding women, with a plan for pregnancy within 3 months after the trial; 21.Other reasons deemed by the investigator as unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first spontaneous bowel movement post-surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of spontaneous bowel movements within 24 hours, 3 days, and one week postoperatively compared to baseline;Time to recovery of bowel sounds after surgery;This study aimed to assess the associations between the type of constipation or surgery, treatment strategies, dosage and administration, and the corresponding therapeutic efficacy.;Incidence of postoperative gastrointestinal dysfunction;Postoperative Bowel Movement Score; | — |
Countries
China
Contacts
Public ContactXiaofei Zheng
The First Affiliated Hospital of Jinan University (Guangzhou Overseas Chinese Hospital)
Outcome results
None listed