Colorectal Surgery
Conditions
Interventions
Intervention Group :Syrup with tributyrin for 14 days
Placebo Group :Syrup with placebo for 14 days
Sponsors
The Chinese University of Hong Kong
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adult patients >=65 years old; 2. Attending Preoperative Anaesthetic Assessment Clinic (POAC) at Prince of Wales Hospital for preoperative assessments, going to have colorectal surgeries for primary colorectal carcinomas; 3. The scheduled date of surgery at least 15 days after the POAC assessment.
Exclusion criteria
Exclusion criteria: 1. Age < 65 years old 2. Unable to give informed consent 3. Colorectal surgery not performed for primary colorectal carcinoma, or additional major procedures planned in the same setting 4. Patients known to have adverse reactions to butyrate 5. Emergency operation or expected date of operation less than 15 days from assessment 6. Patients taking probiotics or butyrate supplements As long as the patients are considered competent to give their own informed consent for surgery, we will accept them to be eligible to give informed consent for this trial because mild MCI is common and often subclinical. In fact, these patients may theoretically be even more likely to derive benefits from butyrate supplementation due to its beneficial effects on neuroinflammation. To minimize confounding effect due to imbalance in MCI between treatment groups due to the small sample size of this study, the randomization will be stratified by whether the patients with and without MCI. Patient with delirium at the time of consultation will be excluded because they are considered incompetent to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability and adherence to preoperative oral butyrate glyceride regimen (defined as =75% of participants achieving =70% adherence, i.e., taking the study intervention for at least 10 days out of 14 days from 14 days before surgery to the day of surgery); | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility metrics (recruitment rate, adherence rate, retention rate);Incidence of postoperative delirium (POD);Duration of postoperative delirium (POD); | — |
Countries
China
Contacts
Public ContactCHU Hiu Man Mandy
The Chinese University of Hong Kong, Department of Acute Intensive Care
Outcome results
None listed