Elderly patients are vulnerable to postoperative complications. Preoperative malnutrition and poor oral hygiene are risk factors for postoperative complications especially pulmonary complications. This study aims to investigate the feasibility and efficacy of perioperative oral decontamination and immunonutrition supplement on reducing postoperative complications in elderly surgical patients.
This study is a prospective, single center, two-by-two factorial randomized controlled trial to evaluate the feasibility and efficacy of perioperative oral chlorhexidine decontamination and immunonutrition supplementation on postoperative complications in elderly surgical patients. Patients aged 65 years and older who are scheduled for elective non-cardiac surgeries will be recruited and randomized into four groups in 1:1:1:1 ratio (oral decontamination vs routine oral care with/without immunonutrition supplementation).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
590
Patients in the intervention group will receive additional immunonutrition supplementation, which is oral intake of ORAL IMPACT™ 2 servings per day from the day of allocation at the preoperative anesthesia clinic until the day before surgery.
Patients in the intervention group will receive oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3.
Peking Union Medical College Hospital
Beijing, China
RECRUITINGpostoperative pulmonary complications
evaluated by trained investigator
Time frame: within 7 days after surgery
postoperative pneumonia
defined according to the US Centers for Disease Control Definition
Time frame: within 7 days after surgery
postoperative recovery
evaluated by QoR-15 and WHODAS2.0
Time frame: within 30 days after surgery
Comprehensive complication index (CCI)
postoperative complication evaluated using Comprehensive complication index
Time frame: within 30 days after surgery
Length of hospital stay
Postoperative length of hospital stay assessed by days
Time frame: From date of surgery until discharge day, assessed up to 4 weeks
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