Peking Union Medical College Hospital
Beijing, China
Location status: Recruiting
NCT Number: NCT05679661
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Beijing, China
Location status: Recruiting
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: within 7 days after surgery
evaluated by trained investigator
Time frame: within 7 days after surgery
defined according to the US Centers for Disease Control Definition
Time frame: within 30 days after surgery
evaluated by QoR-15 and WHODAS2.0
Time frame: within 30 days after surgery
postoperative complication evaluated using Comprehensive complication index
Time frame: From date of surgery until discharge day, assessed up to 4 weeks
Postoperative length of hospital stay assessed by days
Contact information is provided by the study sponsor or research team.
Huang YuGuang
Other
Effect of Perioperative Immunonutrition Intervention and Oral Decontamination on Postoperative Complications in Elderly: a Prospective Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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