Perioperative Immunonutrition Intervention and Oral Decontamination in Elderly Surgical Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: immunonutrition, oral chlorhexidine decontamination.
- Who it may be relevant to
- Registry conditions: Postoperative Complications. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Perioperative Immunonutrition Intervention and Oral Decontamination on Postoperative Complications in Elderly: a Prospective Randomized Controlled Trial
Overview
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.
Detailed description
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).
Interventions
- Dietary supplement immunonutrition
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. - Behavioral oral chlorhexidine decontamination
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.
Primary outcome measures
- postoperative pulmonary complications [Time frame: within 7 days after surgery]
Secondary outcome measures (4)
- postoperative pneumonia [Time frame: within 7 days after surgery]
- postoperative recovery [Time frame: within 30 days after surgery]
- Comprehensive complication index (CCI) [Time frame: within 30 days after surgery]
- Length of hospital stay [Time frame: From date of surgery until discharge day, assessed up to 4 weeks]
Eligibility criteria
Inclusion criteria
- age≥65 years;
- undergoing non-cardiac surgery (expected duration >2 hours);
- scheduled for general anesthesia and endotracheal intubation;
- ASA classification I-IV;
- with intermediate to high risk of respiratory complications assessed by ARISCAT score (Assess Respiratory Risk in Surgical Patients in Catalonia);
- inform consent obtained
Exclusion criteria
- emergency surgery;
- preoperative pneumonia;
- allergic to chlorhexidine;
- severe hepatic/renal dysfunction, incapable of oral feeding, with autoimmune diseases, taking immunosuppressant or immunoregulation medications, or with other contraindication to immunonutrition supplementation;
- expected intervention of immunonutrition<3 days.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT05679661 · K2870