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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD) | Experimental | Patients will receive immunonutrition supplement of ORAL IMPACTâ„¢ 2 servings per day from the day of allocation at the preoperative anesthesia clinic until the day before surgery and oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3. |
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| Group B (immunonutrition and routine oral care, IN&RC) | Experimental | Patients will receive immunonutrition supplement of ORAL IMPACTâ„¢ 2 servings per day from the day of allocation at the preoperative anesthesia clinic until the day before surgery and routine oral care. |
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| Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&CD) | Experimental | Patients will be advised to follow a standard nutrition advice with a total intake of 30kcal/kg/d and protein intake of 1.2g/kg/d. Patients will also receive oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3. |
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| Group D (routine nutrition advice and routine oral care, RN&RC) | No Intervention | Patients will be advised to follow a standard nutrition advice and routine oral care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immunonutrition | Dietary Supplement | Patients in the intervention group will receive additional immunonutrition supplementation, which is oral intake of ORAL IMPACTâ„¢ 2 servings per day from the day of allocation at the preoperative anesthesia clinic until the day before surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pulmonary complications | evaluated by trained investigator | within 7 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pneumonia | defined according to the US Centers for Disease Control Definition | within 7 days after surgery |
| postoperative recovery | evaluated by QoR-15 and WHODAS2.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu Che, MD | Contact | 69152020 | tracymaobao@126.com | |
| Jiawen Yu, MD | Contact | 69152020 | jiawen_yu@foxmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuguang Huang | Peking Union Medical College Hospital (CAMS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000093702 | Immunonutrition Diet |
| ID | Term |
|---|---|
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| oral chlorhexidine decontamination | Behavioral | 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. |
|
| within 30 days after surgery |
| Comprehensive complication index (CCI) | postoperative complication evaluated using Comprehensive complication index | within 30 days after surgery |
| Length of hospital stay | Postoperative length of hospital stay assessed by days | From date of surgery until discharge day, assessed up to 4 weeks |