| Registry | NCT06339372 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, supportive care |
| Enrollment | 176 (Actual) |
| Sponsor | Cairo University (Other) |
| Conditions | Immunonutrition, Surgical Outcome, Pain, Oral Cavity, Mandibular Tumor |
| Interventions | Standard feeding, Omega 3 and dipeptiven (Dietary supplement) |
| Dates | start 2023-02-01, primary completion 2023-08-01, completion 2023-08-01, first posted 2024-04-01, last updated 2024-04-02 |
| Locations | 1 site in Egypt |
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All trials for Immunonutrition All trials for Surgical Outcome All trials of Standard feeding All trials of Omega 3 and dipeptiven
The aim of this study was to investigate the effect of adding omega 3 and dipeptiven to standard feeding in head and neck patients who will undergo oral cavity tumour resection or mandibular tumour resection (immunonutrrition mixture) on wound infection, fistula formation and length of hospital stay ,total dose of intraoperative and postoperative opioids (opioid consumption and pain incidence ,mortality and other postoperative complications as urinary tract infection (UTI) and pneumonia.
Enhanced Recovery after Surgery (ERAS). A series of components that combine to minimize stress and to facilitate the return of function have been described: these include preoperative preparation and medication, fluid balance, anesthesia and postoperative analgesia, pre- and postoperative nutrition, and mobilization.
Nutrition therapy is the provision of nutrition or nutrients either orally (regular diet, therapeutic diet, e.g. fortified food, oral nutritional supplements) or via enteral nutrition (EN) or parenteral nutrition (PN) to prevent or treat malnutrition.
Head and neck cancer surgery usually means surgery to treat cancer of the mouth, throat or larynx . The surgery is complicated and people often experience problems such as wound infections and wound breakdown, as well as infections such as pneumonia.
The use of a nutritional supplement enriched with Omega 3 fatty acids is associated with a greater preoperative weight loss, reduced postoperative pain and decreased postoperative levels of C reactive protein in patients undergoing Roux-en-Y gastric bypass.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group A (standard feeding) | Other | Dietary Supplement: Standard feeding | Patients received only standard feeding with caloric distribution (45%-50% carbohydrates,20-35% from fats and 10-35% from protein) |
| Group B (immunonutrition mixture) | Experimental | Dietary Supplement: Omega 3 and dipeptiven | Patients received perioperative supplementation with omega 3 and dipeptiven (immunonutrition mixture) plus standard feeding. |
Sex: All, ages: 18 Years to 60 Years
Inclusion Criteria: * Age between 18 and 60 years. * Both sexes. * American Society of Anesthesiologists (ASA) physical status I or II . * Patient undergoing mandibular or oral cavity tumour resection. * Body mass index (BMI) between 18.5-24.9. * Patient with serum albumen above 3 gm. * Patient with written valid consent Exclusion Criteria: * Patient refusal and uncooperative patients. * Patient ASA III or IV. * Age more than 60 or less than 18. * Serum albumen less than 3. * Pre-existing severe malnourishment. * Allergy to test drugs. * Patients on tranquilizers, hypnotics, sedatives and other psychotropic patient on steroids and NSAID.
| Facility | City | Country | Status |
|---|---|---|---|
| Cairo University | Cairo | Egypt |