Immunonutrition, Mandibular Tumor, Oral Cavity, Pain, Surgical Outcome
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTStandard feeding
Patients received only standard feeding with caloric distribution (45%-50% carbohydrates,20\_35% from fats and 10-35% from protein)
DIETARY_SUPPLEMENTOmega 3 and dipeptiven
Patients received perioperative supplementation with omega 3 and dipeptiven (immunonutrition mixture) plus standard feeding.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of wound infection | 28 days after intervention | Evidence of redness and tenderness of surgical wound with discharge of pus was defined as a wound infection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | 28 days after intervention | Length of hospital stay was measured from admission discharge from hospital |
| Total dose of intraoperative opioids | Intraoperative | Total dose of intraoperative opioids was calculated in either group |
| Total dose of postoperative opioids | 12 hours postoperative | Total dose of postoperative opioids was calculated in either group |
| Fistula formation | 28 days after intervention | Fistula formation was measured postoperatively. |
| The incidence of mortality | 28 days after intervention | Mortality was measured postoperatively |
| The incidence of complications | 12 hours postoperative | Postoperative complications as urinary tract infection (UTI)and pneumonia. |
| Degree of pain | 12 hours postoperative | Postoperative pain will be assessed by visual analogue scale (VAS) every 4 h. for 12 h. Patients reporting VAS score (more than 3) will receive rescue analgesics. VAS (0 represents no pain while 10 represents the worst pain imaginable). |
Countries
Egypt
Outcome results
None listed