MedPath

Perioperative Supplementation With Immunonutrition and Its Impact on Surgical Outcome and Pain in Oral Cavity or Mandibular Tumours

Not Applicable
Completed
Conditions
Immunonutrition
Surgical Outcome
Pain
Mandibular Tumor
Oral Cavity
Interventions
Dietary Supplement: Standard feeding
Dietary Supplement: Omega 3 and dipeptiven
Registration Number
NCT06339372
Lead Sponsor
Cairo University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
176
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
Read More
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.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group A (standard feeding)Standard feedingPatients received only standard feeding with caloric distribution (45%-50% carbohydrates,20-35% from fats and 10-35% from protein)
Group B (immunonutrition mixture)Omega 3 and dipeptivenPatients received perioperative supplementation with omega 3 and dipeptiven (immunonutrition mixture) plus standard feeding.
Primary Outcome Measures
NameTimeMethod
The incidence of wound infection28 days after intervention

Evidence of redness and tenderness of surgical wound with discharge of pus was defined as a wound infection.

Secondary Outcome Measures
NameTimeMethod
The incidence of mortality28 days after intervention

Mortality was measured postoperatively

Fistula formation28 days after intervention

Fistula formation was measured postoperatively.

Length of hospital stay28 days after intervention

Length of hospital stay was measured from admission discharge from hospital

Total dose of intraoperative opioidsIntraoperative

Total dose of intraoperative opioids was calculated in either group

Degree of pain12 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").

Total dose of postoperative opioids12 hours postoperative

Total dose of postoperative opioids was calculated in either group

The incidence of complications12 hours postoperative

Postoperative complications as urinary tract infection (UTI)and pneumonia.

Trial Locations

Locations (1)

Cairo University

🇪🇬

Cairo, Egypt

© Copyright 2025. All Rights Reserved by MedPath