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

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

Mandibular Tumor
Oral Cavity
Surgical Outcome
Pain
Immunonutrition

Treatments

Dietary Supplement: Standard feeding
Dietary Supplement: Omega 3 and dipeptiven

Study type

Interventional

Funder types

Other

Identifiers

NCT06339372
AP1912-30102

Details and patient eligibility

About

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.

Full 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.

Enrollment

176 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

176 participants in 2 patient groups

Group A (standard feeding)
Other group
Description:
Patients received only standard feeding with caloric distribution (45%-50% carbohydrates,20-35% from fats and 10-35% from protein)
Treatment:
Dietary Supplement: Standard feeding
Group B (immunonutrition mixture)
Experimental group
Description:
Patients received perioperative supplementation with omega 3 and dipeptiven (immunonutrition mixture) plus standard feeding.
Treatment:
Dietary Supplement: Omega 3 and dipeptiven

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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