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Completed

NCT Number: NCT06339372

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard feeding

Dietary Supplement

Patients received only standard feeding with caloric distribution (45%-50% carbohydrates,20_35% from fats and 10-35% from protein)

Omega 3 and dipeptiven

Dietary Supplement

Patients received perioperative supplementation with omega 3 and dipeptiven (immunonutrition mixture) plus standard feeding.

Primary outcomes

  1. The incidence of wound infection

    Time frame: 28 days after intervention

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

Secondary outcomes

  1. Fistula formation

    Time frame: 28 days after intervention

    Fistula formation was measured postoperatively.

  2. Length of hospital stay

    Time frame: 28 days after intervention

    Length of hospital stay was measured from admission discharge from hospital

  3. Total dose of intraoperative opioids

    Time frame: Intraoperative

    Total dose of intraoperative opioids was calculated in either group

  4. Total dose of postoperative opioids

    Time frame: 12 hours postoperative

    Total dose of postoperative opioids was calculated in either group

  5. Degree of pain

    Time frame: 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").

  6. The incidence of mortality

    Time frame: 28 days after intervention

    Mortality was measured postoperatively

  7. The incidence of complications

    Time frame: 12 hours postoperative

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 1, 2024
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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