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

NCT06339372 — Not applicable, Completed, 176 participants, Cairo University

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RegistryNCT06339372
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, supportive care
Enrollment176 (Actual)
SponsorCairo University (Other)
ConditionsImmunonutrition, Surgical Outcome, Pain, Oral Cavity, Mandibular Tumor
InterventionsStandard feeding, Omega 3 and dipeptiven (Dietary supplement)
Datesstart 2023-02-01, primary completion 2023-08-01, completion 2023-08-01, first posted 2024-04-01, last updated 2024-04-02
Locations1 site in Egypt

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Group A (standard feeding)OtherDietary Supplement: 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)ExperimentalDietary Supplement: Omega 3 and dipeptivenPatients received perioperative supplementation with omega 3 and dipeptiven (immunonutrition mixture) plus standard feeding.
  • 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.

+Outcome measures

Primary outcomes

  • 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 outcomes

  • Fistula formation [28 days after intervention]: Fistula formation was measured postoperatively.
  • 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
  • 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").
  • 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.

+Eligibility

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.

+Locations (1)

FacilityCityCountryStatus
Cairo UniversityCairoEgypt

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