Clinical trial NCT06339372: Perioperative Supplementation With Immunonutrition and Its Impact on Surgical Outcome and Pain in Oral Cavity or Mandibular Tumours
Official title: Perioperative Supplementation With Immunonutrition and Its Impact on Surgical Outcome and Pain in Oral Cavity or Mandibular Tumours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunonutrition
Surgical Outcome
Pain
Oral Cavity
Mandibular Tumor
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of wound infection
timeFrame: 28 days after intervention
Secondary outcomes:
measure: Fistula formation
timeFrame: 28 days after intervention
measure: Length of hospital stay
timeFrame: 28 days after intervention
measure: Total dose of intraoperative opioids
timeFrame: Intraoperative
measure: Total dose of postoperative opioids
timeFrame: 12 hours postoperative
measure: Degree of pain
timeFrame: 12 hours postoperative
measure: The incidence of mortality
timeFrame: 28 days after intervention
measure: The incidence of complications
timeFrame: 12 hours postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: