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.

Study Overview

• Status: Completed
• Conditions: Pain; Oral Cavity; Immunonutrition; Surgical Outcome; Mandibular Tumor
• Intervention / Treatment: Dietary supplement: Standard feeding; Dietary supplement: Omega 3 and dipeptiven

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.

• Study Type: Interventional
• Enrollment (Actual): 176
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11796
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group A (standard feeding); Patients received only standard feeding with caloric distribution (45%-50% carbohydrates,20-35% from fats and 10-35% from protein)	Dietary supplement: Standard feeding; Patients received only standard feeding with caloric distribution (45%-50% carbohydrates,20_35% from fats and 10-35% from protein)
Experimental: Group B (immunonutrition mixture); Patients received perioperative supplementation with omega 3 and dipeptiven (immunonutrition mixture) plus standard feeding.	Dietary supplement: Omega 3 and dipeptiven; Patients received perioperative supplementation with omega 3 and dipeptiven (immunonutrition mixture) plus standard feeding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of wound infection	Evidence of redness and tenderness of surgical wound with discharge of pus was defined as a wound infection.	28 days after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fistula formation	Fistula formation was measured postoperatively.	28 days after intervention
Length of hospital stay	Length of hospital stay was measured from admission discharge from hospital	28 days after intervention
Total dose of intraoperative opioids	Total dose of intraoperative opioids was calculated in either group	Intraoperative
Total dose of postoperative opioids	Total dose of postoperative opioids was calculated in either group	12 hours postoperative
The incidence of mortality	Mortality was measured postoperatively	28 days after intervention
The incidence of complications	Postoperative complications as urinary tract infection (UTI)and pneumonia.	12 hours postoperative
Degree of pain	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").	12 hours postoperative

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 30, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Stomatognathic Diseases; Bone Diseases; Jaw Diseases; Mandibular Diseases; Skull Neoplasms; Bone Neoplasms; Jaw Neoplasms; Mandibular Neoplasms
• Other Study ID Numbers: AP1912-30102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No