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

NCT06339372 | Completed

• 1 other identifier: AP1912-30102
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunonutrition; Surgical Outcome; Pain; Oral Cavity; Mandibular Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Fistula formation

  28 days after intervention

• Length of hospital stay

  28 days after intervention

• Total dose of intraoperative opioids

  Intraoperative

• Total dose of postoperative opioids

  12 hours postoperative

• Degree of pain

  12 hours postoperative

Study Arms (2)

Group A (standard feeding)

OTHER

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

Dietary Supplement: Standard feeding

Group B (immunonutrition mixture)

EXPERIMENTAL

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

Dietary Supplement: Omega 3 and dipeptiven

Interventions

Standard feeding DIETARY_SUPPLEMENT

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

Group A (standard feeding)

Omega 3 and dipeptiven DIETARY_SUPPLEMENT

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

Group B (immunonutrition mixture)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11796, Egypt

Location

MeSH Terms

Conditions

Pain; Mandibular Neoplasms

Interventions

Docosahexaenoic Acids; alanylglutamine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Jaw Neoplasms; Skull Neoplasms; Bone Neoplasms; Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Jaw Diseases; Mandibular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Cairo University, Cairo , Egypt.

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: February 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)