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

NCT ID: NCT06339372

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-08-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Group A (standard feeding)

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

Group Type: OTHER

Standard feeding

Intervention Type: DIETARY_SUPPLEMENT

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

Group B (immunonutrition mixture)

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

Group Type: EXPERIMENTAL

Omega 3 and dipeptiven

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Standard feeding

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

Intervention Type: DIETARY_SUPPLEMENT

Omega 3 and dipeptiven

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

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Samar Saed Ramadan

Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Cairo University, Cairo , Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

AP1912-30102

Identifier Type: -

Identifier Source: org_study_id