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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06339372
• Other study ID #: AP1912-30102
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: August 1, 2023

Study information

• Verified date: March 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immunonutrition
• Mandibular Neoplasms
• Oral Cavity
• Pain
• Surgical Outcome

Intervention

Dietary Supplement:
• Standard feeding
Patients received only standard feeding with caloric distribution (45%-50% carbohydrates,20_35% from fats and 10-35% from protein)
• Omega 3 and dipeptiven
Patients received perioperative supplementation with omega 3 and dipeptiven (immunonutrition mixture) plus standard feeding.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

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