Prospective interventional study assessing the effectiveness on ameliorating surgical stress and the enhancement of recovery after surgery by Miyagi Cancer Center Head and Neck ERAS Protocol (MCC-HN ERAS)

Not Applicable

• Conditions: Head and Neck Cancers

• Registration Number: JPRN-UMIN000030467
• Lead Sponsor: Miyagi Cancer Center

Brief Summary

The duration of hospital stay: Median 25 days. The duration until completion of the discharge criteria: Median 17 days. Early mobilization: 86.0% (POD1), 96.5% (POD2). Enteral nutrition: 80.1% (POD1), 100% (POD2). Postoperative pain: Mean VAS scores of 1.51 to 3.13. Clavien Dindo grade II or higher postoperative complications: 27.6% of the patients. The mean QOR40 score: 179.6 preoperatively, 146.1 at POD3, and 167.8 at POD7.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-19
• Study Completion: 2019-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with hypersensitivity to dexamethasone. 2) Patients with active infectious diseases such as tuberculosis, viral infection and mycosis. 3) Patients with thrombosis. 4) Patients with poor-controlled diabetes mellitus; e.g. insulin dependent. 5) Patients with uncontrolled psycogenic disease, such as depression. 6) Patients with active peptic ulcer. 7) Patients with uncontrolled glaucoma. 8) Patients with regular use of oral steroid for such conditions as autoimmune disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)Postoperative period to discharge. 2)Postoperative period to the day meeting the discharge criteria.

Secondary Outcome Measures

Name	Time	Method
1) Postoperative patients' satisfaction rating (QoR-40 score) 2) Inflammatory response as surgical invasiveness 3) Pain control 4) Postoperative nausea and vomiting 5) Postoperative period until the commencement of enteral nutrition 6) Nutritional intake independence 7) Daily activities independence 8) Water balance 9) Organ disorder 10) Postoperative complication 11) Protocol compliance rate