A Retrospective Study of Early Postoperative Mobilization in the Recovery of Patients With Oral Head and Neck Tumors Who Underwent Flap Reconstruction

All patients with head and neck cancers and osteomyelitis who underwent vascularized flap reconstruction at Shanghai Ninth People's Hospital (North Campus), Shanghai Jiao Tong University, from February 2020 to July 2021 were the object of a retrospective data collection.Depending on whether they had postoperative early mobilization, all patients were split into experimental and control groups.In the experimental group, patients were split into two groups based on the postoperative day(POD): the POD 0-1 group and the POD >1 group.Comparison and analysis were done on the difference in hospital days and post-operative complication rates between the two groups.

Study Overview

• Status: Completed
• Conditions: Length of Hospital Stay
• Intervention / Treatment: Behavioral: Early Mobilization

• Study Type: Observational
• Enrollment (Actual): 244

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Shanghai Ninth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Early Mobilizationon Recovery After Major Head and Neck Surgery With Flap Reconstruction

Description

Inclusion Criteria:

1. Patients with head and neck diseases undergoing flap reconstruction and repair
2. Patients with complete data preservation and consent
3. Patients who follow medical advice during hospitalization

Exclusion Criteria:

1. Patients who survived less than 1 month after surgery
2. Patients with other tumors before surgery 3, mental patients, audio-visual impairment or uncooperative patients

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Early MobilizatioN	Behavioral: Early Mobilization; The time the patient began to sit, stand, and walk after surgery is earlier than traditional model.
conventional Mobilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay after surgery	The time span between the end of surgery and hospital discharge is defined as the length of hospital stay after surgery.	February 2020 to July 2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pulmonary infection rate	The pulmonary infection rate is calculated as the proportion of hospitalized patients who had pulmonary infections over all patients.	February 2020 to July 2021
deep vein thrombosis rate	The deep vein thrombosis rate is calculated as the proportion of hospitalized patients who had deep vein thrombosis over all patients.	February 2020 to July 2021
flap crisis rate	The flap crisis rate is calculated as the proportion of hospitalized patients who had flap crisis over all patients.	February 2020 to July 2021

Collaborators and Investigators

• Sponsor: Jie He, MD

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: May 1, 2023
• First Submitted That Met QC Criteria: May 1, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 654321

Drug and device information, study documents

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