NCT05851833

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

1.4 years

First QC Date

May 1, 2023

Last Update Submit

May 1, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • pulmonary infection rate

    February 2020 to July 2021

  • deep vein thrombosis rate

    February 2020 to July 2021

  • flap crisis rate

    February 2020 to July 2021

Study Arms (2)

Early MobilizatioN

Behavioral: Early Mobilization

conventional Mobilization

Interventions

The time the patient began to sit, stand, and walk after surgery is earlier than traditional model.

Early MobilizatioN

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Interventions

Early Ambulation

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate chief physician

Study Record Dates

First Submitted

May 1, 2023

First Posted

May 10, 2023

Study Start

March 1, 2020

Primary Completion

July 31, 2021

Study Completion

August 1, 2021

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations