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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05851833
Other study ID # 654321
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date August 1, 2021

Study information

Verified date May 2023
Source Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 244
Est. completion date August 1, 2021
Est. primary completion date July 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Shanghai Ninth People's Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Jie He, MD

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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