- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04405687
Postoperative Follow up After Head and Face Reconstructive Surgeries
Post-reconstructive Surgeries of Severe Head and Face Deformities: An Observational Follow-up Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200011
- Shanghai Ninth People's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
This clinical study will include patients treated by Prof. Li Qingfeng 's professional team who have undergone major head and face reconstructive surgeries before January 1, 2019.
It is estimated that about 85 patients will be enrolled in this study.
Description
Inclusion Criteria:
- Preoperative facial soft tissue deformities/defects of type III and IV
- Major reconstructive surgery of the head and neck (flap transfer with revision at least once) performed before January 1, 2019.
- Agreed and able to cooperate with the follow-ups, with signed informed consent form or audio recorded informed consent.
Exclusion Criteria:
- Patients with mental illness, reduced cognitive capacity, unable to consent and unable to cooperate.
- Minor patients without legal guardian.
- Not willing to participate; informed consent form not signed.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Severe head and face deformity
|
Three questionnaires, including the 36-Item Short Form Health Survey questionnaire (SF-36), Aesthetic and Functional Status Score of Facial Soft-Tissue Deformities/Defects (A&F) and Euroqol 5 dimensions 5 levels questionnaire (EQ-5D-5L), were conducted to evaluate their quality of life and satisfaction with facial aesthetic and functional status.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SF-36 total score
Time Frame: 12 minutes
|
8 aspects including actual physiological function, desirable physiological function, somatic pain, general health status, vitality, social function, emotional function, mental health; and 1 health indicator(reported health transition) Score ranges from 1-100 for each aspects, with higher score indicating a better quality of life.
|
12 minutes
|
Aesthetic & Functional total score (Patient edition)
Time Frame: 8 minutes
|
3 marks for each aspect; Score ranges from 0-18 for aesthetic status, and 0-21 for functional status, with higher score indicating a better outcome. For overall satisfaction of aesthetic and functional status preoperatively and postoperatively, score ranges from 0-10, with higher score indicating a better outcome. |
8 minutes
|
EQ-5D-5L total score
Time Frame: 2 minutes
|
Assessment of the patients' mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Score ranges from 0-100, with higher score indicating a better outcome. |
2 minutes
|
Collaborators and Investigators
Investigators
- Study Director: Tao Zan, MD, PhD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Follow Up
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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