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NCT02048631 Clinical Trial

Analysis Of Sensory Recovery Of Donor Size And Quality Life In Oral Cancer Patients

Oral Cancer Clinical Trial

Official title:
Retrospective Analysis Of Sensory Recovery Of Donor Size And Related Quality Life In Oral Cancer Patients Receiving Free Flap Reconstruction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02048631
Other study ID # KMUH-IRB-20130085
Secondary ID
Status Completed
Phase N/A
First received October 8, 2013
Last updated March 5, 2018
Start date July 2013
Est. completion date June 2014

Study information
Verified date July 2013
Source Kaohsiung Medical University Chung-Ho Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study is to investigate post-surgery sensory impairment and life quality changes in oral cancer patients who underwent free flap (Free Flap) on post-operative 6 months, 12 months, and 24 months, respectively

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date June 2014
Est. primary completion date February 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

1. patients with American Society of Anesthesiologists physical status I-III

2. Older than 20 patients

3. Diagnosis of oral canaer ,requiring free flap reconstruction

Exclusion Criteria:

1. Diagnosis of a serious mental illness involving formal thought disorder (e.g., schizophrenia) documented in medical record

2. Cognitive with dementia, delirium

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung

Sponsors (1)
Lead Sponsor Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary sensory impairment on Donor site comparison the contra-lateral side and donor site; measurement of thermal hyperalgesia with thermal roller temperatures measurement of allodynia with brush and cotton swab measurment of mechanical hyperalgesia with Von Frey filaments sensory impairments with roller wheel up to 2 years
Secondary postoperative life quality using EORTC QLQ C-30 questionnaire . postoperative 6 months to one year, postoperative 1 to 2 years, and over postoperative 2 years
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