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

March 5, 2018 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Oral Cancer Patients Receiving Free Flap Reconstruction

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Oral Cancer Patients underwent Free Flap Reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensory impairment on Donor site
Time Frame: up to 2 years
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 Outcome Measures

Outcome Measure
Time Frame
postoperative life quality using EORTC QLQ C-30 questionnaire .
Time Frame: postoperative 6 months to one year, postoperative 1 to 2 years, and over postoperative 2 years
postoperative 6 months to one year, postoperative 1 to 2 years, and over postoperative 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

  • Study Director: Kao Pin Chang, MD,PhD., Department of Plastic Surgery,Kaohsiung Medical University,Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

October 8, 2013

First Submitted That Met QC Criteria

January 28, 2014

First Posted (Estimate)

January 29, 2014

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 5, 2018

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMUH-IRB-20130085

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.

Clinical Trials on Oral Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe