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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT02048631
First received: October 8, 2013
Last updated: January 28, 2014
Last verified: July 2013
  Purpose

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


Condition
Oral Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Analysis Of Sensory Recovery Of Donor Size And Related Quality Life In Oral Cancer Patients Receiving Free Flap Reconstruction

Resource links provided by NLM:


Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:

Primary Outcome Measures:
  • sensory impairment on Donor site [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: July 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Oral Cancer Patients underwent Free Flap Reconstruction

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Oral Cancer Patients Receiving Free Flap Reconstruction

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02048631

Contacts
Contact: Kao Pin Chang, MD, PhD 0988354591 kapich@kmu.edu.tw

Locations
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital Recruiting
Kaohsiung, Taiwan, 807
Contact: Kao Pin Chang, MD.,PhD.    0988354591      
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
Study Director: Kao Pin Chang, MD,PhD. Department of Plastic Surgery,Kaohsiung Medical University,Taiwan
  More Information

No publications provided

Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT02048631     History of Changes
Other Study ID Numbers: KMUH-IRB-20130085
Study First Received: October 8, 2013
Last Updated: January 28, 2014
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
oral cancer,Quality of life,Sensory

Additional relevant MeSH terms:
Mouth Neoplasms
Lip Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Lip Diseases

ClinicalTrials.gov processed this record on October 19, 2014