NCT02048631

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 29, 2014

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

March 7, 2018

Status Verified

July 1, 2013

Enrollment Period

7 months

First QC Date

October 8, 2013

Last Update Submit

March 5, 2018

Conditions

Oral Cancer

Keywords

oral cancer,Quality of life,Sensory

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

Oral Cancer Patients underwent Free Flap Reconstruction

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Oral Cancer Patients Receiving Free Flap Reconstruction

You may qualify if:

  • patients with American Society of Anesthesiologists physical status I-III
  • Older than 20 patients
  • Diagnosis of oral canaer ,requiring free flap reconstruction

You may not qualify if:

  • Diagnosis of a serious mental illness involving formal thought disorder (e.g., schizophrenia) documented in medical record
  • Cognitive with dementia, delirium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Study Officials

  • Kao Pin Chang, MD,PhD.

    Department of Plastic Surgery,Kaohsiung Medical University,Taiwan

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2013

First Posted

January 29, 2014

Study Start

July 1, 2013

Primary Completion

February 1, 2014

Study Completion

June 1, 2014

Last Updated

March 7, 2018

Record last verified: 2013-07

Locations

TW(1)