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CompletedNCT02048631Updated Mar 7, 2018

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

An observational study in Oral Cancer, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-07.

Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Ages
20 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Oral Cancer

Keywords

  • oral cancer,Quality of life,Sensory
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In context

Mouth Neoplasms

377 studies on the registry are indexed under Mouth Neoplasms; 126 are open to participants now.

This study's enrollment of 200 is above the median of 90 across 103 observational studies indexed under Mouth Neoplasms.

Browse Mouth Neoplasms studies →

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 281 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Oral Cancer Patients Receiving Free Flap Reconstruction

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • Oral Cancer Patients underwent Free Flap Reconstruction
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What researchers measure

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

    Time frame: up to 2 years

Secondary outcomes

  1. 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

07

Study locations

1 site
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
    Kaohsiung, 807, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02048631
Lead sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Responsible party
Sponsor
First posted
Jan 29, 2014
Start date
Jul 2013
Primary completion
Feb 2014
Completion
Jun 2014
Last update
Mar 7, 2018

Study contacts

Kao Pin Chang, MD,PhD.
study director · Department of Plastic Surgery,Kaohsiung Medical University,Taiwan

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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