Scapular Flap Versus Obturator
Is the Maxillectomy Patient's Quality of Life Affected by Palatal Defect Reconstruction Via Scapular Free Flab or Obturator? A Randomized Clinical Trial
1 other identifier
interventional
30
1 country
1
Brief Summary
The aim of this study was to evaluate and compare quality of life (QoL) outcomes of scapular island flap versus maxillary obturator reconstruction after partial maxillectomy. patients indicated for maxillectomy were allocated randomly to two equal-sized groups. Control group patients underwent reconstruction with a surgical obturator, while intervention group patients underwent scapular island flap reconstruction
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedFirst Submitted
Initial submission to the registry
February 9, 2021
CompletedFirst Posted
Study publicly available on registry
February 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2021
CompletedFebruary 12, 2021
February 1, 2021
1.7 years
February 9, 2021
February 9, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
patient quality of life
patient quality of life will evaluated with byversion 4 of UW-QOL
6month
Study Arms (2)
obturator group
ACTIVE COMPARATORpatients with resected maxillary defects were managed with surgical obturator
scapular flap group
ACTIVE COMPARATORInterventions
patient with maxillary cancer will resected and reconstructed
Eligibility Criteria
You may qualify if:
- n0 lymph node
- older than 18ys
You may not qualify if:
- patients who recived radiotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fayoum University
Al Fayyum, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of oral and maxillofaciall surgery
Study Record Dates
First Submitted
February 9, 2021
First Posted
February 12, 2021
Study Start
May 20, 2019
Primary Completion
February 1, 2021
Study Completion
February 20, 2021
Last Updated
February 12, 2021
Record last verified: 2021-02