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Clinical Trials/NCT04752046
NCT04752046UnknownNot Applicable

Is the Maxillectomy Patient's Quality of Life Affected by Palatal Defect Reconstruction Via Scapular Free Flab or Obturator? A Randomized Clinical Trial

Fayoum University1 site in 1 country30 target enrollmentStarted: May 20, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
30
Locations
1
Primary Endpoint
patient quality of life

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •n0 lymph node
  • •older than 18ys

Exclusion Criteria

  • •patients who recived radiotherapy

Arms & Interventions

obturator group

Active Comparator

patients with resected maxillary defects were managed with surgical obturator

Intervention: maxillary cancer resection (Procedure)

scapular flap group

Active Comparator

Intervention: maxillary cancer resection (Procedure)

Outcomes

Primary Outcomes

patient quality of life

Time Frame: 6month

patient quality of life will evaluated with byversion 4 of UW-QOL

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Shaimaa Mohsen

lecturer of oral and maxillofaciall surgery

Fayoum University

Study Sites (1)

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