Scapular Flap Versus Obturator

February 9, 2021 updated by: Shaimaa Mohsen, Fayoum University

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Fayoum, Egypt
        • Fayoum University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • n0 lymph node
  • older than 18ys

Exclusion Criteria:

  • patients who recived radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: obturator group
patients with resected maxillary defects were managed with surgical obturator
Procedure: maxillary cancer resection
patient with maxillary cancer will resected and reconstructed
Active Comparator: scapular flap group
Procedure: maxillary cancer resection
patient with maxillary cancer will resected and reconstructed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient quality of life
Time Frame: 6month
patient quality of life will evaluated with byversion 4 of UW-QOL
6month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2019

Primary Completion (Anticipated)

February 1, 2021

Study Completion (Anticipated)

February 20, 2021

Study Registration Dates

First Submitted

February 9, 2021

First Submitted That Met QC Criteria

February 9, 2021

First Posted (Actual)

February 12, 2021

Study Record Updates

Last Update Posted (Actual)

February 12, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2019 (U.S. NIH Grant/Contract: Chief Medical Office (CMO) Alberta Health Services)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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