Scapular Flap Versus Obturator | NCT04752046

Studies
Scapular Flap Versus Obturator

NCT04752046

Sponsor

Fayoum University

Status

Unknown status

Last Update Posted

Feb 12, 2021Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Maxillary Defect Reconstruction

Interventions

maxillary cancer resection

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 20, 2019Actual

Primary Completion Date

Feb 1, 2021Estimated

Completion Date

Feb 20, 2021Estimated

First Submitted Date

Feb 9, 2021

First Submission Date that Met QC Criteria

Feb 9, 2021

First Posted Date

Feb 12, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2021

Last Update Posted Date

Feb 12, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shaimaa Mohsen, lecturer of oral and maxillofaciall surgery, Fayoum UniversityPrincipal Investigator

Lead Sponsor

Fayoum UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
obturator group	Active Comparator	patients with resected maxillary defects were managed with surgical obturator	Procedure: maxillary cancer resection
scapular flap group	Active Comparator		Procedure: maxillary cancer resection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
maxillary cancer resection	Procedure	patient with maxillary cancer will resected and reconstructed	obturator group scapular flap group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

n0 lymph node
older than 18ys

Exclusion Criteria:

patients who recived radiotherapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fayoum University		Al Fayyum			Egypt