Maxillary Defect ReconstructionNCT04752046
Scapular Flap Versus Obturator
A study testing maxillary cancer resection in people with Maxillary Defect Reconstruction, run by Fayoum University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Maxillary Defect Reconstruction
- What is being tested?
- maxillary cancer resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2019to 20 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- n0 lymph node
- older than 18ys
Who cannot join
- patients who recived radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Maxillary Defect Reconstruction
- Being tested
- maxillary cancer resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maxillary cancer resectionProcedure or surgery
patient with maxillary cancer will resected and reconstructed
| Study group | Role | What they receive |
|---|---|---|
| obturator group | Active comparator | patients with resected maxillary defects were managed with surgical obturator Receives: Procedure: maxillary cancer resection |
| scapular flap group | Active comparator | Not described Receives: Procedure: maxillary cancer resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient quality of life
patient quality of life will evaluated with byversion 4 of UW-QOL
Measured: 6month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start20 May 2019
- Primary completion1 Feb 2021 (estimated)
- Study completion20 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Defect ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohsen, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752046
- Sponsor's protocol ID
- 2019
- Status last verified
- Feb 2021
- First submitted
- 9 Feb 2021
- Last updated
- 12 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Maxillectomy Patient's Quality of Life Affected by Palatal Defect Reconstruction Via Scapular Free Flab or Obturator? A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04752046
- Acronym / sponsor ID
- 2019
- Conditions
- Maxillary Defect Reconstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 20 Feb 2021 (estimated)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obturator group | Active comparator | Procedure: maxillary cancer resectionpatients with resected maxillary defects were managed with surgical obturator |
| scapular flap group | Active comparator | Procedure: maxillary cancer resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- n0 lymph node
- older than 18ys
Key exclusion criteria (1 listed)
- patients who recived radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maxillary cancer resectionpatient with maxillary cancer will resected and reconstructed | Procedure or surgery | obturator group, scapular flap group |
Primary outcome
patient quality of life
Time frame: 6month
patient quality of life will evaluated with byversion 4 of UW-QOL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
Related trials for Maxillary Defect Reconstruction
Not yet recruitingObservational study
Tongue and Occlusal Pressure Performance and Dietary Habits in Maxillectomy Patients With Obturator Prostheses
Maxillary Obturators, Maxillary Defect Reconstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing maxillary cancer resection in people with Maxillary Defect Reconstruction, run by Fayoum University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient quality of life (time frame: 6month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.