To Compare Complications of Both Techniques in Wise Pattern Reduction Mammaplasty and to Correlate Between Complications and Patient Mediated FactorsNCT04646070
Superomedial Pedicle Versus Inferior Pedicle Techniques in Wise Pattern Reduction Mammaplasty :A Comparison Study
A study testing Reduction mammaplasty in people with To Compare Complications of Both Techniques in Wise Pattern Reduction Mammaplasty and to Correlate Between Complications and Patient Mediated Factors, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
A comparison study between superomedial and Inferior pedicle techniques in wise pattern reduction mammaplasty Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- To Compare Complications of Both Techniques in Wise Pattern Reduction Mammaplasty and to Correlate Between Complications and Patient Mediated Factors
- What is being tested?
- Reduction mammaplasty
- 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 Jan 2020to 20 Jan 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -
Who cannot join
- previous extensive breast surgery Breast cancer
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kafr Elsheikh University Hospital
Kafr ash Shaykh
Rami Ali Abdelkareem Eleiba, Master
About this study
A comparison study between superomedial and Inferior pedicle techniques in wise pattern reduction mammaplasty
Read the detailed description
To compare complications of both techniques in wise pattern reduction mammaplasty and to correlate between complications and patient mediated factors
- Being tested
- Reduction mammaplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduction mammaplastyProcedure or surgery
Also called Superomedial pedicle versus Inferior pedicle techniques in wise pattern reduction mammaplasty
Breast reduction surgery
| Study group | Role | What they receive |
|---|---|---|
| Wise pattern reduction mammaplasty using Inferior pedicle | Active comparator | Wise pattern reduction mammaplasty using Inferior pedicle Receives: Procedure: Reduction mammaplasty |
| Wise pattern reduction mammaplasty using superomedial pedicle | Active comparator | Not described Receives: Procedure: Reduction mammaplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare complications of both techniques including nipple areola complex necrosis
Complications include NAC necrosis and other minor complications including wound dehiscence and seroma or hematoma
Measured: 30 days postoperative
Secondary outcomes (1)
To correlate between complications and patient mediated factors
Patient mediated factors including age, BMI, preoperative hb, suprasternal notch to nipple distance
Measured: 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start20 Jan 2020
- Primary completion20 Jan 2021 (estimated)
- Study completion20 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Compare Complications of Both Techniques in Wise Pattern Reduction Mammaplasty and to Correlate Between Complications and Patient Mediated FactorsStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rami Ali Abdelkareem Eleiba, Kafrelsheikh University
- Investigators
- Safwat Adel hegazy, MD, Study director, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646070
- Sponsor's protocol ID
- Reduction mammaplasty
- Status last verified
- Nov 2020
- First submitted
- 21 Nov 2020
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superomedial Pedicle Versus Inferior Pedicle Techniques in Wise Pattern Reduction Mammaplasty :A Comparison Study
- ClinicalTrials.gov ID
- NCT04646070
- Acronym / sponsor ID
- Reduction mammaplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 20 Jan 2021 (estimated)
- Study completion
- 20 Jan 2021 (estimated)
- First posted
- 27 Nov 2020 (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.
A comparison study between superomedial and Inferior pedicle techniques in wise pattern reduction mammaplasty
Detailed description
To compare complications of both techniques in wise pattern reduction mammaplasty and to correlate between complications and patient mediated factors
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wise pattern reduction mammaplasty using Inferior pedicle | Active comparator | Procedure: Reduction mammaplastyWise pattern reduction mammaplasty using Inferior pedicle |
| Wise pattern reduction mammaplasty using superomedial pedicle | Active comparator | Procedure: Reduction mammaplasty |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- previous extensive breast surgery Breast cancer
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 |
|---|---|---|
| Reduction mammaplastyAlso: Superomedial pedicle versus Inferior pedicle techniques in wise pattern reduction mammaplastyBreast reduction surgery | Procedure or surgery | Wise pattern reduction mammaplasty using Inferior pedicle, Wise pattern reduction mammaplasty using superomedial pedicle |
Primary outcome
To compare complications of both techniques including nipple areola complex necrosis
Time frame: 30 days postoperative
Complications include NAC necrosis and other minor complications including wound dehiscence and seroma or hematoma
1 secondary outcome
To correlate between complications and patient mediated factors
Time frame: 30 days postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Individual participant dataSharing planned: Yes
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.
Safwat Adel hegazy, MD study director
Kafrelsheikh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduction mammaplasty in people with To Compare Complications of Both Techniques in Wise Pattern Reduction Mammaplasty and to Correlate Between Complications and Patient Mediated Factors, run by Kafrelsheikh 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 1 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 27 Nov 2020. 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?
Contact Rami Ali Abdelkareem Eleiba, Master (+2 01028835799, Ramieleiba@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare complications of both techniques including nipple areola complex necrosis (time frame: 30 days postoperative). 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 27 Nov 2020.