Breast HypertrophyNCT03669679
Comparison of Superomedial and Inferior Pedicle Techniques in Mammaplasty
A study testing Breast reduction in people with Breast Hypertrophy, run by Assiut University.
Trial summary
The aim of this study is to evaluate Superomedial pedicle and Inferior pedicle techniques in breast reduction for Egyptian females and compare between both pedicles regarding cosmetic outcomes, possible complications, patient satisfaction and time of operation. Read more about this study
- Who is it for?
- Ages 22 to 50 years, women only
- Conditions the study is for
- Breast Hypertrophy
- What is being tested?
- Breast reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 30 May 2018
- 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 22 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Bilateral breast hypertrophy
Who cannot join
- Congenital breast anomalies.
- Pregnant, lactating or smoker patient.
- Previous breast reductions.
- Co-morbid diseases e.g. diabetes , liver cirrhosis or thyroid disorders.
- Body dysmorphic disorder
- Patients on long term medications e.g. immunosuppressive drugs, steroids or cytotoxic drugs.
About this study
Official title: Superomedial Pedicle Versus Inferior Pedicle in Breast Reduction Surgery
The aim of this study is to evaluate Superomedial pedicle and Inferior pedicle techniques in breast reduction for Egyptian females and compare between both pedicles regarding cosmetic outcomes, possible complications, patient satisfaction and time of operation.
Read the detailed description
The female breast is one of the most attractive aesthetic areas in female anatomy. The size, shape, and symmetry of the breasts can have a dramatic effect on the women's wellbeing. Reduction mammaplasty is certainly one of the operations; plastic surgeons can significantly contribute to a woman's quality of life.
Macromastia or Breast Hypertrophy is a pathologic condition consisting of hypertrophy of the breast. It generates both physical and psychological distress, presenting a significant threat to a woman's health-related quality of life. Regarding Physical Distress Macromastia always associated with a number of musculoskeletal complications, including neck pain, back pain, headache, peripheral neuralgias, and shoulder pain. Often, women with mammary hypertrophy experience intertriginous skin maceration and other rashes, as well as infections all the result of heavy, pendulous breasts. In short, a woman's breast size can affect her attitudes, career choices, and personal life in many ways.
Ideal technique should end in a beautiful breast, which has good size with fullness in the upper part, attractive shape with adequate projection, elegant curves, and a nipple areola complex that is pleasing in shape and position. The result should last over years.
The inferior pedicle technique has been described with many variations by surgeons such as Ribeiro and Robbins with the nipple and areola being carried on a dermal pedicle, and it is probably one of the most popular breast reduction techniques currently in use in the United States. Advantages of this are well known. It is a rapid and safe technique that can be used on almost every breast size. It has been shown to be as good as or better than other techniques in the preservation of the neurovascular supply to the nipple. It is easily taught and learned.
The superomedial pedicle technique was first described by Orlando \& Gutherie as a modification of the superior pedicle technique. In this technique the nipple \& areola (NAC) is transposed on a superomedial de-epithelialized pedicle which contains a thin layer of subcutaneous tissue to protect the dermal blood supply.
- Conditions
- Breast Hypertrophy
- Being tested
- Breast reduction
- Keywords
- breast reduction, mammaplasty, breast-q, patient satisfaction, patient reported outcome measures, superomedial pedicle, inferior pedicle
- Medical subject headings
- Gigantomastia, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast reductionProcedure or surgery
breast reduction surgery for breast hypertrophy using either superomedial or inferior pedicle technique
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | participants undergoing superomedial pedicle breast reduction "Hall-Findlay technique" Receives: Procedure: Breast reduction |
| Group B | Active comparator | participants undergoing inferior pedicle breast reduction "Robbins technique" Receives: Procedure: Breast reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
evaluation of patient satisfaction pre/post-operatively using Arabic translated valid version of Breast-Q Reduction/Mastopexy Module (version 1)
Measured: 6 months
Blood loss
estimation of hemoglobin level deficit by evaluating hemoglobin level 24 hours post-operatively
Measured: 24 hours
Acute Complications
monitoring for the incidence of nipple \& areola congestion/ischemia, hematoma, seroma, infection, wound dehisence or skin flaps congestion/ischemia
Measured: 2 weeks
cosmetic outcomes
evaluation of breast symmetry, contour, projection, postoperative scars and shape of nipple \& areola using standard photographs (anteroposterior, lateral and oblique views) by twoplastic surgery experts
Measured: 6 months
Breast Measurements
- evaluation of breast vertical meridian and nipple to infra-mammary fold pre/post-operatively distance using tape measure
- evaluation of breast degree of ptosis using Regnault's classification
Measured: 6 months
Duration of the procedure
estimation of the duration of the surgery from sterilization until application of the dressing
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start1 Apr 2016
- Primary completion30 Mar 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast HypertrophyStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed El-Sayed Sharaf Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669679
- Sponsor's protocol ID
- SM Vs Inf. Pedicle in BR
- Status last verified
- Sep 2018
- First submitted
- 12 Sep 2018
- Last updated
- 14 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Antony AK. Reply: A matched cohort study of superomedial pedicle vertical scar breast reduction (100 breasts) and traditional inferior pedicle wise-pattern reduction (100 breasts): an outcomes study over 3 years. Plast Reconstr Surg. 2014 Jun;133(6):885e-887e. doi: 10.1097/PRS.0000000000000210. No abstract available.
PubMed 24867750Ramon Y, Sharony Z, Moscona RA, Ullmann Y, Peled IJ. Evaluation and comparison of aesthetic results and patient satisfaction with bilateral breast reduction using the inferior pedicle and McKissock's vertical bipedicle dermal flap techniques. Plast Reconstr Surg. 2000 Aug;106(2):289-95; discussion 295-7. doi: 10.1097/00006534-200008000-00006.
PubMed 10946926Cabral IV, da Silva Garcia E, Sobrinho RN, Pinto NLL, Juliano Y, Veiga-Filho J, Ferreira LM, Veiga DF. Use of the BREAST-Q Survey in the Prospective Evaluation of Reduction Mammaplasty Outcomes. Aesthetic Plast Surg. 2018 Apr;42(2):388-395. doi: 10.1007/s00266-017-1009-6. Epub 2017 Nov 9.
PubMed 29124379
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superomedial Pedicle Versus Inferior Pedicle in Breast Reduction Surgery
- ClinicalTrials.gov ID
- NCT03669679
- Acronym / sponsor ID
- SM Vs Inf. Pedicle in BR
- Conditions
- Breast Hypertrophy
- Keywords
- breast reduction, mammaplasty, breast-q, patient satisfaction, patient reported outcome measures, superomedial pedicle, inferior pedicle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 13 Sep 2018 (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 is to evaluate Superomedial pedicle and Inferior pedicle techniques in breast reduction for Egyptian females and compare between both pedicles regarding cosmetic outcomes, possible complications, patient satisfaction and time of operation.
Detailed description
The female breast is one of the most attractive aesthetic areas in female anatomy. The size, shape, and symmetry of the breasts can have a dramatic effect on the women's wellbeing. Reduction mammaplasty is certainly one of the operations; plastic surgeons can significantly contribute to a woman's quality of life.
Macromastia or Breast Hypertrophy is a pathologic condition consisting of hypertrophy of the breast. It generates both physical and psychological distress, presenting a significant threat to a woman's health-related quality of life. Regarding Physical Distress Macromastia always associated with a number of musculoskeletal complications, including neck pain, back pain, headache, peripheral neuralgias, and shoulder pain. Often, women with mammary hypertrophy experience intertriginous skin maceration and other rashes, as well as infections all the result of heavy, pendulous breasts. In short, a woman's breast size can affect her attitudes, career choices, and personal life in many ways.
Ideal technique should end in a beautiful breast, which has good size with fullness in the upper part, attractive shape with adequate projection, elegant curves, and a nipple areola complex that is pleasing in shape and position. The result should last over years.
The inferior pedicle technique has been described with many variations by surgeons such as Ribeiro and Robbins with the nipple and areola being carried on a dermal pedicle, and it is probably one of the most popular breast reduction techniques currently in use in the United States. Advantages of this are well known. It is a rapid and safe technique that can be used on almost every breast size. It has been shown to be as good as or better than other techniques in the preservation of the neurovascular supply to the nipple. It is easily taught and learned.
The superomedial pedicle technique was first described by Orlando \& Gutherie as a modification of the superior pedicle technique. In this technique the nipple \& areola (NAC) is transposed on a superomedial de-epithelialized pedicle which contains a thin layer of subcutaneous tissue to protect the dermal blood supply.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Breast reductionparticipants undergoing superomedial pedicle breast reduction "Hall-Findlay technique" |
| Group B | Active comparator | Procedure: Breast reductionparticipants undergoing inferior pedicle breast reduction "Robbins technique" |
Who may qualify
- Ages
- 22 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Bilateral breast hypertrophy
Key exclusion criteria (6 listed)
- Congenital breast anomalies.
- Pregnant, lactating or smoker patient.
- Previous breast reductions.
- Co-morbid diseases e.g. diabetes , liver cirrhosis or thyroid disorders.
- Body dysmorphic disorder
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 |
|---|---|---|
| Breast reductionbreast reduction surgery for breast hypertrophy using either superomedial or inferior pedicle technique | Procedure or surgery | Group A, Group B |
Primary outcome
Patient satisfaction
Time frame: 6 months
evaluation of patient satisfaction pre/post-operatively using Arabic translated valid version of Breast-Q Reduction/Mastopexy Module (version 1)
Blood loss
Time frame: 24 hours
estimation of hemoglobin level deficit by evaluating hemoglobin level 24 hours post-operatively
Acute Complications
Time frame: 2 weeks
monitoring for the incidence of nipple \& areola congestion/ischemia, hematoma, seroma, infection, wound dehisence or skin flaps congestion/ischemia
cosmetic outcomes
Time frame: 6 months
evaluation of breast symmetry, contour, projection, postoperative scars and shape of nipple \& areola using standard photographs (anteroposterior, lateral and oblique views) by twoplastic surgery experts
Breast Measurements
Time frame: 6 months
* evaluation of breast vertical meridian and nipple to infra-mammary fold pre/post-operatively distance using tape measure * evaluation of breast degree of ptosis using Regnault's classification
Duration of the procedure
Time frame: 6 hours
estimation of the duration of the surgery from sterilization until application of the dressing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
- Background: PubMed 24867750Antony AK. Reply: A matched cohort study of superomedial pedicle vertical scar breast reduction (100 breasts) and traditional inferior pedicle wise-pattern reduction (100 breasts): an outcomes study over 3 years. Plast Reconstr Surg. 2014 Jun;133(6):885e-887e. doi: 10.1097/PRS.0000000000000210. No abstract available.
- Background: PubMed 10946926Ramon Y, Sharony Z, Moscona RA, Ullmann Y, Peled IJ. Evaluation and comparison of aesthetic results and patient satisfaction with bilateral breast reduction using the inferior pedicle and McKissock's vertical bipedicle dermal flap techniques. Plast Reconstr Surg. 2000 Aug;106(2):289-95; discussion 295-7. doi: 10.1097/00006534-200008000-00006.
- Background: PubMed 29124379Cabral IV, da Silva Garcia E, Sobrinho RN, Pinto NLL, Juliano Y, Veiga-Filho J, Ferreira LM, Veiga DF. Use of the BREAST-Q Survey in the Prospective Evaluation of Reduction Mammaplasty Outcomes. Aesthetic Plast Surg. 2018 Apr;42(2):388-395. doi: 10.1007/s00266-017-1009-6. Epub 2017 Nov 9.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Breast reduction in people with Breast Hypertrophy, run by Assiut University.
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 6 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: finished, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 satisfaction (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03669679, which also lists 3 linked publications.
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 14 Sep 2018.