Weight LossNCT02572271
Mastopexy With Autologous Augmentation in Women After Massive Weight Loss - A Clinical, Randomized Study
A study testing Rubins Mastopexy and LOPOSAM in people with Weight Loss, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to compare two different techniques of mastopexy with autologous augmentation, the Lower Pole Subglandular Advancement Mastoplasty (LOPOSAM) and Rubins Mastopexy with autologous augmentation, in massive weight loss patients to see if one technique is superior to the other. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Weight Loss
- What is being tested?
- Rubins Mastopexy and LOPOSAM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2015to 16 Nov 2017
- 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
- Women that meet the Danish National Board of Health criteria for post bariatric surgery, and is found to be a suitable candidate for autologous augmentation
Who cannot join
- Severe dementia, making informed consent impossible
- Non-Danish speaking
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Odense University Hospital, Department of Plastic and Reconstructive Surgery
Odense C, 5000
About this study
The purpose of this study is to compare two different techniques of mastopexy with autologous augmentation, the Lower Pole Subglandular Advancement Mastoplasty (LOPOSAM) and Rubins Mastopexy with autologous augmentation, in massive weight loss patients to see if one technique is superior to the other.
Read the detailed description
In Massive Weight Loss (MWL) patients the breasts often appear deflated following the prominent volume decrease. The breast is not only deflated, the supportive fibrous tissue is lax and the structural properties have changed. In the typical patient the breast base has sunk along with the inframammary crease and the shape of the breast is wide and flat with a significant ptosis.
One way of helping these women is to offer a mastopexy with autologous augmentation. There are several different surgical techniques for treating the ptotic and deflated breast in MWL patients.
In this study the investigators compare the investigators own technique, LOPOSAM, with Rubins Mastopexy with autologous augmentation.
In Rubins Mastopexy, an extensive re-arrangement of the skin, fat and breast tissue is done and this is supposed to give good long term results. The procedure is however time consuming and extensive.
The LOPOSAM technique is less extensive and therefore less time consuming and the investigators hypothesis is therefore that the technique has a lower complication rate.
Women that is referred for mastopexy after MWL and meet the criteria for post bariatric surgery, set by the Danish National Board of Health, and is found to be a suitable candidate for mastopexy with autologous augmentation is invited to participate in the study.
Sample size assessment has shown that 22 women (11 in each group) is needed and this number of patients is expected to be recruited in 6-9 months.
The study design is a prospective randomized trial.
Preoperative breast measurements and clinical photographs will be compared with measurements and clinical photographs at 3, 6 and 12 months postoperative
The primary outcome is operation time but secondary outcomes include economics, breast measurements, cosmetic result and complication rates.
With this trial, the investigators hope to demonstrate whether or not one of the two techniques is superior to the other and therefore should be the preferred technique.
- Conditions
- Weight Loss
- Being tested
- Rubins Mastopexy, LOPOSAM
- Keywords
- Autologous augmentation, Mastopexy, Massive weight loss
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rubins MastopexyProcedure or surgery
The surgical technique described by Rubin is performed. No other intervention.
LOPOSAMProcedure or surgery
The surgical technique LOPOSAM is performed. No other intervention.
| Study group | Role | What they receive |
|---|---|---|
| Rubins Mastopexy | Active comparator | Patients are allocated to a mastopexy using Rubins technique Receives: Procedure: Rubins Mastopexy |
| LOPOSAM | Active comparator | Patients are allocated to a mastopexy using the LOPOSAM technique Receives: Procedure: LOPOSAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation Time
The time of surgery from start to finish is registered for both techniques.
Measured: Intraoperative
Secondary outcomes (4)
Costs of treatment
In order to evaluate the socio-economic aspects and cost-benefit associated with the use of each surgical technique we record the following parameters for all patients: Duration of operation, duration of hospitalization, duration of entire course of the breast reconstruction, duration of sick leave and need for revisional/correctional procedures. With these data we can evaluate which technique is the most cost beneficial
Measured: 1 year
Breast measurements
Standardized breast measurements preoperative and at 3, 6 and 12 months postoperative is registered. Measurements registered include sternal notch to nipple distance, breast base and height, projection of the breast and ptosis of the breast, measured with a tape measure.
From this data the investigators can evaluate the long lasting effect of the different techniques
Measured: 1 year
Cosmetic result
The cosmetic result will be evaluated both by the patient on a scale from 1-10 at 3, 6 and 12 months postoperative and by external senior plastic surgeons by evaluating clinical photographs
Measured: 1 year
Complications
Difference in complications between the two techniques will be registered during the follow-up period.They will include: wound dehiscence, partial necrosis, infection and haematoma. Complications will be classified as either major or minor depending on the need for surgical revision
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startSep 2015
- Primary completion16 Nov 2017
- Study completion16 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peder Ikander, Odense University Hospital
- Investigators
- Peder Ikander, MD, Principal investigator, Department of Plastic and Reconstructive Surgery, Odense University Hospital, Odense, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572271
- Sponsor's protocol ID
- S-20150106CKH/bss
- Status last verified
- Aug 2018
- First submitted
- 3 Oct 2015
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Rubin JP. Mastopexy after massive weight loss: dermal suspension and total parenchymal reshaping. Aesthet Surg J. 2006 Mar-Apr;26(2):214-22. doi: 10.1016/j.asj.2006.01.010.
PubMed 19338902Rubin JP, Khachi G. Mastopexy after massive weight loss: dermal suspension and selective auto-augmentation. Clin Plast Surg. 2008 Jan;35(1):123-9. doi: 10.1016/j.cps.2007.08.008.
PubMed 18061806Gusenoff JA, Rubin JP. Plastic surgery after weight loss: current concepts in massive weight loss surgery. Aesthet Surg J. 2008 Jul-Aug;28(4):452-5. doi: 10.1016/j.asj.2008.06.001.
PubMed 19083561Rubin JP, Gusenoff JA, Coon D. Dermal suspension and parenchymal reshaping mastopexy after massive weight loss: statistical analysis with concomitant procedures from a prospective registry. Plast Reconstr Surg. 2009 Mar;123(3):782-789. doi: 10.1097/PRS.0b013e31819ba1a8.
PubMed 19319040Thoma A, Kaur MN, Tsoi B, Ziolkowski N, Duku E, Goldsmith CH. Cost-effectiveness analysis parallel to a randomized controlled trial comparing vertical scar reduction and inverted T-shaped reduction mammaplasty. Plast Reconstr Surg. 2014 Dec;134(6):1093-1107. doi: 10.1097/PRS.0000000000000751.
PubMed 25255113Hansson E, Manjer J, Ringberg A. Inter-observer reliability of clinical measurement of suprasternal notch-nipple distance and breast ptosis. Indian J Plast Surg. 2014 Jan;47(1):61-4. doi: 10.4103/0970-0358.129625.
PubMed 24987206Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807.
PubMed 19644246Fischer JP, Cleveland EC, Shang EK, Nelson JA, Serletti JM. Complications following reduction mammaplasty: a review of 3538 cases from the 2005-2010 NSQIP data sets. Aesthet Surg J. 2014 Jan 1;34(1):66-73. doi: 10.1177/1090820X13515676. Epub 2013 Dec 13.
PubMed 24334499Cardoso MJ, Cardoso JS, Wild T, Krois W, Fitzal F. Comparing two objective methods for the aesthetic evaluation of breast cancer conservative treatment. Breast Cancer Res Treat. 2009 Jul;116(1):149-52. doi: 10.1007/s10549-008-0173-4. Epub 2008 Sep 7.
PubMed 18777134Godwin Y, Barron EJ, Edmunds MC, Meyer M, Bardsley A, Logan AM, O'Neill TJ, Wood SH. A comparison of the patient and surgeon opinion on the long-term aesthetic outcome of reduction mammaplasty: have we improved over 15 years? J Plast Reconstr Aesthet Surg. 2014 Jul;67(7):932-8. doi: 10.1016/j.bjps.2014.04.006. Epub 2014 May 9.
PubMed 24860932
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mastopexy With Autologous Augmentation in Women After Massive Weight Loss - A Clinical, Randomized Study
- ClinicalTrials.gov ID
- NCT02572271
- Acronym / sponsor ID
- S-20150106CKH/bss
- Conditions
- Weight Loss
- Keywords
- Autologous augmentation, Mastopexy, Massive weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- 16 Nov 2017 (actual)
- Study completion
- 16 Nov 2017 (actual)
- First posted
- 8 Oct 2015 (estimated)
- 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 purpose of this study is to compare two different techniques of mastopexy with autologous augmentation, the Lower Pole Subglandular Advancement Mastoplasty (LOPOSAM) and Rubins Mastopexy with autologous augmentation, in massive weight loss patients to see if one technique is superior to the other.
Detailed description
In Massive Weight Loss (MWL) patients the breasts often appear deflated following the prominent volume decrease. The breast is not only deflated, the supportive fibrous tissue is lax and the structural properties have changed. In the typical patient the breast base has sunk along with the inframammary crease and the shape of the breast is wide and flat with a significant ptosis.
One way of helping these women is to offer a mastopexy with autologous augmentation. There are several different surgical techniques for treating the ptotic and deflated breast in MWL patients.
In this study the investigators compare the investigators own technique, LOPOSAM, with Rubins Mastopexy with autologous augmentation.
In Rubins Mastopexy, an extensive re-arrangement of the skin, fat and breast tissue is done and this is supposed to give good long term results. The procedure is however time consuming and extensive.
The LOPOSAM technique is less extensive and therefore less time consuming and the investigators hypothesis is therefore that the technique has a lower complication rate.
Women that is referred for mastopexy after MWL and meet the criteria for post bariatric surgery, set by the Danish National Board of Health, and is found to be a suitable candidate for mastopexy with autologous augmentation is invited to participate in the study.
Sample size assessment has shown that 22 women (11 in each group) is needed and this number of patients is expected to be recruited in 6-9 months.
The study design is a prospective randomized trial.
Preoperative breast measurements and clinical photographs will be compared with measurements and clinical photographs at 3, 6 and 12 months postoperative
The primary outcome is operation time but secondary outcomes include economics, breast measurements, cosmetic result and complication rates.
With this trial, the investigators hope to demonstrate whether or not one of the two techniques is superior to the other and therefore should be the preferred technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rubins Mastopexy | Active comparator | Procedure: Rubins MastopexyPatients are allocated to a mastopexy using Rubins technique |
| LOPOSAM | Active comparator | Procedure: LOPOSAMPatients are allocated to a mastopexy using the LOPOSAM technique |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women that meet the Danish National Board of Health criteria for post bariatric surgery, and is found to be a suitable candidate for autologous augmentation
Key exclusion criteria (2 listed)
- Severe dementia, making informed consent impossible
- Non-Danish speaking
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 |
|---|---|---|
| Rubins MastopexyThe surgical technique described by Rubin is performed. No other intervention. | Procedure or surgery | Rubins Mastopexy |
| LOPOSAMThe surgical technique LOPOSAM is performed. No other intervention. | Procedure or surgery | LOPOSAM |
Primary outcome
Operation Time
Time frame: Intraoperative
The time of surgery from start to finish is registered for both techniques.
4 secondary outcomes
Costs of treatment
Time frame: 1 year
Breast measurements
Time frame: 1 year
Cosmetic result
Time frame: 1 year
Complications
Time frame: 3 months
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 22 Aug 2018.
- Background: PubMed 19338902Rubin JP. Mastopexy after massive weight loss: dermal suspension and total parenchymal reshaping. Aesthet Surg J. 2006 Mar-Apr;26(2):214-22. doi: 10.1016/j.asj.2006.01.010.
- Background: PubMed 18061806Rubin JP, Khachi G. Mastopexy after massive weight loss: dermal suspension and selective auto-augmentation. Clin Plast Surg. 2008 Jan;35(1):123-9. doi: 10.1016/j.cps.2007.08.008.
- Background: PubMed 19083561Gusenoff JA, Rubin JP. Plastic surgery after weight loss: current concepts in massive weight loss surgery. Aesthet Surg J. 2008 Jul-Aug;28(4):452-5. doi: 10.1016/j.asj.2008.06.001.
- Background: PubMed 19319040Rubin JP, Gusenoff JA, Coon D. Dermal suspension and parenchymal reshaping mastopexy after massive weight loss: statistical analysis with concomitant procedures from a prospective registry. Plast Reconstr Surg. 2009 Mar;123(3):782-789. doi: 10.1097/PRS.0b013e31819ba1a8.
- Background: PubMed 25255113Thoma A, Kaur MN, Tsoi B, Ziolkowski N, Duku E, Goldsmith CH. Cost-effectiveness analysis parallel to a randomized controlled trial comparing vertical scar reduction and inverted T-shaped reduction mammaplasty. Plast Reconstr Surg. 2014 Dec;134(6):1093-1107. doi: 10.1097/PRS.0000000000000751.
- Background: PubMed 24987206Hansson E, Manjer J, Ringberg A. Inter-observer reliability of clinical measurement of suprasternal notch-nipple distance and breast ptosis. Indian J Plast Surg. 2014 Jan;47(1):61-4. doi: 10.4103/0970-0358.129625.
- Background: PubMed 19644246Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807.
- Background: PubMed 24334499Fischer JP, Cleveland EC, Shang EK, Nelson JA, Serletti JM. Complications following reduction mammaplasty: a review of 3538 cases from the 2005-2010 NSQIP data sets. Aesthet Surg J. 2014 Jan 1;34(1):66-73. doi: 10.1177/1090820X13515676. Epub 2013 Dec 13.
- Background: PubMed 18777134Cardoso MJ, Cardoso JS, Wild T, Krois W, Fitzal F. Comparing two objective methods for the aesthetic evaluation of breast cancer conservative treatment. Breast Cancer Res Treat. 2009 Jul;116(1):149-52. doi: 10.1007/s10549-008-0173-4. Epub 2008 Sep 7.
- Background: PubMed 24860932Godwin Y, Barron EJ, Edmunds MC, Meyer M, Bardsley A, Logan AM, O'Neill TJ, Wood SH. A comparison of the patient and surgeon opinion on the long-term aesthetic outcome of reduction mammaplasty: have we improved over 15 years? J Plast Reconstr Aesthet Surg. 2014 Jul;67(7):932-8. doi: 10.1016/j.bjps.2014.04.006. Epub 2014 May 9.
- The Danish National Board of Health criteria for post bariatric surgeryLink provided by the sponsor.
- 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.
Peder Ikander, MD principal investigator
Department of Plastic and Reconstructive Surgery, Odense University Hospital, Odense, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rubins Mastopexy and LOPOSAM in people with Weight Loss, run by Odense University Hospital at 1 site in Denmark.
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 2 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 22 Aug 2018. 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 Denmark. 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?
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?
Operation Time (time frame: Intraoperative). 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 NCT02572271, which also lists 10 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 22 Aug 2018; AzTrials last refreshed its copy on 8 Nov 2026.