Mastopexy With Autologous Augmentation in Women After Massive Weight Loss - A Clinical, Randomized Study
NCT ID: NCT02572271
Last Updated: 2018-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2015-09-30
2017-11-16
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rubins Mastopexy
Patients are allocated to a mastopexy using Rubins technique
Rubins Mastopexy
The surgical technique described by Rubin is performed. No other intervention.
LOPOSAM
Patients are allocated to a mastopexy using the LOPOSAM technique
LOPOSAM
The surgical technique LOPOSAM is performed. No other intervention.
Interventions
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Rubins Mastopexy
The surgical technique described by Rubin is performed. No other intervention.
LOPOSAM
The surgical technique LOPOSAM is performed. No other intervention.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Non-Danish speaking
FEMALE
No
Sponsors
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Odense University Hospital
OTHER
Responsible Party
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Peder Ikander
MD
Principal Investigators
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Peder Ikander, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Plastic and Reconstructive Surgery, Odense University Hospital, Odense, Denmark
Locations
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Odense University Hospital, Department of Plastic and Reconstructive Surgery
Odense C, , Denmark
Countries
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References
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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.
Rubin 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.
Gusenoff 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.
Rubin 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.
Thoma 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.
Hansson 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.
Pusic 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.
Fischer 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.
Cardoso 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.
Godwin 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.
Related Links
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The Danish National Board of Health criteria for post bariatric surgery
Other Identifiers
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S-20150106CKH/bss
Identifier Type: -
Identifier Source: org_study_id
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