Mastopexy With Autologous Augmentation in Women After Massive Weight Loss - A Clinical, Randomized Study

NCT02572271 | Completed DMC

• 1 other identifier: S-20150106CKH/bss
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Weight Loss

Keywords

Autologous augmentation; Mastopexy; Massive weight loss

Outcome Measures

Primary Outcomes (1)

• Operation Time

  The time of surgery from start to finish is registered for both techniques.

  Intraoperative

Secondary Outcomes (4)

• Costs of treatment

  1 year

• Breast measurements

  1 year

• Cosmetic result

  1 year

• Complications

  3 months

Study Arms (2)

Rubins Mastopexy

ACTIVE COMPARATOR

Patients are allocated to a mastopexy using Rubins technique

Procedure: Rubins Mastopexy

LOPOSAM

ACTIVE COMPARATOR

Patients are allocated to a mastopexy using the LOPOSAM technique

Procedure: LOPOSAM

Interventions

Rubins Mastopexy PROCEDURE

The surgical technique described by Rubin is performed. No other intervention.

Rubins Mastopexy

LOPOSAM PROCEDURE

The surgical technique LOPOSAM is performed. No other intervention.

LOPOSAM

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe dementia, making informed consent impossible
• Non-Danish speaking

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital, Department of Plastic and Reconstructive Surgery

Odense C, 5000, Denmark

Location

Related Publications (10)

• 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.

  PMID: 19338902 BACKGROUND

• 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.

  PMID: 18061806 BACKGROUND

• 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.

  PMID: 19083561 BACKGROUND

• 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.

  PMID: 19319040 BACKGROUND

• 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.

  PMID: 25255113 BACKGROUND

• 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.

  PMID: 24987206 BACKGROUND

• 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.

  PMID: 19644246 BACKGROUND

• 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.

  PMID: 24334499 BACKGROUND

• 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.

  PMID: 18777134 BACKGROUND

• 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.

  PMID: 24860932 BACKGROUND

Related Links

• The Danish National Board of Health criteria for post bariatric surgery

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Peder Ikander, MD

  Department of Plastic and Reconstructive Surgery, Odense University Hospital, Odense, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 3, 2015
• First Posted: October 8, 2015
• Study Start: September 1, 2015
• Primary Completion: November 16, 2017
• Study Completion: November 16, 2017
• Last Updated: August 22, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)