Clinical trial NCT02572271: Mastopexy With Autologous Augmentation in Women After Massive Weight Loss - A Clinical, Randomized Study
Official title: Mastopexy With Autologous Augmentation in Women After Massive Weight Loss - A Clinical, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Keywords: Autologous augmentation
Mastopexy
Massive weight loss
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2015-10-08
Enrollment: 22
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Operation Time
timeFrame: Intraoperative
Secondary outcomes:
measure: Costs of treatment
timeFrame: 1 year
measure: Breast measurements
timeFrame: 1 year
measure: Cosmetic result
timeFrame: 1 year
measure: Complications
timeFrame: 3 months
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Odense University Hospital, Department of Plastic and Reconstructive Surgery
Study officials:
affiliation: Department of Plastic and Reconstructive Surgery, Odense University Hospital, Odense, Denmark
name: Peder Ikander, MD
role: PRINCIPAL_INVESTIGATOR
References:
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