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Completed

NCT Number: NCT02572271

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

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Key information

Conditions

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

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital, Department of Plastic and Reconstructive Surgery

Odense C, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rubins Mastopexy

Procedure

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

LOPOSAM

Procedure

The surgical technique LOPOSAM is performed. No other intervention.

Primary outcomes

  1. Operation Time

    Time frame: Intraoperative

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

Secondary outcomes

  1. Costs of treatment

    Time frame: 1 year

    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

  2. Breast measurements

    Time frame: 1 year

    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

  3. Cosmetic result

    Time frame: 1 year

    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

  4. Complications

    Time frame: 3 months

    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

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 8, 2015
Registry last updated
Aug 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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