An interventional study of Rubins Mastopexy and LOPOSAM in Weight Loss, sponsored by Odense University Hospital. Completed at 1 site in Denmark. Open to female participants. Per ClinicalTrials.gov, last updated 2018-08-22.
Sponsored by Odense University Hospital · Not applicable, Interventional, and Treatment
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.
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.
1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.
This study's enrollment of 22 is below the median of 64 across 947 interventional studies indexed under Body Weight.
Browse Body Weight studies →Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients are allocated to a mastopexy using Rubins technique
Procedure: Rubins Mastopexy
Patients are allocated to a mastopexy using the LOPOSAM technique
Procedure: LOPOSAM
The surgical technique described by Rubin is performed. No other intervention.
The surgical technique LOPOSAM is performed. No other intervention.
Operation Time
The time of surgery from start to finish is registered for both techniques.
Time frame: Intraoperative
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 months
Plan to share: No
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Odense University Hospital