Mastopexy With Autologous Augmentation in Women After Massive Weight Loss - A Clinical, Randomized Study
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|ClinicalTrials.gov Identifier: NCT02572271|
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : August 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Weight Loss||Procedure: Rubins Mastopexy Procedure: LOPOSAM||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mastopexy With Autologous Augmentation in Women After Massive Weight Loss - A Clinical, Randomized Study|
|Actual Study Start Date :||September 2015|
|Actual Primary Completion Date :||November 16, 2017|
|Actual Study Completion Date :||November 16, 2017|
Active Comparator: Rubins Mastopexy
Patients are allocated to a mastopexy using Rubins technique
Procedure: Rubins Mastopexy
The surgical technique described by Rubin is performed. No other intervention.
Active Comparator: LOPOSAM
Patients are allocated to a mastopexy using the LOPOSAM technique
The surgical technique LOPOSAM is performed. No other intervention.
- Operation Time [ Time Frame: Intraoperative ]The time of surgery from start to finish is registered for both techniques.
- 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
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572271
|Odense University Hospital, Department of Plastic and Reconstructive Surgery|
|Odense C, Denmark, 5000|
|Principal Investigator:||Peder Ikander, MD||Department of Plastic and Reconstructive Surgery, Odense University Hospital, Odense, Denmark|