Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02572271
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Peder Ikander, Odense University Hospital

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.

Condition or disease Intervention/treatment Phase
Weight Loss Procedure: Rubins Mastopexy Procedure: LOPOSAM Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Procedure: LOPOSAM
The surgical technique LOPOSAM is performed. No other intervention.




Primary Outcome Measures :
  1. Operation Time [ Time Frame: Intraoperative ]
    The time of surgery from start to finish is registered for both techniques.


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Denmark
Odense University Hospital, Department of Plastic and Reconstructive Surgery
Odense C, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Peder Ikander, MD Department of Plastic and Reconstructive Surgery, Odense University Hospital, Odense, Denmark
Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Peder Ikander, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02572271    
Other Study ID Numbers: S-20150106CKH/bss
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Peder Ikander, Odense University Hospital:
Autologous augmentation
Mastopexy
Massive weight loss
Additional relevant MeSH terms:
Layout table for MeSH terms
Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes