Breast Reshaping Following Massive Weight Loss
Condition: Breast Ptosis
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      Reliability of Chest Wall Perforator Flaps for Breast Reshaping following Massive Weight Loss
    

Detailed description: 
      • Primary objective: Evaluation of the vascularity of chest wall perforator flaps when used
      for breast auto-augmentation following massive weight loss (MWL).

        -  Secondary objectives:

      Assessing aesthetic outcome Type of Study: Prospective clinical study.

      Study Setting: Plastic, Burn and Maxillofacial Surgery Department, Ain Shams University
      Hospitals, Cairo, Egypt.

      Study Period: Two years.

      Study Population:

        1. Inclusion Criteria:

             -  Age: 18-45 years old.

             -  Weight:

                  -  Loss of 50% or greater of excess weight, following surgical or non-surgical
                     interventions (MWL).

                  -  Stable weight for at least 6 months, to achieve metabolic and nutritional
                     homeostasis and decrease the risk of surgical complications (Rubin et al.,
                     2004).

             -  Body mass index (BMI): 18.5 - 30 kg/m2.

             -  Ptotic and deflated breasts with Pittsburgh Rating Scale (PRS) score 2-3 (Song, et
                al., 2005).

             -  Patients seeking autologous augmentation or refusing implants.

             -  Patients requiring simultaneous contouring of lateral chest wall redundancy.

        2. Exclusion Criteria:

             -  Weight fluctuations in the previous 6 months.

             -  Medical co-morbidities (e.g., uncontrolled diabetes, uncontrolled hypertension,
                thyroid diseases, hormonal disturbances, cardiopulmonary diseases).

             -  Hereditary conditions that affect wound healing (e.g., Ehler Danlos Syndrome,
                Progeria).

             -  Active smokers (Smokers are required to stop smoking 1 month before surgery).

             -  Nutritional deficiencies (e.g., iron, vitamin B12, protein, folate).

             -  Previous breast surgery.

             -  Congenital breast deformity (e.g., tuberous breasts).

             -  Breast masses.

             -  Pregnant or lactating patients.

             -  PRS score 1.

      Study sample: Twenty cases were studied.

      Ethical Considerations:

      The research was conducted after the approval of the Ethical Review Committee of Ain shams
      University, Faculty of Medicine. All patients signed an informed consent for intervention
      including advantages, disadvantages, and risks of possible complications.

      Pre-operative patient evaluation:

        1. Complete history; including:

           - Previous weight, current weight, current height, and BMI.

           - Method of weight loss, time of intervention, any complications during the weight loss
           period.

           - Medical history.

           - Surgical history including wound healing complications.

           - Obstetric history.

           - Nutritional supplements.

           - Smoking.

        2. Local breast examination:

             -  Skin dimpling and intertrigo.

             -  Masses.

             -  Axillary lymph nodes.

             -  Position of nipple areola complex (NAC) and degree of ptosis (Regnault
                classification).

             -  Parenchyma (PRS score) - Skin laxity.

             -  Direct breast anthropometry (baseline measurements for comparison and to guide
                surgical intervention):

      The following measurements were assessed (as described by Quieregatto et al. in 2014) to help
      in pre-operative planning and to be compared to post-operative results.

      A. Anatomical landmarks:

      1. AAL: Anterior axillary line 2. MCP: Mid-clavicular plane 3. MHP: Mid-humeral plane 4. N:
      Nipple 5. SN: Sternal notch 6. IMF: Inframammary fold

      B. Linear measurements (using tape measure): (Ideal values described by Liu and Thomson in
      2011)

        1. SN-N (21 cm)

        2. N-IMF (8 cm)

        3. N-N (21 cm)

      3. Photographic assessment: Seven standardized digital photographs were taken with the
      following parameters: Fixed camera settings, identical background and lighting and a tape on
      the floor to ensure that patients stand in the same place and the same room (Swanson E.,
      2017).

      1. Frontal view 2. Left lateral view. 3. Right lateral view. 4. A view with 45° rotation to
      the left. 5. A view with 45° rotation to the right. 6. Left lateral view with arms up. 7.
      Right lateral view with arms up.

      4. Pre-operative mammography:

        -  To exclude pre-operative tumors, cysts, and fat necrosis.

        -  To assess pre-operative breast volume.

        -  To be compared to post-operative mammography.

           5. Pre-operative version of BREAST-Q: to compare to post-operative patient satisfaction.
           (Pusic et al., 2009). (Copy attached)

           6. Routine preoperative investigations.

      Surgical technique:

        1. Pinch test of excess tissue in the lateral chest wall (donor flap).

        2. Mapping of the perforators by hand-held Doppler probe.

        3. Mastopexy and auto-augmentation as described by Rubin and Khachi in 2008, which includes
           Wise Pattern with preservation of inferior and central pedicle, in addition to lateral
           extension to encompass the lateral chest wall skin roll.

        4. Intraoperative perforator marking: thoracodorsal artery perforator versus intercostal
           artery perforator.

        5. Flap transposition and anchoring to the chest wall by permanent sutures to the
           periosteum of the second rib for auto-augmentation and filling of the upper pole.

        6. Skin closure and surgical drains in the breast and donor site.

        7. Wound dressing and surgical bra.

        8. Post-operative follow-up: The patient will be evaluated:

             -  During the first 48 hours: for hematoma, NAC compromise and drain removal according
                to amount and color (less than 50 cc/ serous) and then discharged.

             -  At postoperative day 7, 10, 14 and 21: to detect any complications such as seroma,
                wound dehiscence, infection (redness, hotness, tenderness, discharge).

      Patient evaluation: Final results were documented at 3 and 6 months through:

        1. Direct breast anthropometry: To compare to pre-operative measurements, as well as assess
           the sustainability of the post-operative results.

        2. Mammography:

             -  To measure breast volume.

             -  For signs of fat necrosis as described by Chala et al. in 2004, which reflect
                partial or total flap loss: Oil cyst (radiolucent mass surrounded by a thin fibrous
                membrane). Fibrotic reaction (irregular spiculated density). Calcifications
                (thin-walled calcifications in oil cysts or coarse irregular calcifications with
                radiolucent areas interspersed between them).

        3. Post-operative version of BREAST-Q: to assess patient satisfaction.

        4. Photographic assessment (as before):

      The pre and post-operative photos were analyzed by three plastic surgery consultants who were
      not involved in the study, through a PowerPoint presentation. Data provided by surgeons were
      grouped under three categories: poor, good or excellent. The inter-observer concordance rate
      was statistically calculated.

      Statistical Analysis:

      Results are presented as number and percentage for qualitative data or mean and standard
      deviation for quantitative data. Two sets of quantitative data were compared using Student's
      t-test for dependent or independent means as appropriate. One-way analysis of variance
      (ANOVA) was used in comparing three sets of quantitative data. The results were considered
      statistically significant if P value was below 0.05.

      The pre- and post-operative photos were analyzed by three plastic surgery consultants who
      were not involved in the study. The rating was done using three categories, namely "poor",
      "good" and "excellent". The online Kappa calculator (http://justusrandolph.net/kappa/) was
      used for testing the inter-observer concordance (reliability) considering kappa values less
      than 0.40 are "poor," values from 0.40 to 0.75 are "intermediate to good," and values above
      0.75 are "excellent." Statistical Package: Statistical analysis was performed using computer
      software statistical package for the social science (SPSS, version 20; SPSS Inc., Chicago,
      Illinois, USA)
    

Intervention name(s): Breast auto-augmentation
Intervention type(s): Procedure
Intervention description(s): Single group assignment. All patients included were subjected to utilizing chest wall perforator flaps for breast reshaping.
Intervention model: Single Group Assignment
Intervention model description: All patients were subjected to the same intervention.
Masking: None (Open Label)
Primary purpose: Treatment