Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Female breast cancer patients who were surgically treated with mastectomy could opt for a full breast reconstruction with Autologous Fat Transfer in combination with external expansion.

Autologous Fat Transfer

Jamilla Wederfoort, MD, MSc

An Deliaert, MD, MsC

Ute Schmidbauer, MD, MsC

Chantal Mouës, MD, MsC

Andrzej Piatkowski de Grzymala, MD, MSc

A multicentre prospective cohort study will monitor the efficacy and safety of Autologous Fat Transfer (AFT) with pre-expansion. AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness. It follows the BREAST trial, the randomised controlled trial comparing AFT with implant-based reconstruction. In this study, patients all receive AFT.

AFT: Introduction of a Full Breast Reconstructive Method

Autologous Fat Transfer: Introduction of a Full Breast Reconstructive Method

Measured by the BREAST-Q questionnaire (quality of life subdivision)

The overall aesthetic result will be measured using 3D-photographs which will be assessed by a panel of independent plastisch surgeons, ex-breast cancer patients and healthy volunteers. In addition, the volume, shape and symmetry will be assessed by the patient using the BREAST-Q questionnaire (satisfaction with breasts subdivisions).

Measurement of short-term als well as mid-term complications associated with procedures as well as (serious) adverse events.

Oncological follow-up will comply to the guidelines for breast cancer and will take place by a yearly consult with the oncological surgeon (including physical examination and mammography/ultrasound/MRI) for 5 years postoperatively. All (loco)regional and distant recurrences will be recorded.

Cost-effectiveness analysis to determine the intramural and socio-economic costs associated with the breast reconstruction treatment.

ZonMw: The Netherlands Organisation for Health Research and Development

Maastricht University Medical Center

Symptoms and General Pathology

Pain

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Anesthetics

Propofol

Remifentanil

Desflurane

Hypnotics and Sedatives

Anesthetics, Intravenous

Anesthetics, General

Anesthetics, Inhalation

The patients will recieve intravenous anesthesia (propofol-remifentanyl)

Recommended dosage:

Propofol: Induction dosage 1,5-2,5 mg/kg Remifentanyl: Induction dosage 0,5-1μg/min The preservation dosage will depend from patients' body weight, body height and BMI

The patients will recieve volatile anesthesia (desflurane-remifentanyl)

Recommended dosage:

Desflurane dosage 6-7 MAC Remifentanyl: Induction dosage 0,5-1μg/min The preservation dosage will depend from patients' body weight, body height and BMI

Patients will be divided into 2 groups. The TIVA group (N = 23) will be administrated intravenous anesthesia (propofol-remifentanil), while to the DES group (N = 23) volatile anesthetics (desflurane-remifentanil)

Evangelos Konstantinou, RN, PhD

The aim of the present study is to investigate the effect of intravenous anesthetics versus the administration of volatile anesthetics on stress and pain levels during autologous fat transfer for breast reconstruction in a Day Care Center.

The sample of the study will be patients who will have Autologous Fat Transfer for Breast Reconstruction.

Patients will be divided into 2 groups. The TIVA group (N = 23) will be administrated intravenous anesthesia (propofol-remifentanil), while the DES group (N = 23) volatile anesthetics (desflurane-remifentanil).

Specifically, the TIVA group will include patients over 50 years of age with high risk of nausea / vomiting and postoperative delirium, as well as suspicion of malignant hyperthermia. Patients with cardiac and respiratory problems will be included in the DES group.

The following data will be collected in the Data Sheet: Patient Demographics (Gender, Age), Body Mass Index (Body Height- Body Weight). Simultaneously, the pain levels will be evaluated by VAS Optical Analogue Scale of VAS 0-10 in PACU, preoperatively and postoperatively, and perioperative pain levels will be assessed with CPOT scale (values 0-8).

Stress levels will be evaluated with 3 NAS questions: a. How sad do you feel right now? b. How anxious do you feel right now? and c. How optimistic do you feel right now?. The 3 NAS questions will also be given preoperatively and postoperatively to the ward. The sedation levels will be assessed by RASS scale (values +4 to -5) and the Bispectral Index (BIS). The level of patient's awareness will be assessed by GCS Scale (3 (indicating deep unconsciousness) and either 14 (original scale) or 15 (more widely used modified or revised scale)).

The presence or absence of nausea / vomiting and the appearance of immediate postoperative complications will be examined. Finally, post-operative stress will be examined with stress biomarkers, salivary ACTH hormone and salivary cortisol hormone.

TIVA Admnistration and Autologous Fat Transfer in Breast Reconstruction

TIVA Versus Volatile Anesthetics Admnistration on Stress and Pain Levels During Autologous Fat Transfer in Breast Reconstruction, in a Day Care Center

Analyzing Cortisol and Adrenocorticotropic hormones levels in salivary samples.

Analyzing Cortisol and Adrenocorticotropic hormones levels in salivary samples in patients after breast recostruction in a day care center.

These measures will occured in three phases a. preoperatively, b. perioperatively c. in the PACU phase.

Evaluating perioperative pain levels between the two protocols with scale such as Critical Care Pain Observational Tool (CPOT scale, range 0-8(with a score of 0 = None and 8 = severe pain) )

Evaluating perioperative stress levels between the two protocols with scale, such as the self-experienced questions (range0-10, (with a score of 0 = None and 10 = Completely) ) how sad are you feeling?in two phases: a. preoperatively, b) in PACU

Evaluation with Richmond Agitation-Sedation Scale (RASS scale, range +4 to -5, (with a score of -5 = unarousable and +4 = violent, immediate danger for the staff) ).

Evaluation with Bispectral index (BIS, range 0-100). A BIS score quantifies changes in the electrophysiologic state of the brain during anesthesia. In patients who are awake, a typical BIS score is 90 to 100. Complete suppression of cortical activity results in a BIS score of 0, known as a flat line. Lower numbers indicate a higher hypnotic effect. Overall, a BIS value below 60 is associated with a low probability of response to commands.

Evaluating perioperative pain levels between the two protocols with scale such as Visual analogu pain scale (VAS, range 0-10, (with a score of 0 = None and 10 = severe pain) ) in PACU

Evaluating perioperative stress levels between the two protocols with scale, such as three self-experienced questions (range0-10, (with a score of 0 = None and 10 = Completely) ) how stressed are you feeling, in two phases: a. preoperatively, b) in PACU

Evaluating perioperative stress levels between the two protocols with scale, such as three self-experienced questions (range0-10, (with a score of 0 = None and 10 = Completely) ) how optimistic are you feeling, in two phases: a. preoperatively, b) in PACU

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
AFT: Introduction of a Full Breast Reconstructive Method	NCT04261829	Breast Cancer Reconstructive ... Breast Reconstr...	Autologous Fat ...	18 Years -	Maastricht University Medical Center
TIVA Admnistration and Autologous Fat Transfer in Breast Reconstruction	NCT04077827	Breast Cancer	Propofol	20 Years - 70 Years	National and Kapodistrian University of Athens
TIVA Admnistration and Autologous Fat Transfer in Breast Reconstruction	NCT04077827	Breast Cancer	Propofol	20 Years - 70 Years	National and Kapodistrian University of Athens
AFT: Introduction of a Full Breast Reconstructive Method	NCT04261829	Breast Cancer Reconstructive ... Breast Reconstr...	Autologous Fat ...	18 Years -	Maastricht University Medical Center

Spots Global Cancer Trial Database for autologous fat transfer