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Trial record 4 of 7 for:    mátrai zoltán | Hungary

Comparison of the Cosmetic Results, Quality of Life and Patient Satisfaction Achieved With Round-block and Retroglandular Oncoplastic Breast Conserving Surgeries

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ClinicalTrials.gov Identifier: NCT04349527
Recruitment Status : Recruiting
First Posted : April 16, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Zoltan Matrai, National Institute of Oncology, Hungary

Brief Summary:

The aim of this clinical study is to analyze due long term follow-up, the clinical, oncological, aesthetic results and patients' reported quality of life and satisfaction in a responsive-adaptive (RAR) prospective, randomized study at a large number of patients whom receive round-block and retroglandular oncoplastic breast conserving surgeries.

According to the study's hypothesis, breast conserving surgery can be oncologically successful and safe with low complication rates resulting in high rate of patient satisfaction and good quality of life, which can be maintained for a long time after WBI with the application of modern oncoplastic breast conserving surgeries. We assume in this study that against of the earliest and mostly studied round-block oncoplastic surgery, the retroglandular technique, firstly reported in the literature by the current authors, is also adequate for oncologically safe, radical tumor removal that comes with low complication rates, suited for adjuvant treatments and able to offer better cosmetic results (NAC does not distorted, and pathological scar will not develop) than round-block OPS and high rate of patient's satisfaction that can be maintained for long-term.


Condition or disease Intervention/treatment
Breast Cancer Quality of Life Patient Satisfaction Procedure: Round-block Oncoplastic Breast Conserving Surgeries Procedure: Retroglandular Oncoplastic Breast Conserving Surgeries

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Study Type : Observational
Estimated Enrollment : 242 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of the Cosmetic Results, Quality of Life and Patient Satisfaction Achieved With Round-block and Retroglandular Oncoplastic Breast Conserving Surgeries. Response-adaptive (RAR) Prospective Randomised, Comperative Clinical Study
Actual Study Start Date : April 18, 2020
Estimated Primary Completion Date : April 5, 2022
Estimated Study Completion Date : April 5, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics

Group/Cohort Intervention/treatment
RB Group
In this Group Patients receive round-block oncoplastic breast coserving surgery
Procedure: Round-block Oncoplastic Breast Conserving Surgeries
We de-epithelize the gap between the double round-lines, and we dissect the dermis from the best localization where we can reach the tumor. If the tumor located close to the skin then we are not performing de-epithelization, we excise it with the skin. We mark every wall of the tumor bed with clips. We dissect the surrounding parenchyma- so called parenchyma pillars- from the pectoral fascia and the skin, and we mobilize it. The line under the skin means, the layer under the subcutis, above the superficial fascia, so gives appropriate blood supply to the skin. After this the incision line should be placed 5 mm from the outer round line, so a dermis pillar should be left, and the skin is dissected from the parenchyma as needed. The outer round line should be tightened with a non-absorbable running Benelli suture to fit the areola then interrupted sutures placed to make tensionless the running intracutaneous suture.

RG Group
In this Group Patients receive retrogladular oncoplastic breast coserving surgery
Procedure: Retroglandular Oncoplastic Breast Conserving Surgeries
We incise the skin slightly lateral in the IMF, around 7 cm long. We dissect with electrocauther the parenchyma with the pectoral fascia from the pectoralis major muscle at least until the mamilla. We incise the fascia along with the parenchyma which contains the tumor and macroscopically 10 mm safe zone. If the tumor is palpable, we turn the parenchyma slightly inside-out, if not, we localize it at the maximum measurement detected according to the ROLL labeling. After marking the tumor bed, we directly adapt the surrounding parenchyma pillars with absorbable sutures, or inverting sutures, or if it requires, we adapt the tumor bed with so-called dual plane mobilization. After revision, we close the fascia with absorbable running suture over the Redon drain then subcutaneous running suture with absorbable suture and finally intracutaneous skin closure.




Primary Outcome Measures :
  1. Oncological safety [ Time Frame: five years follow up ]
    Correlation analysis of oncological control (overall and disease free survival) achieved by various surgical techniques. The follow-up is similar to the surgical and oncological follow-up in the National Cancer Institute, so it is not a burden for the patients. The overall and disease free survival is calculated from the surgigal treatment to first event. The event such as death, local recurrence, locoregional recurrence or distant metasasis will be recorded.

  2. Cosmetic results [ Time Frame: five years follow up ]
    The primary aesthetic stage will be documented with standard photo documentation using valid BCCT.core software making it measurable which allows us to compare it. the photo documentation performed the standard way in 5 position (antero-posterior (ap), 45 degree oblique and 90 degree lateral), in ap direction both ways arms up and down with strict adherence to personal privacy policies. The mentioned software counts measurements regarding to the photo documentation and gives a 4-point rating scale (1: excellent, 2: good, 3: acceptable, 4: non-acceptable). These numerical results can be statistically analyzed. We use the Likert scale (1. definitely not, 2: no, 3: abstain, 4: agree, 4: definitely agree) for evaluating the subjective aesthetic outcome based on the photo documentation (preoperative, postoperative 4-6th weeks, 3rd months, every 6 months 5 years long). The results are collected and averaged.

  3. Patients' satisfaction [ Time Frame: five years follow up ]
    Correlation analysis of patients' satisfaction achieved by various surgical techniques. The patients' satisfaction life is measured by BREAST-Q validated questionnaire. According to this, we give a score in a 1-100 scale measuring the variables of "satisfaction with the breast", "discomfort by radiotherapy" We use preoperatively a preoperative questionnaire and postoperatively a postoperative questionnaire. Higher rates show better patients' satisfaction. The questionnaires are filled before the procedure and after the surgery 4th-6th weeks then postoperatively in the 3rd months and every 6th months.

  4. Quality of life [ Time Frame: five years follow up ]
    Correlation analysis of quality of life achieved by various surgical techniques. The quality of life is measured by BREAST-Q validated questionnaire. According to this, we give a score in a 1-100 scale measuring the variables of "psychosexual wellbeing" and "physical wellbeing". We use preoperatively a preoperative questionnaire and postoperatively a postoperative questionnaire. Higher rates show better quality of life. The questionnaires are filled before the procedure and after the surgery 4th-6th weeks then postoperatively in the 3rd months and every 6th months.


Secondary Outcome Measures :
  1. Complication's ratio [ Time Frame: 5 years follow up ]
    Postoperative complications were classified following Clavien-Dindo Classification. Grade I complication (light inflammations, non-surgical haematoma or suffusion, seroma formation, partial skin/NAC loss, limited fat necrosis, SSI and lymphoedema) does not require medication or surgical treatment. Grade II complication is a Grade I complication that requires medication or surgical interaction (antibiotic therapy, resuture due SSI and multiple puncture due chronic seroma). Grade III complication requires invasive surgical action (haematoma evacuation, chronic inflammation which requires reoperation, severe fat necrosis, full skin/ NAC necrosis and wound dehiscense). Grade IV complication means temporary organ failure. Grade V complication is one that leads to death.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The aim of the clinical study is to measure with a long-term follow-up and with qualitative and quantitative indicators the changes in cosmetic results, quality of life and patient satisfaction after delayed- immediate breast reconstruction with standardized technique Skin Reducing Nipple sparing mastectomy, SRNSM and SSM. The planned subgroups contain 50-50 cases. Planned number of patients (calculated patients' number plus 10%): 50x2=100 +10 cases

  • 110 cases should be included.
Criteria

Inclusion Criteria:

  • - Under the age of 65, suffering from unilateral (cT< 3cm) in situ or invasive breast cancer, who are fit for breast conserving surgeries, who had no previous breast surgery, independent from axillary surgery (sentinel lymph node biopsy or axillary block dissection)

Exclusion Criteria:

  • In case the patient does not volunteer for the examination or the follow-ups
  • Age above 65 years or poor general health condition, where the estimated life expectancies would be less than 2 years even without a tumor
  • Malignant invasive tumor in the past history (except for non-melanoma skin tumors)
  • Mastectomy performed due to positive resection margin
  • Prior breast surgery (e.g. aesthetic surgery, breast lift) and/or radiotherapy on the breast or in the axilla
  • Malignant tumor is not removed completely with pathological examination
  • Severe non-surgical (e.g. radiotherapy) complication, which could influence the aesthetic and functional results
  • Autoimmune diseases
  • Tumor requiring mastectomy, or clinically larger than 3 cm tumor primary, or mastitis carcinomatosa, lymphangitis carcinomatosa
  • Long-term steroid usage, which changed the skin's quality and structure
  • Patient under foster care, or psychically non-cooperative patient

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): NCT04349527


Locations
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Hungary
National Institute of Oncology Recruiting
Budapest, Hungary, 1122
Contact: Zoltan Matrai, M.D. Dr. med. habil, PhD    +3612248600 ext 3302    matraidoc@gmail.com   
Principal Investigator: Zoltan Matrai, M.D. Dr. Habil Ph.D. FEBS         
Sub-Investigator: Mihaly Ujhelyi, M.D. Ph.D. FEBS         
Sub-Investigator: Akos Savolt, M.D. Ph.D. FEBS         
Sub-Investigator: Peter Kelemen, M.D. FEBS         
Sub-Investigator: Orsolya Huszár, M.D.         
Sub-Investigator: Orsolya Ping, M.D.         
Sub-Investigator: Szilard Domjan, M.D.         
Sub-Investigator: István Kenessey, M.D. Ph.D.         
Sub-Investigator: Eszter Kovács, M.D.         
Sub-Investigator: Gabor Rubovszky, M.D. Ph.D.         
Sub-Investigator: Norbert Meszaros, M.D.         
Sponsors and Collaborators
National Institute of Oncology, Hungary
Publications:
Mátrai Z GG, Kovács T, Kásler M Principles and practice of oncoplastic breast surgery. Medicina Kiadó; 2019.

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Responsible Party: Dr. Zoltan Matrai, Head of Surgical Oncology, National Institute of Oncology, Hungary
ClinicalTrials.gov Identifier: NCT04349527    
Other Study ID Numbers: RB-vs-RG-BCS
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No