Actively Recruiting

Age: 18Years - 65Years
FEMALE
Healthy Volunteers
ID04349527

Comparison of Cosmetic Results, Quality of Life, and Patient Satisfaction With Round-block and Retroglandular Oncoplastic Breast Conserving Surgeries Response-adaptive Prospective Randomized Clinical Study

Led by National Institute of Oncology, Hungary · Updated on 2020-04-21

242

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the clinical, oncological, and aesthetic outcomes and patients' quality of life and satisfaction following two types of oncoplastic breast conserving surgeries in women with early unilateral breast cancer. This responsive-adaptive prospective randomized study compares the widely studied round-block technique with the newer retroglandular technique, hypothesizing both provide safe tumor removal with low complication rates, good cosmetic results, and sustained patient satisfaction after whole breast irradiation. Participants receive either round-block or retroglandular oncoplastic breast conserving surgery, both standardized surgical procedures adapted to tumor location and breast anatomy. The round-block method involves de-epithelizing and mobilizing breast tissue near the tumor, while the retroglandular technique includes dissecting tissue beneath the breast and muscle. After surgery, patients undergo standard oncological treatments, and follow-up includes regular assessments over five years. Participants undergo preoperative examinations including biopsies, imaging, and breast measurements, with data collected on tumor characteristics and patient health. Postoperative follow-up occurs at 4-6 weeks, 3 months, and then every 6 months for 5 years, involving photo documentation, breast measurements, software analysis, and quality of life questionnaires. Researchers monitor oncological safety, cosmetic outcomes, patient satisfaction, complications, and quality of life throughout the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female, aged 18 to 65 years
  • Diagnosed with unilateral in situ or invasive breast cancer smaller than 3 cm
  • Fit for breast conserving surgery
  • No previous breast surgery
  • Eligible regardless of axillary surgery type (sentinel lymph node biopsy or axillary block dissection)
Not Eligible

You will not qualify if you...

  • Not volunteering for the examinations or follow-ups
  • Age over 65 or poor general health with life expectancy less than 2 years without tumor
  • History of malignant invasive tumors except non-melanoma skin tumors
  • Mastectomy performed due to positive resection margin
  • Prior breast surgery (including aesthetic or breast lift) or radiotherapy on breast or axilla
  • Incomplete tumor removal confirmed pathologically
  • Severe non-surgical complications affecting aesthetic or functional results
  • Autoimmune diseases
  • Tumor requiring mastectomy, tumor larger than 3 cm, mastitis carcinomatosa, or lymphangitis carcinomatosa
  • Long-term steroid use affecting skin quality and structure
  • Patient in foster care or psychically uncooperative patient

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - 1 day

Participants undergo either round-block or retroglandular oncoplastic breast conserving surgery as part of their treatment.

1 surgical procedure (in-person)

Post-operative Follow-up

Duration - Up to 5 years

Participants attend follow-up visits for photo documentation, body measurements, and quality of life assessments to monitor cosmetic results, satisfaction, and health status.

Visits at 4-6 weeks, 3 months, then every 6 months up to 5 years

Trial Site Locations

Total: 1 location

1

National Institute of Oncology

Budapest, Hungary, 1122

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer.

Bernard Fisher, Stewart Anderson, John Bryant...

https://pubmed.ncbi.nlm.nih.gov/12393820

Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer.

Umberto Veronesi, Natale Cascinelli, Luigi Mariani...

https://pubmed.ncbi.nlm.nih.gov/12393819

Objective decision making between conventional and oncoplastic breast-conserving surgery or mastectomy: An aesthetic and functional prospective cohort study.

D Pukancsik, P Kelemen, M Újhelyi...

https://pubmed.ncbi.nlm.nih.gov/28069398

Evaluation of a Retroglandular Oncoplastic Technique as a Standard Level I Oncoplastic Breast-Conserving Surgery: A Retrospective Clinicopathologic Study of 102 Patients With Breast Cancer.

Zoltán Mátrai, Mihály Újhelyi, Tibor Kovács...

https://pubmed.ncbi.nlm.nih.gov/30992191