Examining and Comparing the Temporal Changes and Results of Cosmetic, Quality of Life and Patient Satisfaction Achieved With Immediate and Delayed-immediate Implant-based Breast Reconstruction Procedures and Contralateral Symmetrization Techniques

NCT04356235 | Recruiting

• 1 other identifier: Ageing-NIO
• Study Type: observational
• Target: 528
• Locations: 1 country
• Sites: 1

Brief Summary

This is a response-adaptive (RAR) prospective randomized study with a long-term follow-up and the aim of this clinical study is to measure with qualitative and quantitative indicators the changes in cosmetic results, quality of life and patient satisfaction after breast reconstructive surgery with silicone implant (following SSM, ASM or NSM mastectomy) and symmetrization (mastopexy and/or silicone implant and/or Ultrapro mesh sling technique) over time. According to the hypothesis of the study, the results of implant-based breast reconstruction and symmetrization following advanced postmastectomy techniques significantly decrease over time and later results limited patient satisfaction rate. This is mainly due to the fact that over time, the natural breast differs from the reconstructed breast with silicone implant. Because of the different biological properties (gravity results ptosis on breast with mastopexy, significant volume increasement of the breast with mastopexy due to endocrine therapy, gradually progressive capsular contracture on the tumorous side, nipple flattening, nipple tattoo fading etc.) the two sides change differently resulting in significant asymmetry and consequently could lead to decreased patient satisfaction. The high degree of asymmetry over time (which can be similar to the difference between the result of a simple mastectomy and natural breast (control group)), may indicates additional surgeries or usage of medical devices, putting a financial burden on the patient and the health system. On the other hand, the symmetry can be achieved with bilateral skin-sparing mastectomies and implant-based immediate or delayed-immediate reconstructions is clearly better and change less with time. The mastectomy of the contralateral disease-free side is considered as an unreasonable burden for moderate risk patients. The information such as the need for multiple surgeries, change in symmetry over time etc., should be an important part of the professional decision-making mechanism and the surgeon should inform the patient during the primer surgery. Nowadays due to the lack of evidence-based knowledge, it is not part of the patient's information and surgical planning internationally. Planning breast units, attention, capacity and financial resources must also be provided to meet the long-term needs of patients who underwent postmastectomy breast reconstruction. Simple mastectomy with an external prosthesis can be an alternative for patients with intolerable degree of asymmetry or on the contrary, the results may justify the need for bilateral mastectomy and reconstruction even in the absence of high oncological risk and for purely symmetrical and cosmetic reasons.

Conditions

Mastectomy; Lymphedema; Breast Cancer; Quality of Life

Outcome Measures

Primary Outcomes (2)

• Quality of life: BREAST-Q validated questionnaire

  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

  up to 5 years

• Patient satisfaction: BREAST-Q validated questionnaire

  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.

  up to 5 years

Secondary Outcomes (1)

• Objective cosmetic results

  up to 5 years

Study Arms (6)

A:Exp-impl-mastopexy

expander-silicone implant exchange and contralateral symmetrization with mastopexy and if needed with volume reduction

Procedure: A: expander-silicone implant exchange and contralateral symmetrization with mastopexy and if needed with volume reduction

B: exp-impl-mastopexy+mesh

expander-silicone implant exchange with contralateral symmetrization with mastopexy and Ultrapro sling

Procedure: B: expander-silicone implant exchange with contralateral symmetrization with mastopexy and Ultrapro sling

C: exp-impl-mastopexy+implant

expander-silicone implant exchange and contralateral symmetrization with mastopexy and silicone implant augmentation

Procedure: C: expander-silicone implant exchange and contralateral symmetrization with mastopexy and silicone implant augmentation

D: exp-impl-mastopexy+implant+mesh

expander-silicone implant exchange and contralateral symmetrization with mastopexy and Utrapro sling and silicone implant augmentation

Procedure: D: expander-silicone implant exchange and contralateral symmetrization with mastopexy and Utrapro sling and silicone implant augmentation

E: simple masectomy

unilateral simple mastectomy

Procedure: E: unilateral simple mastectomy

F: bilateral exp-impl

after bilateral SSM, ASM, NSM, expander-implant exchange

Procedure: F: after bilateral SSM, ASM, NSM, expander-implant exchange

Interventions

A: expander-silicone implant exchange and contralateral symmetrization with mastopexy and if needed with volume reduction PROCEDURE

expander-silicone implant exchange and contralateral symmetrization with mastopexy and if needed with volume reduction

A:Exp-impl-mastopexy

B: expander-silicone implant exchange with contralateral symmetrization with mastopexy and Ultrapro sling PROCEDURE

expander-silicone implant exchange with contralateral symmetrization with mastopexy and Ultrapro sling

B: exp-impl-mastopexy+mesh

C: expander-silicone implant exchange and contralateral symmetrization with mastopexy and silicone implant augmentation PROCEDURE

expander-silicone implant exchange and contralateral symmetrization with mastopexy and silicone implant augmentation

C: exp-impl-mastopexy+implant

D: expander-silicone implant exchange and contralateral symmetrization with mastopexy and Utrapro sling and silicone implant augmentation PROCEDURE

expander-silicone implant exchange and contralateral symmetrization with mastopexy and Utrapro sling and silicone implant augmentation

D: exp-impl-mastopexy+implant+mesh

E: unilateral simple mastectomy PROCEDURE

unilateral simple mastectomy

E: simple masectomy

F: after bilateral SSM, ASM, NSM, expander-implant exchange PROCEDURE

after bilateral SSM, ASM, NSM, expander-implant exchange

F: bilateral exp-impl

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The aim of the study is to evaluate the time related cosmetic results in the subgroups of implant based postmastectomy reconstruction: mastopexy, mastopexy with Ultrapro sling technique, mastopexy with silicone implant and mastopexy with silicone implant and Ultrapro sling technique. The planned subgroups contain of 80-80 cases and the control group contains also 80 cases. Planned number of the patients (calculated patients number plus 10%): 80x6=480+ 48 cases ∑528 cases should be included.

You may qualify if:

• Under the age of 65 with uni- or bilateral primary breast cancer ( clinical Stage 0-III), needing modern skin sparing mastectomy, nipple sparing mastectomy or areola sparing mastectomy independently of the axillary surgery, having immediate or delayed-immediate implant based reconstrucion on the ipsilateral side and symmetrisation on the contralateral side ( mastopexy and/or implant based reconstruction and/or breast sling with ultrapro mesh)
• Control group: patients under 65 years with unilateral simplex mastectomy without breast reconstruction

You may not qualify if:

• 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 the tumorous disease
• Malignant invasive tumor in the past history (except for non-melanoma skin tumors)
• Mastectomyand reconstruction performed due pregnancy associated breast cancer
• Prior breast surgery (e.g. aesthetic surgery, mastopexy) 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
• Mastitis carcinomatosa
• Lymphangitis carcinomatosa
• Open wound therapy due SSI
• Long-term steroid usage, which changed the skin's quality and structure
• Patient under foster care, or psychically non-cooperative patient
• If breast correction performed during the 5 years follow up

Sponsors & Collaborators

• National Institute of Oncology, Hungary: lead

Study Sites (1)

National Institute of Oncology

Budapest, 1122, Hungary

RECRUITING

Related Publications (14)

• Galimberti V, Vicini E, Corso G, Morigi C, Fontana S, Sacchini V, Veronesi P. Nipple-sparing and skin-sparing mastectomy: Review of aims, oncological safety and contraindications. Breast. 2017 Aug;34 Suppl 1(Suppl 1):S82-S84. doi: 10.1016/j.breast.2017.06.034. Epub 2017 Jun 30.

  PMID: 28673535 BACKGROUND

• Murthy V, Chamberlain RS. Defining a place for nipple sparing mastectomy in modern breast care: an evidence based review. Breast J. 2013 Nov-Dec;19(6):571-81. doi: 10.1111/j.1524-4741.2011.01220.x. Epub 2012 Jan 29.

  PMID: 22284266 BACKGROUND

• Weber WP, Haug M, Kurzeder C, Bjelic-Radisic V, Koller R, Reitsamer R, Fitzal F, Biazus J, Brenelli F, Urban C, Paulinelli RR, Blohmer JU, Heil J, Hoffmann J, Matrai Z, Catanuto G, Galimberti V, Gentilini O, Barry M, Hadar T, Allweis TM, Olsha O, Cardoso MJ, Gouveia PF, Rubio IT, de Boniface J, Svensjo T, Bucher S, Dubsky P, Farhadi J, Fehr MK, Fulco I, Ganz-Blattler U, Gunthert A, Harder Y, Hauser N, Kappos EA, Knauer M, Landin J, Mechera R, Meani F, Montagna G, Ritter M, Saccilotto R, Schwab FD, Steffens D, Tausch C, Zeindler J, Soysal SD, Lohsiriwat V, Kovacs T, Tansley A, Wyld L, Romics L, El-Tamer M, Pusic AL, Sacchini V, Gnant M. Oncoplastic Breast Consortium consensus conference on nipple-sparing mastectomy. Breast Cancer Res Treat. 2018 Dec;172(3):523-537. doi: 10.1007/s10549-018-4937-1. Epub 2018 Sep 4.

  PMID: 30182349 BACKGROUND

• Rowland JH, Desmond KA, Meyerowitz BE, Belin TR, Wyatt GE, Ganz PA. Role of breast reconstructive surgery in physical and emotional outcomes among breast cancer survivors. J Natl Cancer Inst. 2000 Sep 6;92(17):1422-9. doi: 10.1093/jnci/92.17.1422.

  PMID: 10974078 BACKGROUND

• Fang SY, Shu BC, Chang YJ. The effect of breast reconstruction surgery on body image among women after mastectomy: a meta-analysis. Breast Cancer Res Treat. 2013 Jan;137(1):13-21. doi: 10.1007/s10549-012-2349-1. Epub 2012 Dec 6.

  PMID: 23225142 BACKGROUND

• Rosenberger WF, Sverdlov O, Hu F. Adaptive randomization for clinical trials. J Biopharm Stat. 2012;22(4):719-36. doi: 10.1080/10543406.2012.676535.

  PMID: 22651111 BACKGROUND

• Regnault P. Breast ptosis. Definition and treatment. Clin Plast Surg. 1976 Apr;3(2):193-203.

  PMID: 1261176 BACKGROUND

• Cardoso JS, Cardoso MJ. Towards an intelligent medical system for the aesthetic evaluation of breast cancer conservative treatment. Artif Intell Med. 2007 Jun;40(2):115-26. doi: 10.1016/j.artmed.2007.02.007. Epub 2007 Apr 8.

  PMID: 17420117 BACKGROUND

• Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807.

  PMID: 19644246 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

  PMID: 19638912 BACKGROUND

• Dikmans REG, Nene LEH, Bouman MB, de Vet HCW, Mureau MAM, Buncamper ME, Winters HAH, Ritt MJPF, Mullender MG. The Aesthetic Items Scale: A Tool for the Evaluation of Aesthetic Outcome after Breast Reconstruction. Plast Reconstr Surg Glob Open. 2017 Mar 1;5(3):e1254. doi: 10.1097/GOX.0000000000001254. eCollection 2017 Mar.

  PMID: 28458968 BACKGROUND

• Mátrai Z, Gulyás G, Kovács T, Kásler M Principles and practice of oncoplastic breast surgery. Medicina Kiadó; 2019.

  BACKGROUND

• Rizki H, Nkonde C, Ching RC, Kumiponjera D, Malata CM. Plastic surgical management of the contralateral breast in post-mastectomy breast reconstruction. Int J Surg. 2013;11(9):767-72. doi: 10.1016/j.ijsu.2013.06.844. Epub 2013 Jul 8.

  PMID: 23845265 BACKGROUND

MeSH Terms

Conditions

Lymphedema; Breast Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Surgical Oncology Department

Study Record Dates

• First Submitted: April 12, 2020
• First Posted: April 22, 2020
• Study Start: April 27, 2020
• Primary Completion: April 10, 2022
• Study Completion (Estimated): April 10, 2027
• Last Updated: April 22, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)