Breast Reconstruction by Exclusive Lipomodulin : Feasibility, Evaluation of the Aesthetic Result and Quality of Life

NCT04625621 | Completed

• 1 other identifier: ICO-2020-22
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the leading female cancer in metropolitan France in terms of incidence and death. Among the therapeutic arsenal for the treatment of these cancers, surgery plays a very important role and even if a conservative treatment is possible in the majority of cases, there is still an indication for mastectomy in about 30% of cases. Currently, only 30% of women who have undergone a mastectomy choose reconstruction. The primary objective of breast reconstruction from a surgical point of view is to leave as few aesthetic and functional after-effects as possible while meeting the personal wishes of each woman according to her morphological, tissue and vascular characteristics. There are currently 2 major surgical procedures for breast reconstruction: breast implant reconstructions and autologous reconstructions. Breast reconstruction by prosthesis is the simplest and most widely used technique but, the controversies concerning implants with the PIP breast prostheses scandal in 2010 and more recently the anaplastic lymphoma scandal have tarnished the image of this type of reconstruction. Alternatives to breast implants have been developed: autologous reconstructions using first pedicled tissue flaps, then free flaps, techniques that allow a more natural, more satisfactory aesthetic result with an evolution that follows the patient's own morphology but requiring specific training in microsurgery and not without postoperative complications. Since 1999, the investigators have witnessed the evolution of another autologous technique, that of lipomodulin. Initially used to improve the results of reconstructions and the aesthetic sequelae of conservative treatments, it is now used as an exclusive reconstruction technique. Easily reproducible and offering several advantages, reconstruction by exclusive lipomodulin is increasingly appreciated by patients. However, this increasingly practiced technique presents specific problems and this is what the investigators want to evaluate in this study. The main objective of this study is to evaluate the practices within our establishment regarding breast reconstruction by exclusive lipomodulin in terms of feasibility. The secondary objectives are the evaluation of the cosmetic result and the quality of life of these patients after this type of reconstruction.

Conditions

Breast Cancer; Mastectomy; Lymphedema

Outcome Measures

Primary Outcomes (1)

• Evaluate the feasibility of the exclusive lipomodulin technique in breast reconstruction: Failure rate of the technique

  Failure rate of the technique

  18 months

Secondary Outcomes (3)

• Evaluate the aesthetic result

  18 months

• Evaluate patient satisfaction: BREAST-Q

  6 months

• Assessing patient quality of life: WHOQOL BREF

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient treated by mastectomy for breast cancer having completed an exclusive lipomodeling reconstruction course (immediate or delayed reconstruction) at the ICO - Saint Herblain site between January 2012 and July 2020.

You may qualify if:

• Patients over 18 years of age
• Patient who benefited from immediate or delayed breast reconstruction by exclusive lipomodulin completed between 01/01/2012 and 07/31/2020.
• Agreeing to answer the questionnaire

You may not qualify if:

• Association with another prosthetic or autologous reconstruction technique planned at the beginning of the reconstruction procedure.
• Deceased patient
• Patient under guardianship or curators
• Patient opposed to the use of her data for research

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (1)

Institut de Cancerologie de L'Ouest

Saint-Herblain, 44805, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

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

Study Officials

• BRILLAUD-MEFLAH Victoire, MD

  Institut de Cancérologie de l'Ouest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: November 12, 2020
• Study Start: November 26, 2020
• Primary Completion: January 5, 2021
• Study Completion: February 5, 2021
• Last Updated: February 13, 2026

Record last verified: 2021-03

Locations

FR (1)