Pain and Functional Recovery After Mastectomy and IBR by Implant: Prepectoral Versus Subpectoral Technique (DREAM-RMI)

Institut Cancerologie de l'Ouest

Status: Completed

Conditions: Breast Cancer Female

Treatments: Procedure: mastectomy + immediate breast reconstruction

Study type: Observational

Funder types: Other

Identifiers

NCT05527769

ICO-2021-36

Details and patient eligibility

About

This is a prospective, single-center, non-randomized study of immediate breast reconstruction (IBR) using a pre- or retro-pectoral technique in patients with breast cancer who have undergone total mastectomy.

The technique used is chosen according to the characteristics of the breast, the morphology of the patient and her wishes after informed information on the different techniques. The aim is not to compare the two techniques but rather to evaluate the early functional results of these two methods in order to better understand them and to propose a management adapted to each.

The main objective will be to evaluate the postoperative pain by BPI questionnaire.

The investigators also wish to observe the functional results of the homolateral upper limb by DASH questionnaire, the quality of life by BREAST Q questionnaire and the occurrence of complications.

Full description

describe the occurrence of complications between pre-pectoral and retro-pectoral technique in patients with breast cancer who have total mastectomy.

evaluate the postoperative pain by Brief Pain Inventory (BPI) self assesment observe the functional results of the homolateral upper limb by Disabilities of the Arm, Shoulder and Hand (DASH) self assesment observe quality of life by BREAST Q questionary

Enrollment: 27 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Major patients
2. With breast cancer and indication for total mastectomy
3. With a desire for immediate breast reconstruction
4. Total mastectomy procedure and Immediate Breast Reconstruction by Pre-pectoral or Retro-Pectoral prosthesis
5. Information of the patient and collection of his/her non-opposition
6. Affiliation with a social securitý scheme, or beneficiary of such a scheme

Exclusion criteria

1. Prophylactic mastectomies
2. Metastatic patients
3. Patients requiring another surgical technique
4. Person in an emergency situation, person of legal age under legal protection (adult under guardianship, curators or safeguard of justice), or unable to express consent,
5. Impossibility to submit to the medical follow-up of the trial for geographical, social or psychological reasons
6. Pregnant or likely to be pregnant

Trial design

27 participants in 2 patient groups

pre-pectoral prosthesis

Description:

breast cancer patients with an indication for total mastectomy + immediate breast reconstruction (IBR) by prosthesis using a pre-pectoral technique

Treatment:

Procedure: mastectomy + immediate breast reconstruction

retropectoral prosthesis

Description:

breast cancer patients with an indication for total mastectomy + immediate breast reconstruction (IBR) by prosthesis using the retropectoral technique

Treatment:

Procedure: mastectomy + immediate breast reconstruction