Pain and Functional Recovery After Mastectomy and IBR by Implant: Prepectoral Versus Subpectoral Technique

NCT ID: NCT05527769

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-07
• Study Completion Date: 2023-11-30

Brief Summary

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.

Detailed 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

Conditions

Breast Cancer Female

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

pre-pectoral prosthesis

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

mastectomy + immediate breast reconstruction

Intervention Type: PROCEDURE

pre- or retro pectoral prosthesis

retropectoral prosthesis

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

mastectomy + immediate breast reconstruction

Intervention Type: PROCEDURE

pre- or retro pectoral prosthesis

Interventions

mastectomy + immediate breast reconstruction

pre- or retro pectoral prosthesis

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Cancerologie de l'Ouest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Céline RENAUDEAU, MD

Role: PRINCIPAL_INVESTIGATOR

celine.renaudeau@ico.unicancer.fr

Locations

Institut de Cancerologie de L'Ouest

Saint-Herblain, , France

Countries

France

Other Identifiers

ICO-2021-36

Identifier Type: -

Identifier Source: org_study_id