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

NCT05527769 | Completed

• 1 other identifier: ICO-2021-36
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• Describe postoperative pain and functional results

  Brief Pain Inventory (BPI) short form - 4 scales from 1 (No pain) to 10 (max pain) + 7 scales from 1 (no discomfort) to 10 (max discomfort) to determine if the pain interfered with activities of daily living

  6 month

Secondary Outcomes (7)

• Assessing quality of life and aesthetic satisfaction

  6 months

• Evaluate the function of the homolateral upper limb

  6 months

• Describe the occurrence of postoperative complications

  3 months

• Describe the length of operative stay (for the initial reconstruction), for all patients and according to the methods of reconstruction performed

  3 months

• Describe the duration of drainage for all patients and according to the methods of reconstruction performed

  3 months

Study Arms (2)

pre-pectoral prosthesis

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

Procedure: mastectomy + immediate breast reconstruction

retropectoral prosthesis

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

Procedure: mastectomy + immediate breast reconstruction

Interventions

mastectomy + immediate breast reconstruction PROCEDURE

pre- or retro pectoral prosthesis

pre-pectoral prosthesis; retropectoral prosthesis

Eligibility Criteria

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

Study Population

Major patients followed for breast cancer with indication of mastectomy with immediate breast reconstruction by prosthesis.

You may qualify if:

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

You may not qualify if:

• Prophylactic mastectomies
• Metastatic patients
• Patients requiring another surgical technique
• 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,
• Impossibility to submit to the medical follow-up of the trial for geographical, social or psychological reasons
• Pregnant or likely to be pregnant

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (1)

Institut de Cancerologie de L'Ouest

Saint-Herblain, 44805, France

Location

MeSH Terms

Interventions

Mastectomy

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Céline RENAUDEAU, MD

  celine.renaudeau@ico.unicancer.fr

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 6, 2022
• Study Start: September 7, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: February 13, 2026

Record last verified: 2023-09

Locations

FR (1)