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

Prospective Study Evaluating Postoperative Pain and Functional Recovery After Mastectomy and Immediate Breast Reconstruction by Implant: Prepectoral Versus Subpectoral Technique

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Female
• Intervention / Treatment: Procedure: mastectomy + immediate breast reconstruction

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

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• France
  • Saint-Herblain, France, 44805
    • Institut de cancerologie de l'ouest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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	Procedure: mastectomy + immediate breast reconstruction; pre- or retro pectoral prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing quality of life and aesthetic satisfaction	breast questionary pre-post operative reconstruction module	6 months
Evaluate the function of the homolateral upper limb	Disabilities of the Arm, Shoulder and Hand self-assessment	6 months
Describe the occurrence of postoperative complications	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	duration of hospitalization	3 months
Describe the duration of drainage for all patients and according to the methods of reconstruction performed	duration of drainage in the breast and back, number of punctures and total volume of seroma punctures (classification <2)	3 months
Describe the number of surgery(s) required to obtain a good aesthetic result	number of surgery(s)	3 months
Describe the number of consultations for seroma punctures, for all patients and according to the methods of reconstruction performed	number of punctures and total volume of seroma punctures (classification <2)	3 months

Collaborators and Investigators

• Sponsor: Institut Cancerologie de l'Ouest
• Investigators: Principal Investigator: Céline RENAUDEAU, MD, celine.renaudeau@ico.unicancer.fr

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2022
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Mastectomy
• Other Study ID Numbers: ICO-2021-36

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No