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NCT Number: NCT05527769

Pain and Functional Recovery After Mastectomy and IBR 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.

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Key information

Conditions

Breast Cancer Female

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Institut de Cancerologie de L'Ouest

Saint-Herblain, 44805, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

mastectomy + immediate breast reconstruction

Procedure

pre- or retro pectoral prosthesis

Primary outcomes

  1. Describe postoperative pain and functional results

    Time frame: 6 month

    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

Secondary outcomes

  1. Assessing quality of life and aesthetic satisfaction

    Time frame: 6 months

    breast questionary pre-post operative reconstruction module

  2. Evaluate the function of the homolateral upper limb

    Time frame: 6 months

    Disabilities of the Arm, Shoulder and Hand self-assessment

  3. Describe the occurrence of postoperative complications

    Time frame: 3 months

    postoperative complications

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

    Time frame: 3 months

    duration of hospitalization

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

    Time frame: 3 months

    duration of drainage in the breast and back, number of punctures and total volume of seroma punctures (classification <2)

  6. Describe the number of surgery(s) required to obtain a good aesthetic result

    Time frame: 3 months

    number of surgery(s)

  7. Describe the number of consultations for seroma punctures, for all patients and according to the methods of reconstruction performed

    Time frame: 3 months

    number of punctures and total volume of seroma punctures (classification <2)

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Official study title

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

Acronym: DREAM-RMI

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 6, 2022
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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