CompletedNot Applicable

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

France27 participantsStarted 2022-09-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Describe postoperative pain and functional results

Timeframe: 6 month

Trial details

NCT IDNCT05527769

SponsorInstitut Cancerologie de l'Ouest

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-11-30

View on ClinicalTrials.gov More Breast Cancer Female trials