Pain and Functional Recovery After Mastectomy and IBR by Implant: Prepectoral Versus Subpectoral … (NCT05527769) | Clinical Trial Compass
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 range18 Years
SexFEMALE
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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,
What they're measuring
1
Describe postoperative pain and functional results