Trials / Completed
CompletedNCT05527769
Pain and Functional Recovery After Mastectomy and IBR by Implant: Prepectoral Versus Subpectoral Technique
Prospective Study Evaluating Postoperative Pain and Functional Recovery After Mastectomy and Immediate Breast Reconstruction by Implant: Prepectoral Versus Subpectoral Technique
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 27 (actual)
- Sponsor
- Institut Cancerologie de l'Ouest · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | mastectomy + immediate breast reconstruction | pre- or retro pectoral prosthesis |
Timeline
- Start date
- 2022-09-07
- Primary completion
- 2023-11-30
- Completion
- 2023-11-30
- First posted
- 2022-09-06
- Last updated
- 2026-02-13
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05527769. Inclusion in this directory is not an endorsement.