Clinical Trials Directory

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

TypeNameDescription
PROCEDUREmastectomy + immediate breast reconstructionpre- 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.