Clinical trial NCT05527769: Pain and Functional Recovery After Mastectomy and IBR by Implant: Prepectoral Versus Subpectoral Technique
Official title: Prospective Study Evaluating Postoperative Pain and Functional Recovery After Mastectomy and Immediate Breast Reconstruction by Implant: Prepectoral Versus Subpectoral Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Female
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major patients followed for breast cancer with indication of mastectomy with immediate breast reconstruction by prosthesis.

Brief 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

Eligibility criteria: Inclusion Criteria:

1. Major patients
2. With breast cancer and indication for total mastectomy
3. With a desire for immediate breast reconstruction
4. Total mastectomy procedure and Immediate Breast Reconstruction by Pre-pectoral or Retro-Pectoral prosthesis
5. Information of the patient and collection of his/her non-opposition
6. Affiliation with a social securitý scheme, or beneficiary of such a scheme

Exclusion Criteria:

1. Prophylactic mastectomies
2. Metastatic patients
3. Patients requiring another surgical technique
4. 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,
5. Impossibility to submit to the medical follow-up of the trial for geographical, social or psychological reasons
6. Pregnant or likely to be pregnant

Primary outcomes:
measure: Describe postoperative pain and functional results
timeFrame: 6 month
Secondary outcomes:
measure: Assessing quality of life and aesthetic satisfaction
timeFrame: 6 months
measure: Evaluate the function of the homolateral upper limb
timeFrame: 6 months
measure: Describe the occurrence of postoperative complications
timeFrame: 3 months
measure: Describe the length of operative stay (for the initial reconstruction), for all patients and according to the methods of reconstruction performed
timeFrame: 3 months
measure: Describe the duration of drainage for all patients and according to the methods of reconstruction performed
timeFrame: 3 months
measure: Describe the number of surgery(s) required to obtain a good aesthetic result
timeFrame: 3 months
measure: Describe the number of consultations for seroma punctures, for all patients and according to the methods of reconstruction performed
timeFrame: 3 months
Other outcomes:
Locations:
city: Saint-Herblain
country: France
facility: Institut de Cancerologie de L'Ouest
Study officials:
affiliation: celine.renaudeau@ico.unicancer.fr
name: Céline RENAUDEAU, MD
role: PRINCIPAL_INVESTIGATOR
References: