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

Breast Cancer Female Clinical Trial

— DREAM-RMI  

Official title:

Prospective Study Evaluating Postoperative Pain and Functional Recovery After Mastectomy and Immediate Breast Reconstruction by Implant: Prepectoral Versus Subpectoral Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05527769
• Other study ID #: ICO-2021-36
• Status: Completed
• Start date: September 7, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: September 2023
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 security´ 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

Related Conditions & MeSH terms

• Breast Cancer Female

Intervention

Procedure:
• mastectomy + immediate breast reconstruction
pre- or retro pectoral prosthesis

Locations

Country	Name	City	State
France	Institut de Cancerologie de L'Ouest	Saint-Herblain

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Describe postoperative pain and functional results	Brief Pain Inventory (BPI) short form - 4 scales from 1 (No pain) to 10 (max pain) + 7 scales from 1 (no discomfort) to 10 (max discomfort) to determine if the pain interfered with activities of daily living	6 month
Secondary	Assessing quality of life and aesthetic satisfaction	breast questionary pre-post operative reconstruction module	6 months
Secondary	Evaluate the function of the homolateral upper limb	Disabilities of the Arm, Shoulder and Hand self-assessment	6 months
Secondary	Describe the occurrence of postoperative complications	postoperative complications	3 months
Secondary	Describe the length of operative stay (for the initial reconstruction), for all patients and according to the methods of reconstruction performed	duration of hospitalization	3 months
Secondary	Describe the duration of drainage for all patients and according to the methods of reconstruction performed	duration of drainage in the breast and back, number of punctures and total volume of seroma punctures (classification <2)	3 months
Secondary	Describe the number of surgery(s) required to obtain a good aesthetic result	number of surgery(s)	3 months
Secondary	Describe the number of consultations for seroma punctures, for all patients and according to the methods of reconstruction performed	number of punctures and total volume of seroma punctures (classification <2)	3 months