Clinical trial NCT04716959: Comparing Two Different Surgical Techniques for Breast Reconstruction
Official title: A Randomized Controlled Trial of Prepectoral Versus Subpectoral Prosthetic Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Breast Reconstruction
Keywords: Prosthetic
Breast tissue expander
20-565
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two standard techniques for breast reconstruction-the prepectoral technique and the subpectoral technique. Again, the prepectoral technique involves putting a tissue expander on top of the pectoralis muscle, while the subpectoral technique involves putting a tissue expander under the pectoralis muscle.

The standard approach used at MSK is the subpectoral technique. This study will help researchers find out whether the subpectoral approach is better, the same as, or worse than the prepectoral approach. To decide which approach is better, the researchers will look at which technique causes fewer complications after surgery (for example, infection or the need for a second surgery). Researchers are also interested in seeing which approach causes less pain and use of pain medication after surgery.


Eligibility criteria: Inclusion Criteria:

* Women aged 21-60 years
* Planning to undergo immediate two stage prosthetic breast reconstruction with TE placement as the first stage.
* Planning to undergo unilateral or bilateral mastectomy.
* Planning to undergo nipple- or skin-sparing mastectomy.
* Mastectomy weight less than 800 grams.
* Adequate mastectomy skin perfusion or patients with adequate perfusion but nonviable mastectomy skin that can be excised (≤ 4 cm) at the defect margins with otherwise adequate perfusion.

Exclusion Criteria:

* Receipt of neoadjuvant chemotherapy for locally advanced breast cancer.
* Presence of preoperative axillary lymph node metastasis.
* Presence of intraoperative sentinel node positivity.
* History of radiotherapy.
* Current smoker.
* Planning to undergo direct-to-implant reconstruction.
* BMI \>35.
* Prior sternotomy.

Primary outcomes:
measure: major perioperative complications
timeFrame: 90 days
Secondary outcomes:
measure: minor complications
timeFrame: 90 days
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering BaskingRidge (Consent and Followup)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent and Followup)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent and Followup )
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent and Followup)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent and Followup)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (Consent and Followup)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Evan Matros, MD, MMSc, MPH
role: PRINCIPAL_INVESTIGATOR
References: