NCT05391763

Brief Summary

Many surgical guidelines promote the removal of the pectoral fascia in mastectomies for invasive breast cancer, but there is no evidence to support this statement in (bilateral) prophylactic mastectomies. Reported wound-related local complications following mastectomy include seroma, flap necrosis, infection, hematoma, and nerve injury. Seroma causes discomfort and may delay the reconstructive procedures. Whether the removal or preservation of the pectoral fascia influences seroma formation following mastectomy remains unclear to our knowledge.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

1.9 years

First QC Date

May 17, 2022

Last Update Submit

January 10, 2023

Conditions

BRCA1/2 MutationBilateral Prophylactic MastectomySeromaPectoral Fascia

Outcome Measures

Primary Outcomes (2)

  • Drainproduction in milliliters

    The total drainage volume of the left and right breast in milliliters

    Until drain removal, maximum 1 week

  • Time to drain removal in days

    Number of days until drain removed

    Until drain removal, maximum 1 week

Secondary Outcomes (6)

  • Seroma (yes/no)

    Up to 6 weeks

  • Needle aspirations (number)

    Up to 6 weeks

  • Postoperative pain (score 1-10)

    Up to 6 weeks

  • Postoperative bleeding (yes/no)

    Up to 6 weeks

  • Wound related issues (yes/no)

    Up to 6 weeks

  • +1 more secondary outcomes

Study Arms (2)

Right: removal of fascia pectoralis, left: preservation of fascia pectoralis

OTHER
Procedure: Fascia pectoralis preservation

Left: removal of fascia pectoralis, right: preservation of fascia pectoralis

OTHER
Procedure: Fascia pectoralis preservation

Interventions

Fascia pectoralis preservationPROCEDURE

A total mastectomy will be performed in the control breast: a procedure which includes removal of the breast glandular tissue including the PF and subcutaneously excision of the nipple-areolar complex, while the pectoralis muscle will be spared. As much of the healthy skin envelope will be preserved to enable the performance of an effective breast reconstruction afterwards. When a nipple-sparing mastectomy is performed, the skin envelope together with the nipple-areolar complex will be spared. The investigational part of the operation is preservation of the PF. Dissection of cutaneous flaps and the breast with or without the PF will be performed with electrocautery.

Left: removal of fascia pectoralis, right: preservation of fascia pectoralisRight: removal of fascia pectoralis, left: preservation of fascia pectoralis

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patient
  • Scheduled for a bilateral prophylactic mastectomy in the Erasmus MC Academic Breast Cancer Centre in Rotterdam
  • Ability to give written consent
  • Adequate understanding of Dutch language

You may not qualify if:

  • History of diagnosis of invasive breast cancer or ductal carcinoma in situ (DCIS)
  • Other malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus Medical Center

Rotterdam, Netherlands

RECRUITING

Related Publications (1)

  • Clarijs ME, van Egdom LSE, Verhoef C, Vasilic D, Koppert LB; PROFAS Collaborator Group. Bilateral prophylactic mastectomy: should we preserve the pectoral fascia? Protocol of a Dutch double blinded, prospective, randomised controlled pilot study with a within-subject design (PROFAS). BMJ Open. 2023 Feb 17;13(2):e066728. doi: 10.1136/bmjopen-2022-066728.

    PMID: 36806067DERIVED

MeSH Terms

Conditions

Seroma

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Marloes Clarijs, MD

CONTACT

+31 6 22035529m.clarijs@erasmusmc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
The patient and the observer for drain volume are both blinded for their assigned breast randomization. The surgeon(s) and coordinating researcher will not be blinded, and are therefore not allowed to measure the drain production.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 17, 2022

First Posted

May 26, 2022

Study Start

January 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

January 11, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)