To assess a pilot-study on the impact of removal versus preservation of the pectoral fascia on total drain volume, time to drain removal and needle aspirations (and thus seroma) in women undergoing bilateral prophylactic mastectomy.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Breast therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Impact of removal versus preservation of the pectoral fascia on seroma
formation. The drain production and the number of days the drain will be left
in situ will be measured. The volume of 30 ml in 24 hours is established as a
guideline for timing of drain removal. Seroma is defined as any clinically
detected collection of fluid requiring aspiration.The number of needle
aspirations and volume in ml will be reported.
Secondary outcome
Impact of removal versus preservation of the pectoral fascia on postoperative
pain, wound related issues as hematoma and infection, and hospitalization
duration will be reported.
Background summary
Many surgical guidelines recommend the removal of the fascia to ensure
radicality. However, there is no evidence to support this statement in early
operable breast cancer, and certainly not in prophylactic mastectomies. A
thorough research on literature shows numerous citations to the fact that the
fascia should be removed, but no explanation whatsoever to why this should be
done.
Reported wound related local complications following modified radical
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 post-operative
seroma formation and thus drainpolicy (e.g. total drain volume, time to
removal) following mastectomy remains unclear. Our hypothesis is that
preservation of the pectoral fascia may lead to a decreased total drain volume,
time to drain removal and needle aspirations (and thus seroma formation) when
compared to fascia removal.
Study objective
To assess a pilot-study on the impact of removal versus preservation of the
pectoral fascia on total drain volume, time to drain removal and needle
aspirations (and thus seroma) in women undergoing bilateral prophylactic
mastectomy.
Study design
A double blinded, prospective, randomized controlled pilot-study with a
within-subject design.
Intervention
All patients will undergo a bilateral prophylactic mastectomy. Randomization
will occur within the patient, with each breast randomized between preservation
and removal of the pectoral fascia
Study burden and risks
No extra risks are associated to participation in the study, since the
procedure was declared safe. Additional recorded variables will be monitored by
the research team (i.e. nurses, breast surgeons, researcher), including
hospital stay, the duration of drain use, the total drain volume, and if
applicable wound related issues as hematoma and infection, the total volume of
aspirated seroma fluid and the number of needle aspirations (after drain
removal). In conclusion, with exception of preservation of the pectoral fascia
(in one breast) all the procedures will be performed according to the standard
protocol for bilateral prophylactic mastectomy as defined by the Erasmus MC
Cancer Institute
Dr.Molewaterplein 40
Rotterdam 3015 GD
NL
Dr.Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Female and age 18 years or older
- Scheduled for bilateral prophylactic mastectomy
Exclusion criteria
Diagnosis of breast cancer
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL72939.078.20 |