Clinical trial NCT04677075: New Formula to Predict the Need for Reconstructive Coverage Following Mastectomy
Official title: New Formula to Predict Failure of Primary Closure and the Need for Reconstructive Coverage Following Mastectomy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Keywords: post mastectomy coverage, raw area
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-12-21
Enrollment: 74
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: breast care clinic

Brief summary: Mastectomy is a cornerstone operative procedure in breast cancer treatment leaving a raw area behind with possibility of failure of primary closure sometimes with unavailability of facilities of reconstruction. This opened the door for this research to find a formula to predict the need of reconstruction

Detailed description: Surgical intervention for breast cancer includes dealing with the primary tumour, added to it is the axillary dissection with variable options in both of them according to multiple factors. Mastectomy represents a part of several operations as radical and modified radical mastectomy, while in others it may be the whole operation as in palliative simple mastectomy. Moreover, re-excision of local recurrence is another form of surgical intervention.

At the step of mastectomy or re-excision of locally recurrent disease, the challenge of closure may arise, as simple primary closure may not be possible because of wide wound gap. In this situation, reconstruction is unavoidably needed and this situation represents one of two situations in which reconstruction is indicated.

As reconstruction sometimes needs certain expertise which may not be available momentarily and needs previous arrangement. Moreover sometimes mastectomy exceeds the previous expectation leaving a big gap beyond simple approximation, so the investigators developed a formula to assess the need of reconstructive coverage.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with breast cancer primary or recurrent, early, locally advanced or metastatic, as long as they were assigned to be treated with any procedure in which mastectomy is part or all of the procedure, were included in this study.

Exclusion Criteria:

1. Any patient diagnosed with breast cancer and planned to be treated with conservative breast cancer
2. Any patient whose design for excision was not regular ellipse but an irregularly tailored excision margin
3. Any patient with ischemic flaps (due to excessive tension or wrong dissection) following mastectomy
4. Any patient had skin disease affecting its healthiness

Primary outcomes:
measure: Clavicle-7th rib/sternal length ratio
timeFrame: for each patient at time of operation
measure: Upper flap length stretch ratio
timeFrame: for each patient at time of operation
measure: Lower flap length stretch ratio
timeFrame: for each patient at time of operation
Secondary outcomes:
measure: flap index
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine
state: Sharqia
Study officials:
References: