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New Formula to Predict the Need for Reconstructive Coverage Following Mastectomy

New Formula to Predict Failure of Primary Closure and the Need for Reconstructive Coverage Following Mastectomy.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04677075
Enrollment
74
Registered
2020-12-21
Start date
2020-08-15
Completion date
2023-09-15
Last updated
2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

post mastectomy coverage, raw area

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.

Interventions

PROCEDUREmastectomy

mastectomy either simple or modified radical

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clavicle-7th rib/sternal length ratiofor each patient at time of operationthe ratio of clavicle-7th rib in relation to the length of the sternum
Upper flap length stretch ratiofor each patient at time of operationthe ratio of the perpendicular line from the highest point of the upper border of mastectomy ellipse to the clavicle originally in relation to the length after stretch
Lower flap length stretch ratiofor each patient at time of operationthe ratio of the perpendicular line from the lowest point of the lower border of mastectomy ellipse to the 7th rib originally to the length after stretch

Secondary

MeasureTime frameDescription
flap indexthrough study completion, an average of 3 yearsentangling of the above measurement in an equation to yield a number so when the distance from the clavicle to the 7th rib (in the midclavicular plane) is subtracted from it, a number is yielded, predicting the feasibility of closure without need to reconstruction

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026