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.
Study Overview
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Sharqia
-
Zagazig, Sharqia, Egypt, 44519
- Faculty of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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:
- Any patient diagnosed with breast cancer and planned to be treated with conservative breast cancer
- Any patient whose design for excision was not regular ellipse but an irregularly tailored excision margin
- Any patient with ischemic flaps (due to excessive tension or wrong dissection) following mastectomy
- Any patient had skin disease affecting its healthiness
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
mastectomy group
patients with breast cancer and eligible for mastectomy
|
mastectomy either simple or modified radical
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clavicle-7th rib/sternal length ratio
Time Frame: for each patient at time of operation
|
the ratio of clavicle-7th rib in relation to the length of the sternum
|
for each patient at time of operation
|
|
Upper flap length stretch ratio
Time Frame: for each patient at time of operation
|
the 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
|
for each patient at time of operation
|
|
Lower flap length stretch ratio
Time Frame: for each patient at time of operation
|
the 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
|
for each patient at time of operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
flap index
Time Frame: through study completion, an average of 3 years
|
entangling 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
|
through study completion, an average of 3 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- mastectomy coverage formula 20
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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