New Formula to Predict the Need for Reconstructive Coverage Following Mastectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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New Formula to Predict the Need for Reconstructive Coverage Following Mastectomy

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Procedure: mastectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients needs total mastectomy for management of their breast condition Exclusion Criteria: Patient with breast disease treated surgically by any intervention other than total mastectomy Patients with skin disease affecting its stretchability
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mastectomy group<br>patients with breast cancer and eligible for mastectomy | Procedure: mastectomy<br>* mastectomy either simple or modified radical<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sternal length | the length of the sternum in cm | for each patient at time of operation | 
| Upper flap length | the perpendicular line from the highest point of the upper border of mastectomy ellipse to the clavicle in cm | for each patient at time of operation | 
| Lower flap length | the perpendicular line from the lowest point of the lower border of mastectomy ellipse to the 7th rib in cm | for each patient at time of operation | 
| flap index | 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 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post mastectomy coverage, raw area