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New Formula to Predict the Need for Reconstructive Coverage Following Mastectomy

Z

Zagazig University

Status

Completed

Conditions

Breast Neoplasms

Treatments

Procedure: mastectomy

Study type

Observational

Funder types

Other

Identifiers

NCT04677075
mastectomy coverage formula 20

Details and patient eligibility

About

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

Full 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.

Enrollment

74 patients

Sex

Female

Volunteers

No Healthy Volunteers

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

Trial design

74 participants in 1 patient group

mastectomy group
Description:
patients with breast cancer and eligible for mastectomy
Treatment:
Procedure: mastectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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