Skip to main content
OpenTrials
Completed

NCT Number: NCT04677075

New Formula to Predict the Need for Reconstructive Coverage Following Mastectomy

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

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

Female

Study type

Observational

Primary location

Faculty of Medicine

Zagazig, Sharqia Province, 44519, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mastectomy

Procedure

mastectomy either simple or modified radical

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 21, 2020
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.