New Formula to Predict the Need for Reconstructive Coverage Following Mastectomy

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04677075
• Other study ID #: mastectomy coverage formula 20
• Status: Completed
• Start date: August 15, 2020
• Est. completion date: September 15, 2023

Study information

• Verified date: February 2024
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: September 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Procedure:
• mastectomy
mastectomy either simple or modified radical

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Zagazig	Sharqia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clavicle-7th rib/sternal length ratio	the ratio of clavicle-7th rib in relation to the length of the sternum	for each patient at time of operation
Primary	Upper flap length stretch ratio	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
Primary	Lower flap length stretch ratio	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	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 years