New Formula to Predict the Need for Reconstructive Coverage Following Mastectomy

NCT04677075 | Completed

• 1 other identifier: mastectomy coverage formula 20
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Breast Neoplasms

Keywords

post mastectomy coverage, raw area

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• flap index

  through study completion, an average of 3 years

Study Arms (1)

mastectomy group

patients with breast cancer and eligible for mastectomy

Procedure: mastectomy

Interventions

mastectomy PROCEDURE

mastectomy either simple or modified radical

mastectomy group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

breast care clinic

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of Medicine

Zagazig, Sharqia Province, 44519, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of surgery

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 21, 2020
• Study Start: August 15, 2020
• Primary Completion: August 15, 2023
• Study Completion: September 15, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

EG (1)