New Formula to Predict the Need for Reconstructive Coverage Following Mastectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-15

Study Completion Date

2023-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Outcomes of Fat Grafting Combined With Latissimus Dorsi Muscle Flap for Delayed Breast Reconstruction After Mastectomy

NCT07331753

Breast Cancer Breast Reconstruction

RECRUITING NA

Long Term Function Outcomes and Pain in Implant-based Post-mastectomy Breast Reconstruction

NCT04477538

Post-mastectomy Breast Reconstruction

TERMINATED

Reconstruction of Partial Mastectomy Defects With Pectoralis Myo-glandular Local Flap.

NCT04091958

Breast Cancer

UNKNOWN PHASE1

Stellate Ganglion Block for Prevention of Post Mastectomy Depression

NCT06263907

Mastectomy Pain, Acute Pain, Chronic

RECRUITING NA

Prosthetic Breast Reconstruction After Mastectomy

NCT06774352

Breast Reconstruction

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

mastectomy group

patients with breast cancer and eligible for mastectomy

mastectomy

Intervention Type PROCEDURE

mastectomy either simple or modified radical

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

mastectomy

mastectomy either simple or modified radical

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No