Shaving as an Safe Alternative to Frozen Section Analysis

ConditionEarly Stage Breast Cancer

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorMark Ezzat Gerges

About this trial

Evaluation of Tumor Bed Cavity Shaving as an Oncologically Safe Alternative to Frozen Section Analysis in Breast-Conserving Surgery and aim of study To assess the oncological safety and practicality of tumor bed cavity shaving also aims to evaluate its impact on operative time and overall cost.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged ≥18 years.

Diagnosed with unifocal, operable invasive breast carcinoma.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

Tumor bed cavity shaving
Procedure/Surgery
feasible in centers lacking intraoperative pathological facilities. * Time saving (significantly reduces the overall operative time). * cost-effectiveness. * Technically simple (Easy to perform without the need for specialized equipment or advanced facilities). * it represents a suitable option in low- to medium-socioeconomic settings, where resources and advanced intraoperative support may be limited. * It is expected to demonstrate comparable oncological safety to Intraoperative Frozen Section Analysis (FSA) in achieving margin negativity with Significant reduction anticipated in Positive margin rates\&Re-excision frequency\&Operative duration and Overall procedural cost.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Tumor bed cavity shaving armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Rate of positive margins and re-excision within 2 years post-surgery

Percentage of patients whose surgical pathology shows positive margins, and percentage of patients who undergo re-excision. Assessment will be based on histopathology reports and surgical records. Unit of Measure: percentage number of patients Measurement Tool: Histopathological examination (pathology report) for margin status; surgical database/operative logs for re-excision events.

Time frame

From time of enrollment of the patient until 2 years post-operative

Secondary outcomes

- Cost-effectiveness - Facilities availability - Impact on intraoperative time

1. Cost-effectiveness Description: Total direct cost incurred per patient from surgery through 2 years of follow-up, including operative costs, pathology, imaging, and any re-operations. Unit of Measure: Currency Measurement Tool: cost-analysis using hospital accounting data. 2. Facilities availability Description: Frequency of use and availability of required surgical infrastructure during the study period. Unit of Measure: Number / proportion (for example, number of surgeries per facility per month, or percentage of scheduled surgeries using the study's protocol) Measurement Tool: Hospital operation records, facility logbooks or administrative databases. 3. Impact on intraoperative time Description: Difference in surgical duration (minutes) between standard procedure and the procedure under study, if applicable. Unit of Measure: Minutes Measurement Tool: Operative records / anesthesia records. Time Frame: from incision to closure.

Time frame

From enrollment time of the patient until 2 years post operative

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mark Ezzat Gerges

Lead sponsor

Assiut University

Sponsor institution

Source ClinicalTrials.gov

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