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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.
Breast cancer remains the most common malignancy among women worldwide and represents a major health burden. Breast-conserving surgery (BCS) has become the standard of care for early-stage breast cancer, aiming to achieve complete tumor excision with histologically clear margins combined with adjuvant radiotherapy, offers equivalent survival rates to mastectomy in early-stage cases.
. Positive surgical margins are strongly associated with increased rates of local recurrence and frequently necessitate re-excision.
Traditionally, intraoperative frozen section analysis (FSA) has been used to assess margin status. However, this technique has several drawbacks, including:
Limited availability in many centers.
Requires high-experienced cytopathologists making it challenging in resource-limited places.
Adds substantial cost.
Time consuming (prolonged operative time).
tumor bed cavity shaving (TBCS) means additional thin layers of tissue approximately 5:10 mm in thickness are removed circumferentially from the cavity walls .
With many advantages:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tumor bed cavity shaving arm | Experimental | Patients undergoing breast-conserving surgery will receive intraoperative tumor bed cavity shaving as an alternative approach to ensure clear surgical margins. Additional cavity shavings will be taken circumferentially after the primary lumpectomy specimen. The outcomes will be compared with standard margin assessment methods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor bed cavity shaving | Procedure | feasible in centers lacking intraoperative pathological facilities.
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From time of enrollment of the patient until 2 years post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| - Cost-effectiveness - Facilities availability - Impact on intraoperative time |
Unit of Measure: Minutes Measurement Tool: Operative records / anesthesia records. Time Frame: from incision to closure. |
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Inclusion Criteria:
Exclusion criteria:
-Contraindication of Breast-Conserving Surgery.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Ezzat Gerges, Resident doctor | Contact | +201229385677 | markezzat99@gmail.com | |
| Nagm elden Abu elnaga, Ph D | Contact | +201015417979 | nagmdairy@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mostafa Thabet | Assiut University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Assiut University | Asyut | 71515 | Egypt |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| From enrollment time of the patient until 2 years post operative |
| D017437 |
| Skin and Connective Tissue Diseases |