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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00693 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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Many hospitals, including the Ohio State University Medical Center, will take pictures of the blood vessels in a patient's abdomen before they decide to perform a breast reconstruction using the patient's own tissue. These pictures are called computed tomography (CT) angiograms and are like a map of each patient's anatomy. However, no study has been reported that determined how accurate these pictures are at showing the surgeon where all of the blood vessels were located. This study will try to determine if these pictures are missing any blood vessels that are found during surgery and if the pictures show the correct location of the vessels
PRIMARY OBJECTIVES:
I. To analyze the accuracy of preoperative CT angiography in determining the location of perforator vessels. Through the use of an intraoperative navigation system, we will objectively locate perforators during surgery and compare the results to the preoperative imaging assessment of the flap's vascular anatomy.
II. To determine whether the preoperative CT angiogram allows the microsurgeon to correctly identify the perforators that are ultimately used as the pedicle for the flap.
OUTLINE:
Patients undergo deep inferior epigastric perforator (DIEP) flap breast reconstruction using the StealthStation navigation system.
After completion of study treatment, patients are followed up at 1-2 weeks and 1 month, then every 3 months for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (image-guided breast reconstruction) | Experimental | Patients undergo DIEP flap breast reconstruction using the StealthStation navigation system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| breast reconstruction | Procedure | Undergo DIEP flap breast reconstruction using the StealthStation navigation system |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of perforators that are found intraoperatively but not seen preoperatively on CT angiogram images | Up to 2 years | |
| Whether the preoperative CT angiography allowed the surgeon to accurately predict the perforator vessels that were actually used in the final flap design and transfer | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Position of the vessels on the imaging correlate to actual location on the abdominal wall for those perforator vessels that are identified both on preoperative review of the images and located during flap dissection | Up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ergun Kocak, MD | Ohio State University | Principal Investigator |
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| Label | URL |
|---|---|
| Jamesline | View source |
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|
| intraoperative imaging | Procedure | Undergo DIEP flap breast reconstruction using the StealthStation navigation system |
|
| ID | Term |
|---|---|
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D000071960 | Breast Carcinoma In Situ |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D016462 | Mammaplasty |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
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