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| Sponsor: | Tel-Aviv Sourasky Medical Center |
|---|---|
| Information provided by: | Tel-Aviv Sourasky Medical Center |
| ClinicalTrials.gov Identifier: | NCT00748722 |
Purpose
Abdominal donor-site flaps, including the transverse rectus abdominis musculocutaneous (TRAM) and deep inferior epigastric artery perforator flaps(DIEP), are standard in autologous breast reconstruction. With significant variation in the vascular anatomy of the abdominal wall, preoperative imaging is essential for preoperative planning and reducing intraoperative error.
The quest continues for optimal preoperative assessment. Computed tomographic angiography has recently been proposed as a noninvasive modality for this purpose. It provides the location of the perforator vessels, diameter and anatomic course in regards to the rectus muscle.
In this study we will perform preoperative lower abdominal computed tomographic angiography in DIEP flap breast reconstruction patients.
| Condition | Intervention |
|---|---|
|
Breast Reconstruction |
Device: CT Angiography |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Pre-Operative Imaging of Abdominal Wall Perforators Using CT Angiography for DIEP Breast Reconstruction |
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Female patients, age 18-60 years, suitable for breast reconstruction using the lower abdominal tissue.
|
Device: CT Angiography
Injection of contrast material (iodine)
Other Name: Iodine
|
Abdominal donor-site flaps, including the transverse rectus abdominis musculocutaneous (TRAM) and deep inferior epigastric artery perforator flaps(DIEP), are standard in autologous breast reconstruction. With significant variation in the vascular anatomy of the abdominal wall, preoperative imaging is essential for preoperative planning and reducing intraoperative error.
The quest continues for optimal preoperative assessment. Computed tomographic angiography has recently been proposed as a noninvasive modality for this purpose. It provides the location of the perforator vessels, diameter and anatomic course in regards to the rectus muscle.
In this study we will perform preoperative lower abdominal computed tomographic angiography in DIEP flap breast reconstruction patients.
We plan to study 20 patients, eligible for lower abdominal-based breast reconstruction.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Female patients, age 18-60 years eligible for lower abdominal breast reconstruction
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Israel | |
| Tel-Aviv Medical Center | |
| Tel-Aviv, Israel, 64239 | |
| Study Chair: | Yoav Barnea, MD | Tel Aviv Medical Center |
| Principal Investigator: | Arie Blachar, MD | Tel Aviv Medical Center |
| Principal Investigator: | Eyal Gur, MD | Tel Aviv Medical Center |
More Information
| Responsible Party: | Yoav Barnea, MD, Tel Aviv Medical Center |
| ClinicalTrials.gov Identifier: | NCT00748722 History of Changes |
| Other Study ID Numbers: | TASMC-08-YB-0181-CTIL |
| Study First Received: | July 15, 2008 |
| Last Updated: | September 7, 2008 |
| Health Authority: | Israel: Ministry of Health |
|
Breast reconstruction Perforator flaps CT Angiography |
