Pre-Operative Imaging of Abdominal Wall Perforators Using CT Angiography (DIEP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00748722
First received: July 15, 2008
Last updated: September 7, 2008
Last verified: September 2008
  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

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 1 year from starting date [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Detailed Description:

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
Study Population

Female patients, age 18-60 years eligible for lower abdominal breast reconstruction

Criteria

Inclusion Criteria:

  • Female, age 18-60 years
  • Appropriate for lower abdominal based breast reconstruction.
  • Consented the use of CT Angiography

Exclusion Criteria:

  • Age under 18 years or over 60.
  • Pregnant women
  • Allergy to iodine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748722

Locations
Israel
Tel-Aviv Medical Center
Tel-Aviv, Israel, 64239
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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

Publications:
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

Keywords provided by Tel-Aviv Sourasky Medical Center:
Breast reconstruction
Perforator flaps
CT Angiography

ClinicalTrials.gov processed this record on August 27, 2014