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

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ClinicalTrials.gov Identifier: NCT00748722
Recruitment Status : Unknown
Verified September 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : September 9, 2008
Last Update Posted : September 9, 2008
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center

Brief Summary:

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 or disease Intervention/treatment
Breast Reconstruction Device: CT Angiography

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.


Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pre-Operative Imaging of Abdominal Wall Perforators Using CT Angiography for DIEP Breast Reconstruction
Study Start Date : September 2008
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Iodine

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 1 year from starting date [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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