Pre-Operative Imaging of Abdominal Wall Perforators Using CT Angiography - Tabular View

Tracking Information

First Received Date ^ICMJE

July 15, 2008

Last Updated Date

September 7, 2008

Start Date ^ICMJE

September 2008

Estimated Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

1 year from starting date [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00748722 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Pre-Operative Imaging of Abdominal Wall Perforators Using CT Angiography

Official Title ^ICMJE

Pre-Operative Imaging of Abdominal Wall Perforators Using CT Angiography for DIEP Breast Reconstruction

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.

Detailed Description

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 Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case-Only, Prospective

Condition ^ICMJE

Breast Reconstruction

Intervention ^ICMJE

Device: CT Angiography

Study Arms / Comparison Groups

Female patients, age 18-60 years, suitable for breast reconstruction using the lower abdominal tissue.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2009

Estimated Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00748722

Responsible Party

Yoav Barnea, MD, Tel Aviv Medical Center

Study ID Numbers ^ICMJE

TASMC-08-YB-0181-CTIL

Study Sponsor ^ICMJE

Tel-Aviv Sourasky Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Tel-Aviv Sourasky Medical Center

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP