Clinical trial NCT00748722: Pre-Operative Imaging of Abdominal Wall Perforators Using CT Angiography
Official title: Pre-Operative Imaging of Abdominal Wall Perforators Using CT Angiography for DIEP Breast Reconstruction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Reconstruction
Keywords: Breast reconstruction
Perforator flaps
CT Angiography
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-09-09
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients, age 18-60 years eligible for lower abdominal 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: 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 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

Primary outcomes:
measure: 1 year from starting date
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Tel-Aviv Medical Center
Study officials:
affiliation: Tel Aviv Medical Center
name: Yoav Barnea, MD
role: STUDY_CHAIR
affiliation: Tel Aviv Medical Center
name: Arie Blachar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tel Aviv Medical Center
name: Eyal Gur, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rozen WM, Palmer KP, Suami H, Pan WR, Ashton MW, Corlett RJ, Taylor GI. The DIEA branching pattern and its relationship to perforators: the importance of preoperative computed tomographic angiography for DIEA perforator flaps. Plast Reconstr Surg. 2008 Feb;121(2):367-373. doi: 10.1097/01.prs.0000298313.28983.f4.
citation: Rozen WM, Phillips TJ, Ashton MW, Stella DL, Gibson RN, Taylor GI. Preoperative imaging for DIEA perforator flaps: a comparative study of computed tomographic angiography and doppler ultrasound. Plast Reconstr Surg. 2008 Jan;121(1 Suppl):1-8.