Pre-Operative Imaging of Abdominal Wall Perforators Using CT Angiography

Breast Reconstruction Clinical Trial

— DIEP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00748722
• Other study ID #: TASMC-08-YB-0181-CTIL
• Status: Active, not recruiting
• Phase: N/A
• First received: July 15, 2008
• Last updated: September 7, 2008
• Start date: September 2008
• Est. completion date: August 2009

Study information

• Verified date: September 2008
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Reconstruction

Intervention

Device:
• CT Angiography
Injection of contrast material (iodine)

Locations

Country	Name	City	State
Israel	Tel-Aviv Medical Center	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (2)

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 Fe — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1 year from starting date		1 year	No