Pre-Operative Imaging of Abdominal Wall Perforators Using CT Angiography

NCT00748722 | Unknown DMC

• 1 other identifier: TASMC-08-YB-0181-CTIL
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Reconstruction

Keywords

Breast reconstruction; Perforator flaps; CT Angiography

Outcome Measures

Primary Outcomes (1)

• 1 year from starting date

  1 year

Study Arms (1)

1

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

Device: CT Angiography

Interventions

CT Angiography DEVICE

Injection of contrast material (iodine)

Also known as: Iodine

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Age under 18 years or over 60.
• Pregnant women
• Allergy to iodine

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel-Aviv Medical Center

Tel Aviv, 64239, Israel

Location

Related 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 Feb;121(2):367-373. doi: 10.1097/01.prs.0000298313.28983.f4.

  PMID: 18300951 RESULT

• 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.

  PMID: 18213740 RESULT

MeSH Terms

Interventions

Computed Tomography Angiography; Thyroid Function Tests

Intervention Hierarchy (Ancestors)

Tomography, X-Ray Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography; Diagnostic Techniques, Endocrine

Study Officials

• Yoav Barnea, MD

  Tel Aviv Medical Center

  STUDY CHAIR

• Arie Blachar, MD

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

• Eyal Gur, MD

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 15, 2008
• First Posted: September 9, 2008
• Study Start: September 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: September 9, 2008

Record last verified: 2008-09

Locations

IL (1)