Overview

This trial is active, not recruiting.

Conditions diep flap breast reconstruction, siea flap breast reconstruction
Treatments diep flap breast reconstruction, siea flap breast reconstruction
Sponsor University of Manitoba
Collaborator Keeping Abreast Charity
Start date February 2012
End date December 2015
Trial size 91 participants
Trial identifier NCT01469494, B2011:120

Summary

The Deep Inferior Epigastric Perforator flap (DIEP) is the current standard of care in breast reconstruction. The newer Superficial Inferior Epigastric Artery flap (SIEA) is felt to be an improvement as it does not damage the abdominal wall. The SIEA unfortunately has smaller vessels which put the flap at a higher risk of developing flap loss and fat necrosis. The uncertainty regarding the tradeoffs inherent in the choice of procedure has not been resolved. As such the investigators aim to perform a randomized single blinded trial to evaluate the abdominal and breast related morbidity associated with DIEP and SIEA flaps.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
The standard of care for the patient population is the DIEP or SIEA flap breast reconstruction. Currently the single operating surgeon in the study will always try to perform a SIEA flap reconstruction. If the anatomy does not allow it he will convert to a DIEP flap. The majority of breast surgeons in North America will generally perform a DIEP flap initially. The proposed study does not alter the standard of care received.
diep flap breast reconstruction
DIEP stands for deep inferior epigastric perforator. This is the name of the main blood vessel that runs through the abdominal tissue that will be used to reconstruct the breast. In DIEP flap reconstruction, only skin, fat, and blood vessels are removed from the lower belly (the abdomen between the waist and hips). No muscle is removed.
(Active Comparator)
The standard of care for the patient population is the DIEP or SIEA flap breast reconstruction. Currently the single operating surgeon in the study will always try to perform a SIEA flap reconstruction. If the anatomy does not allow it he will convert to a DIEP flap. The majority of breast surgeons in North America will generally perform a DIEP flap initially. The proposed study does not alter the standard of care received.
siea flap breast reconstruction
The SIEA flap is very similar to the DIEP flap procedure. Both techniques use the lower abdominal skin and fatty tissue to reconstruct a natural, soft breast following mastectomy. The main difference between the SIEA flap and the DIEP flap is the artery used to supply blood flow to the new breast. The SIEA blood vessels are found in the fatty tissue just below skin whereas the DIEP blood vessels run below and within the abdominal muscle (making the surgery more technically challenging). While the surgical preparation is slightly different, both procedures spare the abdominal muscle and only use the patient's skin and fat to reconstruct the breast.

Primary Outcomes

Measure
Change in objective isokinetic abdominal strength
time frame: pre-operative (baseline), 3, 6 and 12 months post-operative

Secondary Outcomes

Measure
Breast-Q questionnaire
time frame: pre-operative (baseline) and 3 and 12 months post-operative
Fat Necrosis
time frame: 3 and 6 months post-operative
Seroma Rate and Drainage Volumes
time frame: 1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op
Flap Loss
time frame: 1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op
Abdominal Wound Breakdown
time frame: 1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op
Intra-Operative Outcomes:
time frame: Intra-operative
Clinical Abdominal Examination
time frame: 1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - female subject older than 18 - with satisfactory abdominal tissue for DIEP and SIEA flap reconstruction - fluent in English Exclusion Criteria: - reconstruction planned using latissimus dorsi flap, gluteal artery perforator flap or tissue expansion - suffer from neurological back problems - suffer form inguinal hernias

Additional Information

Official title A Randomized Clinical Trial Comparing Breast and Abdominal Related Morbidity of DIEP and SIEA Flaps
Principal investigator Blair R Peters, BSc
Description A blinded, randomized, prospective clinical trial is being performed involving Manitoban women over 18 years undergoing unilateral or bilateral breast reconstruction. Women were originally randomized 50/50 to either the DIEP or SIEA group. Due to only about 60-70% of patients randomized to the SIEA group actually receiving the SIEA procedure, the weight of the randomization has now been changed to 70/30 (SIEA/DIEP) for the remainder of the study (approx. 40/110 recruited patients waiting for their OR). Objective isokinetic abdominal strength testing is being done pre-operatively and 3, 6 and 12 months post-operatively. A self-administered validated abdominal wall and breast outcome questionnaire (Breast-Q) is also given preoperatively and at 3 and 12 months postoperatively in . Secondary outcomes measured include: fat necrosis, abdominal wound breakdown, flap loss and seroma rate. Fat necrosis is detected using ultrasonography. Abdominal wound breakdown is measured using calipers. Seroma rates are tabulated and drainage volumes measured. Statistical analyses include a combination of parametric and non-parametric tests.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by University of Manitoba.