CompletedNot Applicable

Breast and Abdominal Related Morbidity of DIEP and SIEA Flaps

Canada91 participantsStarted 2012-02

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in objective isokinetic abdominal strength

Timeframe: pre-operative (baseline), 3, 6 and 12 months post-operative

Trial details

NCT IDNCT01469494

SponsorUniversity of Manitoba

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12

View on ClinicalTrials.gov More DIEP Flap Breast Reconstruction trials