Clinical Trial: Breast and Abdominal Related Morbidity of DIEP and SIEA Flaps

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomized Clinical Trial Comparing Breast and Abdominal Related Morbidity of DIEP and SIEA Flaps

Brief 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.

Detailed Summary: 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.
Sponsor: University of Manitoba

Current Primary Outcome: Change in objective isokinetic abdominal strength [ Time Frame: pre-operative (baseline), 3, 6 and 12 months post-operative ]

Original Primary Outcome: Change in objective isokinetic abdominal strength testing [ Time Frame: pre-operative (baseline), 3, 6 and 12 months post-operative ]

Current Secondary Outcome:

• Breast-Q questionnaire [ Time Frame: pre-operative (baseline) and 3 and 12 months post-operative ]
  self-administered and validated.
• Fat Necrosis [ Time Frame: 3 and 6 months post-operative ]
  Will be detected using ultrasonography. Ultrasound characteristics of fat necrosis are quite variable and reflect the degree of fibrosis. Assessment for fat necrosis will take place both 3 and 6 months post-operatively by another plastic surgeon who is therefore blinded to the procedure performed.
• 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 ]
  Rates will be tabulated and drainage volumes will be measured during regular followup appointments with the care team (1 week post-op, 2 weeks post-op, 6-8 weeks post-op, 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 ]
  Partial flap loss defined as tissue loss greater than 10 percent of the flap or fat necrosis greater than 5cm in diameter. Total flap loss will also be assessed. These assessments will be done during regular followup appointments with the care team (1 week post-op, 2 weeks post-op, 6-8 weeks post-op, 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 ]
  Defined as necrosis or wound dehiscence resulting in an open wound. Will be assessed with calipers. This will be assessed during regular followup appointments with the care team (1 week post-op, 2 weeks post-op, 6-8 weeks post-op, 3 months post-op)
• Intra-Operative Outcomes: [ Time Frame: Intra-operative ]
  Intra-operative data is also being collected with the intention of using it to identify any variables of the DIEP and SIEA procedures associated with the breast and abdominal outcomes being assessed in the study. The intra-operative data being collected includes whether or not the superficial inferior epigastric vessels are present in both treatment groups. If the vessels are present, it is recorded whether or not they are of sufficient calibre to support an SIEA flap. This information is to show how many patients enrolled would be candidates to receive the SIEA procedure had they not been randomized to a treatment group pre-operatively. The size of the SIEA/DIEA at the femoral artery/external iliac artery and the size of the SIEV/DIEV at the femoral vein/external iliac vein is also recorded, along with the size of the venous coupler used to anastomose the donor and recipient vein. Other intra-op. data is being collected as well.
• Clinical Abdominal Examination [ Time Frame: 1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op ]
  Patients are examined in the plastic surgery department both in the supine and upright positions for asymmetric positioning of the umbilicus, abdominal wall asymmetry, lower abdominal bulging, hernias and abdominal wound breakdown (post- operatively using calipers). Any pre-existing scars are also noted to see if this affects complication rates. This clinical examination is completed pre-operatively by the operating surgeon and during the regular follow-up appointments (1 week, 2 weeks, 6-8 weeks, 3 months post-op) by the head nurse, who has been instructed to do these assessments on every patient receiving DIEP or SIEA breast reconstruction. She therefore, does not know who is actually enrolled in the study.

Original Secondary Outcome:

• Abdominal Wall Outcome Questionnaire [ Time Frame: pre-operative (baseline) and 6 months post-operative ]
  self-administered, validated.
• Breast-Q questionnaire [ Time Frame: pre-operative (baseline) and post-operative ]
  self-administered and validated.
• Fat Necrosis [ Time Frame: 3 and 6 months post-operative ]
  Will be detected using ultrasonography. Ultrasound characteristics of fat necrosis are quite variable and reflect the degree of fibrosis. Assessment for fat necrosis will take place both 3 and 6 months post-operatively.
• Seroma Rate [ Time Frame: 1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op ]
  Rates will be tabulated and drainage volumes will be measured during regular followup appointments with the care team (1 week post-op, 2 weeks post-op, 6-8 weeks post-op, 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 ]
  Partial flap loss defined as tissue loss greater than 10 percent of the flap or fat necrosis greater than 5cm in diameter. Total flap loss will also be assessed. These assessments will be done during regular followup appointments with the care team (1 week post-op, 2 weeks post-op, 6-8 weeks post-op, 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 ]
  Defined as necrosis or wound dehiscence resulting in an open wound. Will be assessed with calipers. This will be assessed during regular followup appointments with the care team (1 week post-op, 2 weeks post-op, 6-8 weeks post-op, 3 months post-op)

Dates:
Date Received: October 23, 2011
Date Started: February 2012
Date Completion: January 2016
Last Updated: March 19, 2015
Last Verified: August 2014