Breast and Abdominal Related Morbidity of DIEP and SIEA Flaps
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ClinicalTrials.gov Identifier: NCT01469494 |
Recruitment Status
: Unknown
Verified August 2014 by University of Manitoba.
Recruitment status was: Active, not recruiting
First Posted
: November 10, 2011
Last Update Posted
: March 24, 2015
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Condition or disease | Intervention/treatment | Phase |
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DIEP Flap Breast Reconstruction SIEA Flap Breast Reconstruction | Procedure: DIEP flap breast reconstruction Procedure: SIEA flap breast reconstruction | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 91 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Clinical Trial Comparing Breast and Abdominal Related Morbidity of DIEP and SIEA Flaps |
Study Start Date : | February 2012 |
Estimated Primary Completion Date : | December 2015 |
Estimated Study Completion Date : | January 2016 |
Arm | Intervention/treatment |
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Active Comparator: DIEP flap group
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.
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Procedure: 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.
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Active Comparator: SIEA flap group
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.
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Procedure: 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. |
- Change in objective isokinetic abdominal strength [ Time Frame: pre-operative (baseline), 3, 6 and 12 months post-operative ]Strength of the abdominal muscles and the back extensors is being objectively measured by isokinetic strength testing on an isokinetic dynamometer (Biodex System III with dual position back extension/flexion attachment). The abdominal strength testing is being performed pre-operatively and at 3, 6 and 12 months post-op. Objective measurements are used to address the strength of the rectus abdominus muscle and all data is collected by personnel at PanAn Clinic who have been trained in the required techniques. The technician performing the assessments is blinded to the type of breast reconstruction that has been performed.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01469494
Canada, Manitoba | |
Health Sciences Centre | |
Winnipeg, Manitoba, Canada, R3A 149 |
Principal Investigator: | Blair R Peters, BSc | University of Manitoba Faculty of Medicine |
Publications:
Responsible Party: | University of Manitoba |
ClinicalTrials.gov Identifier: | NCT01469494 History of Changes |
Other Study ID Numbers: |
B2011:120 |
First Posted: | November 10, 2011 Key Record Dates |
Last Update Posted: | March 24, 2015 |
Last Verified: | August 2014 |
Keywords provided by University of Manitoba:
DIEP flap SIEA flap breast reconstruction objective isokinetic abdominal strength testing fat necrosis |
flap loss seroma rate abdominal wound breakdown Breast-Q abdominal wall outcome questionnaire |
Additional relevant MeSH terms:
Diclofenac hydroxyethylpyrrolidine Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents |