DIEP Flap Breast ReconstructionNCT01469494
Breast and Abdominal Related Morbidity of DIEP and SIEA Flaps
A study testing DIEP flap breast reconstruction and SIEA flap breast reconstruction in people with DIEP Flap Breast Reconstruction and SIEA Flap Breast Reconstruction, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- DIEP Flap Breast Reconstruction, SIEA Flap Breast Reconstruction
- What is being tested?
- DIEP flap breast reconstruction and SIEA flap breast reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female subject older than 18
- with satisfactory abdominal tissue for DIEP and SIEA flap reconstruction
- fluent in English
Who cannot join
- reconstruction planned using latissimus dorsi flap, gluteal artery perforator flap or tissue expansion
- suffer from neurological back problems
- suffer form inguinal hernias
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial Comparing Breast and Abdominal Related Morbidity of DIEP and SIEA Flaps
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.
Read the detailed 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.
- Being tested
- DIEP flap breast reconstruction, SIEA flap breast reconstruction
- Keywords
- 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
- Medical subject headings
- Fat Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIEP flap breast reconstructionProcedure or surgery
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.
SIEA flap breast reconstructionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| DIEP flap group | 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. Receives: Procedure: DIEP flap breast reconstruction |
| SIEA flap group | 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. Receives: Procedure: SIEA flap breast reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in objective isokinetic abdominal strength
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.
Measured: pre-operative (baseline), 3, 6 and 12 months post-operative
Secondary outcomes (7)
Breast-Q questionnaire
self-administered and validated.
Measured: pre-operative (baseline) and 3 and 12 months post-operative
Fat Necrosis
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.
Measured: 3 and 6 months post-operative
Seroma Rate and Drainage Volumes
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).
Measured: 1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op
Flap Loss
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)
Measured: 1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op
Abdominal Wound Breakdown
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)
Measured: 1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op
Intra-Operative Outcomes:
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.
Measured: Intra-operative
Clinical Abdominal Examination
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.
Measured: 1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startFeb 2012
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DIEP Flap Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 91 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Keeping Abreast Charity
- Responsible party
- Sponsor
- Investigators
- Blair R Peters, BSc, Principal investigator, University of Manitoba Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469494
- Sponsor's protocol ID
- B2011:120
- Status last verified
- Aug 2014
- First submitted
- 23 Oct 2011
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Selber JC, Fosnot J, Nelson J, Goldstein J, Bergey M, Sonnad S, Serletti JM. A prospective study comparing the functional impact of SIEA, DIEP, and muscle-sparing free TRAM flaps on the abdominal wall: Part II. Bilateral reconstruction. Plast Reconstr Surg. 2010 Nov;126(5):1438-1453. doi: 10.1097/PRS.0b013e3181ea42ed.
PubMed 21042100Selber JC, Nelson J, Fosnot J, Goldstein J, Bergey M, Sonnad SS, Serletti JM. A prospective study comparing the functional impact of SIEA, DIEP, and muscle-sparing free TRAM flaps on the abdominal wall: part I. unilateral reconstruction. Plast Reconstr Surg. 2010 Oct;126(4):1142-1153. doi: 10.1097/PRS.0b013e3181f02520.
PubMed 20885239Futter CM, Webster MH, Hagen S, Mitchell SL. A retrospective comparison of abdominal muscle strength following breast reconstruction with a free TRAM or DIEP flap. Br J Plast Surg. 2000 Oct;53(7):578-83. doi: 10.1054/bjps.2000.3427.
PubMed 11000074Blondeel N, Vanderstraeten GG, Monstrey SJ, Van Landuyt K, Tonnard P, Lysens R, Boeckx WD, Matton G. The donor site morbidity of free DIEP flaps and free TRAM flaps for breast reconstruction. Br J Plast Surg. 1997 Jul;50(5):322-30. doi: 10.1016/s0007-1226(97)90540-3.
PubMed 9245865Bonde CT, Lund H, Fridberg M, Danneskiold-Samsoe B, Elberg JJ. Abdominal strength after breast reconstruction using a free abdominal flap. J Plast Reconstr Aesthet Surg. 2007;60(5):519-23. doi: 10.1016/j.bjps.2006.07.003. Epub 2007 Jan 17.
PubMed 17399661
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing Breast and Abdominal Related Morbidity of DIEP and SIEA Flaps
- ClinicalTrials.gov ID
- NCT01469494
- Acronym / sponsor ID
- B2011:120
- Keywords
- DIEP flap, SIEA flap, breast reconstruction, objective isokinetic abdominal strength testing, fat necrosis, flap loss, seroma rate, abdominal wound breakdown
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Keeping Abreast Charity
- Study start
- Feb 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DIEP flap group | Active comparator | Procedure: DIEP flap breast reconstructionThe 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 group | Active comparator | Procedure: SIEA flap breast reconstructionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- female subject older than 18
- with satisfactory abdominal tissue for DIEP and SIEA flap reconstruction
- fluent in English
Key exclusion criteria (3 listed)
- reconstruction planned using latissimus dorsi flap, gluteal artery perforator flap or tissue expansion
- suffer from neurological back problems
- suffer form inguinal hernias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DIEP flap breast reconstructionDIEP 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. | Procedure or surgery | DIEP flap group |
| SIEA flap breast reconstructionThe 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. | Procedure or surgery | SIEA flap group |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Background: PubMed 21042100Selber JC, Fosnot J, Nelson J, Goldstein J, Bergey M, Sonnad S, Serletti JM. A prospective study comparing the functional impact of SIEA, DIEP, and muscle-sparing free TRAM flaps on the abdominal wall: Part II. Bilateral reconstruction. Plast Reconstr Surg. 2010 Nov;126(5):1438-1453. doi: 10.1097/PRS.0b013e3181ea42ed.
- Background: PubMed 20885239Selber JC, Nelson J, Fosnot J, Goldstein J, Bergey M, Sonnad SS, Serletti JM. A prospective study comparing the functional impact of SIEA, DIEP, and muscle-sparing free TRAM flaps on the abdominal wall: part I. unilateral reconstruction. Plast Reconstr Surg. 2010 Oct;126(4):1142-1153. doi: 10.1097/PRS.0b013e3181f02520.
- Background: PubMed 11000074Futter CM, Webster MH, Hagen S, Mitchell SL. A retrospective comparison of abdominal muscle strength following breast reconstruction with a free TRAM or DIEP flap. Br J Plast Surg. 2000 Oct;53(7):578-83. doi: 10.1054/bjps.2000.3427.
- Background: PubMed 9245865Blondeel N, Vanderstraeten GG, Monstrey SJ, Van Landuyt K, Tonnard P, Lysens R, Boeckx WD, Matton G. The donor site morbidity of free DIEP flaps and free TRAM flaps for breast reconstruction. Br J Plast Surg. 1997 Jul;50(5):322-30. doi: 10.1016/s0007-1226(97)90540-3.
- Background: PubMed 17399661Bonde CT, Lund H, Fridberg M, Danneskiold-Samsoe B, Elberg JJ. Abdominal strength after breast reconstruction using a free abdominal flap. J Plast Reconstr Aesthet Surg. 2007;60(5):519-23. doi: 10.1016/j.bjps.2006.07.003. Epub 2007 Jan 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blair R Peters, BSc principal investigator
University of Manitoba Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIEP flap breast reconstruction and SIEA flap breast reconstruction in people with DIEP Flap Breast Reconstruction and SIEA Flap Breast Reconstruction, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in objective isokinetic abdominal strength (time frame: pre-operative (baseline), 3, 6 and 12 months post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01469494, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.