Breast and Abdominal Related Morbidity of DIEP and SIEA Flaps

NCT01469494 | Completed DMC

• 1 other identifier: B2011:120
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (7)

• Breast-Q questionnaire

  pre-operative (baseline) and 3 and 12 months post-operative

• Fat Necrosis

  3 and 6 months post-operative

• Seroma Rate and Drainage Volumes

  1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op

• Flap Loss

  1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op

• Abdominal Wound Breakdown

  1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op

Study Arms (2)

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.

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.

Procedure: SIEA flap breast reconstruction

Interventions

DIEP flap breast reconstruction PROCEDURE

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.

DIEP flap group

SIEA flap breast reconstruction PROCEDURE

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.

SIEA flap group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female subject older than 18
• with satisfactory abdominal tissue for DIEP and SIEA flap reconstruction
• fluent in English

You may not qualify if:

• reconstruction planned using latissimus dorsi flap, gluteal artery perforator flap or tissue expansion
• suffer from neurological back problems
• suffer form inguinal hernias

Sponsors & Collaborators

• University of Manitoba: lead
• Keeping Abreast Charity: collaborator

Study Sites (1)

Health Sciences Centre

Winnipeg, Manitoba, R3A 149, Canada

Location

Related Publications (5)

• 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.

  PMID: 21042100 BACKGROUND

• Selber 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.

  PMID: 20885239 BACKGROUND

• Futter 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.

  PMID: 11000074 BACKGROUND

• Blondeel 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.

  PMID: 9245865 BACKGROUND

• Bonde 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.

  PMID: 17399661 BACKGROUND

MeSH Terms

Conditions

Fat Necrosis

Condition Hierarchy (Ancestors)

Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Blair R Peters, BSc

  University of Manitoba Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2011
• First Posted: November 10, 2011
• Study Start: February 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 6, 2018

Record last verified: 2014-08

Locations

CA (1)