Clinical trial · Observational
Mastectomy Reconstruction Outcomes Consortium (MROC) Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The MROC Study seeks to evaluate and compare from the patient's point of view the leading options for breast reconstruction after mastectomy. This study will help patients, physicians, payers and policy makers better understand the various surgeries available for breast reconstruction. Although many women choose reconstruction, the number of options as well as their pros and cons can make decision making difficult and stressful. From this research, we hope to learn more about what works best for patients undergoing these operations.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (8)
- label
- Expander/Implant
- description
- Patients receiving expander/implant breast reconstruction procedures.
- label
- Lat Dorsi
- description
- Patients receiving latissimus dorsi breast reconstructions with or without implant.
- label
- PTRAM
- description
- Patients receiving pedicle transverse rectus abdominis musculocutaneous (PTRAM)breast reconstruction.
- label
- FTRAM
- description
- Patients receiving free transverse rectus abdominis musculocutaneous (FTRAM.)
- label
- DIEP
- description
- Patients receiving deep inferior epigastric perforator (DIEP) breast reconstructions.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women who present themselves for reconstruction at one of 11 MROC centers * Women undergoing one of the following types of breast reconstruction after mastectomy: tissue expander/implant, LD flap (with, or without implant), PTRAM flap, FTRAM flap, DIEP flap, S-GAP flap, I-GAP flap or SIEA flap. * Immediate or delayed reconstruction * Unilateral or bilateral reconstructions. * Women receiving mastectomy for cancer prophylaxis, without history of breast cancer, will be eligible to participate. Exclusion Criteria: * Patients electing reconstruction following complications of breast augmentation, mastopexy (breast lift), or breast reduction will not be recruited for the study. * Procedures performed following previously failed attempts at breast reconstruction will be excluded from the study, due to potential confounding by these previous surgeries.
References
Publications (5)
- BACKGROUNDWilkins EG, Cederna PS, Lowery JC, Davis JA, Kim HM, Roth RS, Goldfarb S, Izenberg PH, Houin HP, Shaheen KW. Prospective analysis of psychosocial outcomes in breast reconstruction: one-year postoperative results from the Michigan Breast Reconstruction Outcome Study. Plast Reconstr Surg. 2000 Oct;106(5):1014-25; discussion 1026-7. doi: 10.1097/00006534-200010000-00010. PMID 11039373
- BACKGROUNDAlderman AK, Kuhn LE, Lowery JC, Wilkins EG. Does patient satisfaction with breast reconstruction change over time? Two-year results of the Michigan Breast Reconstruction Outcomes Study. J Am Coll Surg. 2007 Jan;204(1):7-12. doi: 10.1016/j.jamcollsurg.2006.09.022. Epub 2006 Nov 16. PMID 17189107
- BACKGROUNDAlderman AK, Wilkins EG, Kim HM, Lowery JC. Complications in postmastectomy breast reconstruction: two-year results of the Michigan Breast Reconstruction Outcome Study. Plast Reconstr Surg. 2002 Jun;109(7):2265-74. doi: 10.1097/00006534-200206000-00015. PMID 12045548
- BACKGROUNDRoth RS, Lowery JC, Davis J, Wilkins EG. Persistent pain following postmastectomy breast reconstruction: long-term effects of type and timing of surgery. Ann Plast Surg. 2007 Apr;58(4):371-6. doi: 10.1097/01.sap.0000239810.38137.84. PMID 17413877
- BACKGROUNDHu ES, Pusic AL, Waljee JF, Kuhn L, Hawley ST, Wilkins E, Alderman AK. Patient-reported aesthetic satisfaction with breast reconstruction during the long-term survivorship Period. Plast Reconstr Surg. 2009 Jul;124(1):1-8. doi: 10.1097/PRS.0b013e3181ab10b2. PMID 19568038