Clinical trial · Observational
Outcomes After Perforator Flap Reconstruction for Breast Reconstruction and/or Lymphedema Treatment
- 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 goal of this prospective, observational study is to investigate the clinical, psychosocial, and patient satisfaction outcomes of patients who undergo perforator flap reconstruction for breast reconstruction and/or vascularized lymph node transfer (VLNTx) for the treatment of lymphedema. The investigators hypothesize that (1) perforator flap breast reconstruction will result in excellent clinical, psychosocial, and patient satisfaction outcomes compared to non-perforator flap breast reconstruction; (2) perforator flap breast reconstruction is associated with less persistent postsurgical pain than other forms of breast reconstruction, even after controlling for major cofactors, such as the extent of auxiliary lymph node dissection and the use of radiation therapy; (3) perforator flap reconstruction for the treatment of Lymphedema (i.e., VLNTx ) will result in the reduction of symptoms and complications of lymphedema.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acquired Lymphedema | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Congenital Lymphedema | — | UNRESOLVED | — |
| Hereditary Breast/Ovarian Cancer (brca1, brca2) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Perforator Flap Breast Reconstruction | Procedure | — | UNRESOLVED |
| Vascularized Lymph Node Transfer | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Perforator Flap Breast Reconstruction
- description
- Patients who undergo perforator flap breast reconstruction with or without concomitant vascularized lymph node transfer
- interventionNames
- Procedure: Perforator Flap Breast Reconstruction
- Procedure: Vascularized Lymph Node Transfer
- label
- Vascularized Lymph Node Transfer
- description
- Patients who undergo perforator flap vascularized lymph node transfer with or without concomitant perforator flap breast reconstruction
- interventionNames
- Procedure: Perforator Flap Breast Reconstruction
- Procedure: Vascularized Lymph Node Transfer
Primary outcomes (1)
- measure
- Change in BreastQ Questionnaire and Lymphedema Severity Score
- timeFrame
- Baseline and 6 months after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Undergoing perforator flap surgery for breast reconstruction and/or vascularized lymph node transfer for treatment of lymphedema Exclusion Criteria: * Pregnant * unable to read
References
Publications (5)
- BACKGROUNDMassey MF, Spiegel AJ, Levine JL, Craigie JE, Kline RM, Khoobehi K, Erhard H, Greenspun DT, Allen RJ Jr, Allen RJ Sr; Group for the Advancement of Breast Reconstruction. Perforator flaps: recent experience, current trends, and future directions based on 3974 microsurgical breast reconstructions. Plast Reconstr Surg. 2009 Sep;124(3):737-751. doi: 10.1097/PRS.0b013e3181b17a56. PMID 19730293
- BACKGROUNDGartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568. PMID 19903919
- BACKGROUNDDayangac M, Makay O, Yeniay L, Aynaci M, Kapkac M, Yilmaz R. Precipitating factors for lymphedema following surgical treatment of breast cancer: implications for patients undergoing axillary lymph node dissection. Breast J. 2009 Mar-Apr;15(2):210-1. doi: 10.1111/j.1524-4741.2009.00703.x. No abstract available. PMID 19292814
- BACKGROUNDBecker C, Assouad J, Riquet M, Hidden G. Postmastectomy lymphedema: long-term results following microsurgical lymph node transplantation. Ann Surg. 2006 Mar;243(3):313-5. doi: 10.1097/01.sla.0000201258.10304.16. PMID 16495693
- BACKGROUNDRockson SG, Rivera KK. Estimating the population burden of lymphedema. Ann N Y Acad Sci. 2008;1131:147-54. doi: 10.1196/annals.1413.014. PMID 18519968