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Background: A common complication after a DIEP flap reconstruction is the occurrence of fat necrosis due to inadequate flap perfusion zones. Intraoperative identification of ischemic zones in the DIEP flap could be optimized using indocyanine green near-infrared fluorescence angiography (ICG-NIR-FA). This randomized controlled trial aims to determine whether intraoperative ICG-NIR-FA for the assessment of DIEP flap perfusion decreases the occurrence of fat necrosis. Design/methods: This article describes the protocol of a Dutch multicenter randomized controlled clinical trial: the FAFI-trial. Females who are electively scheduled for autologous breast reconstruction using DIEP or muscle-sparing transverse rectus abdominis muscle (msTRAM) flaps are included. A total of 280 patients will be included in a 1:1 ratio between both study arms. In the intervention arm, the intraoperative assessment of flap perfusion will be based on both regular clinical parameters and ICG-NIR-FA. The control arm consists of flap perfusion evaluation only through the regular clinical parameters, while ICG-NIR-FA images are obtained during surgery for which the surgeon is blinded. The main study endpoint is the difference in percentage of clinically relevant fat necrosis between both study arms, evaluated two weeks and three months after reconstruction. Conclusion: The FAFI-trial, a Dutch multicenter randomized controlled clinical trial, aims to investigate the clinical added value of intraoperative use of standardized ICG-NIR-FA for assessment of DIEP/msTRAM flap perfusion in the reduction of fat necrosis. Clinical trial registration number: NCT05507710; NL 68623.058.18.
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INTRODUCTION: This study aimed to evaluate complication rates, patient satisfaction, and cosmetic outcomes after oncoplastic breast-conserving surgery (OPS). Furthermore, outcome differences between volume displacement and volume replacement techniques and the effect of postoperative complications on outcomes were evaluated. METHODS: This was a prospective single-center study addressing patients who underwent OPS from 2017 to 2020. The BREAST-Q was used to measure patient satisfaction, and cosmetic outcomes were assessed by patient self-evaluation and panel evaluation based on medical photographs. RESULTS: A total of 75 patients were included. The overall complication rate was 18.7%, of which 4% required invasive interventions. Median BREAST-Q scores ranged from 56 to 100 and cosmetic outcomes were scored good to excellent in 60-86%. No differences in complications were observed between volume replacement and volume displacement techniques. Following volume displacement techniques, patients-reported higher BREAST-Q scores for the domain "physical well-being of the chest" and lower cosmetic outcomes scores for "mammary symmetry." Patients with complications scored significantly lower on several domains of the BREAST-Q and in various cosmetic outcome categories. CONCLUSION: In this cohort, an overall complication rate of 18.7% was observed. Patients were generally satisfied, and most cosmetic outcomes were good to excellent. Volume displacement or replacement techniques were performed for different indications and generally showed comparable results. Expected differences in physical discomfort and symmetry between both techniques were observed. In addition, the occurrence of complications resulted in lower patient satisfaction and cosmetic outcomes. These findings emphasize the importance of thorough preoperative counselling.
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Neoplasias da Mama , Mamoplastia , Humanos , Feminino , Satisfação do Paciente , Mamoplastia/efeitos adversos , Mamoplastia/métodos , Estudos Prospectivos , Mastectomia , Mastectomia Segmentar/efeitos adversos , Mastectomia Segmentar/métodos , Neoplasias da Mama/cirurgiaRESUMO
BACKGROUND: One of the complications of free flap breast reconstruction is the occurrence of skin and fat necrosis. Intra-operative use of near-infrared (NIR) fluorescence imaging with Indocyanine Green (ICG) has the potential to predict these complications. In this study, the quantification of the fluorescence intensity measured in free flap breast reconstruction was performed to gain insight into the perfusion patterns observed with ICG NIR fluorescence imaging. METHODS: ICG NIR fluorescence imaging was performed in patients undergoing free flap breast reconstruction following mastectomy. After completion of the arterial and venous anastomosis, 7.5 mg ICG was administered intravenously. The fluorescence intensity over time was recorded using the Quest Spectrum Platform®. Four regions of interest (ROI) were selected based on location and interpretation of the NIR fluorescence signal: (1) The perforator, (2) normal perfusion, (3) questionable perfusion, and (4) low perfusion. Time-intensity curves were analyzed, and two parameters were extracted: Tmax and Tmax slopes. RESULTS: Successful ICG NIR fluorescence imaging was performed in 13 patients undergoing 17 free flap procedures. Region selection included 16 perforators, 17 normal perfusions, 8 questionable perfusions, and 5 low perfusion ROIs. Time-intensity curves of the perforator ROIs were comparable to the ROIs of normal perfusion and demonstrated a fast inflow. No outflow was observed for the ROIs with questionable and low perfusion. CONCLUSION: This study provides insight into the perfusion patterns observed with ICG NIR fluorescence imaging in free flap breast reconstruction. Future studies should correlate quantitative parameters with clinical perfusion assessment and outcome.
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Neoplasias da Mama , Retalhos de Tecido Biológico , Mamoplastia , Feminino , Humanos , Verde de Indocianina , Mamoplastia/métodos , Mastectomia/métodos , Imagem ÓpticaRESUMO
The current case presents a patient who was admitted to our hospital with the diagnosis of cellulitis of the right groin. In the following days, the patient's condition deteriorated and developed a septic shock. Exploration in the operating room showed a necrotising fasciitis of the adductor muscles, with an infected sebaceous cyst in the inguinal crest as port d'entrée. After extensive surgical debridement, antibiotic therapy, haemodynamic and respiratory support, the patient recovered. Necrotising fasciitis is a rare but very lethal condition, which necessitates aggressive surgical therapy and antibiotic support. The current case report is the first report to show a necrotising fasciitis due to an infected sebaceous cyst.