Protocol for a multicentre, prospective, cohort study to investigate patient satisfaction and quality of life after immediate breast reconstruction in Japan: the SAQLA study.

INTRODUCTION: The aim of breast reconstruction (BR) is to improve patients' health-related quality of life (HRQOL). Therefore, measuring patient-reported outcomes (PROs) would clarify the value and impact of BR on a patient's life and thus would provide evidence-based information to help decision-making. The Satisfaction and Quality of Life After Immediate Breast Reconstruction study aimed to investigate satisfaction and HRQOL in Japanese patients with breast cancer who undergo immediate breast reconstruction (IBR). METHODS AND ANALYSIS: This ongoing prospective, observational multicentre study will assess 406 patients who had unilateral breast cancer and underwent mastectomy and IBR, and were recruited from April 2018 to July 2019. All participants were recruited from seven hospitals: Okayama University Hospital, Iwate Medical University Hospital, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Showa University Hospital, University of Tsukuba Hospital, Osaka University Hospital and Yokohama City University Medical Center. The patients will be followed up for 36 months postoperatively. The primary endpoint of this study will be the time-dependent changes in BREAST-Q satisfaction with breast subscale scores for 12 months after reconstructive surgery, which will be collected via an electronic PRO system. ETHICS AND DISSEMINATION: This study will be performed in accordance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects published by Japan's Ministry of Education, Science and Technology and the Ministry of Health, Labour and Welfare, the modified Act on the Protection of Personal Information and the Declaration of Helsinki. This study protocol was approved by the institutional ethics committee at the Okayama University Graduate School of Medicine, Dentistry, on 2 February 2018 (1801-039) and all other participating sites. The findings of this trial will be submitted to an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: UMIN000032177.

Efficacy of distraction osteogenesis for mandibular reconstruction in previously irradiated areas: clinical experiences.

The efficacy of distraction osteogenesis in an irradiated area is controversial, although this procedure is now widely used in the field of craniomaxillofacial surgery. We report the clinical results from 4 patients with mandibular defects treated by lengthening of the irradiated mandibles. All patients had a mandibular defect caused by ablation of a malignant tumor. They had undergone radiotherapy at a total dose of 30 to 50 Gy to the surgical site after tumorectomy. Distraction osteogenesis was used as the secondary reconstruction method in 6 sites of the remaining irradiated mandibles and in 1 site of the transferred vascularized scapula after radiotherapy. The transported segment was obtained by corticotomy with an initial gap of 0 to 2 mm, and internal extension plates were used. Distraction was commenced after a latency period of 7 to 10 days and performed at the rate of 0.25 to 1.0 mm/d. The total amount of distraction and consolidation periods ranged from 15 to 25 mm and 120 to 193 days, respectively. In 5 of the 6 sites in the remaining irradiated mandibles, satisfactory bone formation in the distraction gap was observed, although a fracture after new bone formation was observed in 1 site. Fibrous callus formation was observed in 1 irradiated site only, and satisfactory results were obtained in another site of transferred vascularized scapula in the same patient. From these experiences, we believe that distraction may provide a reconstruction option for mandibular defects even under irradiated conditions because the procedure is simple and less invasive.

Reconstruction of a severe maxillofacial deformity after tumorectomy and irradiation using distraction osteogenesis and LeFort I osteotomy before vascularized bone graft.

We present the successful reconstruction of a large mandibular defect with a severe maxillofacial deformity after malignant tumor resection and irradiation. The patient was a 16-year-old boy with a defect in the left mandible, which extended from the mandibular body to the condylar process and hypoplasia of the maxillozygomatic complex on the left side as a result of ablation and radiotherapy of a grown rhabdomyosarcoma in the left infratemporal fossa at the age of 10. We planned a two-stage reconstruction because of his wide mandibular defect and hypoplasia. LeFort I type osteotomy to correct the maxillary declination was combined with mandibular lengthening to decrease the width of the defect in the first stage. New bone formation was confirmed at the distraction site 4 months after surgery, and the second stage was performed. A free latissimus dorsi myocutaneous flap with a vascularized scapula and rib was transferred to reconstruct the ramus of the mandible, zygomatic arch, and soft tissues. This procedure resulted in satisfactory results. In conclusion, the combination of distraction osteogenesis and microsurgical bone transplantation facilitated the straightforward reconstruction of a three-dimensional deformity with huge bony defects. We think that this combined surgical procedure will become a favorable option in the treatment of severe maxillomandibular deformities with bone defects.