Background: There is little high-quality scientific evidence identifying the best and safest methods for delayed breast reconstruction, with most previous studies retrospective in nature. The primary aim was to compare early complication rates for two different breast-reconstructive methods in radiated and non-radiated patients, using a validated scale. The secondary aim was to identify predictors for complications. Materials and methods: This study represents a clinical, randomized, prospective trial (ClinicalTrials.Gov identifier: NCT03963427), where the patients were divided into two study arms: non-radiated and radiated. In the non-radiated arm, patients were randomized to a one-stage lateral thoracodorsal flap with an implant or two-stage expander reconstruction. In the radiated arm, patients were randomized to a latissimus dorsi reconstruction combined with an implant or deep inferior epigastric artery perforator (DIEP) reconstruction. All adverse events were classified according to ClavieneDindo and summarization of overall morbidity was performed by calculating the Comprehensive Complication Index score. The study was conducted from 2008 to 2020. Results: The complication frequencies were similar for the two surgical methods within each arm. In the non-radiated arm, risk factors for any complication were any comorbidities, and in the radiated arm, factors were a high body mass index and a contralateral operation. Conclusions: The usage of the Clavien-Dindo scale in reconstructive surgery is feasible, but further validation is needed. In non-radiated patients, the frequencies of short-term complications were similar for lateral thoracodorsal flap and expander reconstruction, whereas in radiated patients, they were similar for DIEP and latissimus dorsi. The complication profile of the methods varied.

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