DUGi

Optimizing recovery: investigating the role of early postoperative mobilisation in free flaps surgery for lower leg reconstruction

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BACKGROUND: Loss of soft tissue in the lower leg presents a significant challenge for reconstruction. In the field of plastic surgery, free tissue transfer has become a common solution for large or complex soft tissue defects. Following free flap reconstruction, patients typically undergo a post-operative dangling protocol to gradually acclimatise the lower leg free flaps to increased venous pressure. However, the criteria for these dangling protocols vary between surgeons and centres and are often based on individual experience. Due to the lack of scientific evidence, there is no consensus on when to start mobilisation of the reconstructed lower leg. OBJECTIVES: The aim of this study is to compare the length of hospital stay after free flap lower leg reconstruction between patients undergoing early mobilisation (postoperative day 3) and those undergoing late mobilisation (postoperative day 10). Secondary objectives are to evaluate and compare the percentage of flap success, the incidence of complications, the need for rehabilitation and the direct economic costs between the two groups. DESIGN: This study is designed as a multicentre, prospective, randomized, open-label, parallel-group trial involving patients undergoing free flap lower leg reconstruction in three hospitals across Catalonia. METHODS: 140 participants undergoing free flap lower leg reconstructive surgery will be enrolled using a consecutive sampling method. Participants will be randomly assigned in a 1:1 ratio to the intervention group (early mobilization starting on postoperative day 3) and the control group (same protocol starting on day 10). The main outcome variable will be length of hospital stay. Flap success and complications will be evaluated during the hospital stay. Patients will be followed for 1 year, with periodic visits to evaluate flap success and to assess if rehabilitation is needed. After 1 year the economic direct costs will be calculated. All data on study variables and covariates will be collected and analysed to determine their statistical significance. The total duration of the study is estimated to be 5 years

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