TY - JOUR
T1 - Is dangling of the lower leg after a free flap reconstruction necessary? Study protocol for a large multicenter randomized controlled study
AU - Krijgh, David D.
AU - Teunis, Teun
AU - Schellekens, Pascal P. A.
AU - Mureau, Marc A. M.
AU - Luijsterburg, Antonius J. M.
AU - Tempelman, Tallechien M. T.
AU - van Der Beek, Eva S. J.
AU - Maarse, Wiesje
AU - Coert, J. Henk
PY - 2019/9/11
Y1 - 2019/9/11
N2 - Background Within the field of plastic surgery, free tissue transfer is common practice for knee and lower leg defects. Usually, after such free flap reconstruction, patients undergo a dangling protocol in the postoperative phase. A dangling protocol is designed to gradually subject the free flap to increased venous pressure resulting from gravitational forces. Worldwide there are multiple variations of dangling protocols. However, there is no evidence available in the literature that supports the use of a dangling protocol. Methods This is a multicenter randomized controlled trial that includes patients with a free flap lower leg reconstruction. The primary outcome is to assess whether a no-dangling protocol is not inferior to a dangling protocol, in terms of proportion of partial flap loss, 6 months after surgery. Secondary objectives are to identify differences in major and minor complications, length of stay, and costs, and to objectify blood gaseous changes during dangling. Furthermore, at 2 years we will assess difference in physical function, infection rates, and osseous union rates. Discussion The primary outcome of this study will give a more decisive answer to the question of whether a dangling protocol is necessary after a free flap reconstruction of the lower leg. The secondary outcomes of this study will provide a better insight into the physical functions, infection rates, and union rates in these patients.
AB - Background Within the field of plastic surgery, free tissue transfer is common practice for knee and lower leg defects. Usually, after such free flap reconstruction, patients undergo a dangling protocol in the postoperative phase. A dangling protocol is designed to gradually subject the free flap to increased venous pressure resulting from gravitational forces. Worldwide there are multiple variations of dangling protocols. However, there is no evidence available in the literature that supports the use of a dangling protocol. Methods This is a multicenter randomized controlled trial that includes patients with a free flap lower leg reconstruction. The primary outcome is to assess whether a no-dangling protocol is not inferior to a dangling protocol, in terms of proportion of partial flap loss, 6 months after surgery. Secondary objectives are to identify differences in major and minor complications, length of stay, and costs, and to objectify blood gaseous changes during dangling. Furthermore, at 2 years we will assess difference in physical function, infection rates, and osseous union rates. Discussion The primary outcome of this study will give a more decisive answer to the question of whether a dangling protocol is necessary after a free flap reconstruction of the lower leg. The secondary outcomes of this study will provide a better insight into the physical functions, infection rates, and union rates in these patients.
KW - Free flap
KW - Lower leg
KW - Dangling
KW - Complications
KW - Physical function
KW - Infection
KW - Union
KW - Costs
KW - LOWER-EXTREMITY
U2 - 10.1186/s13063-019-3665-0
DO - 10.1186/s13063-019-3665-0
M3 - Article
VL - 20
JO - TRIALS
JF - TRIALS
SN - 1745-6215
IS - 1
M1 - 558
ER -