OBJECTIVE: To evaluate the effect of annular electrode lacrimal duct reconstruction in improving the safety and efficacy of nasolacrimal duct stent implantation for treatment of nasolacrimal duct obstruction. METHODS: This randomized clinical trial was performed to compare the efficacy, success rate of intubation, time used for stent implantation, intraoperative pain, and extubation-assciated complications between nasolacrimal stent implantation with and without annular electrode lacrimal duct reconstruction. RESULTS: A total of 119 eligible patients were enrolled in this trial. The total curative rate at 6 months of follow up after extubation was 70.9% (83/117) in these patients, and was significnatly higher in pateinets with lacrimal duct reconstruction than in those without [80.6% (54/67) vs 58.0% (29/50); χ(2)=7.093, P<0.05]. The total success rate of stent implantation was 98.3% (117/119) in all the patients initially enrolled, and two patients experienced failure of stent implantation and were excluded; the success rate was signfiicantly higher in patients initially enrolled in the lacrimal duct reconstruction group (χ(2)=6.282, P<0.05). The median time required for intubation was shorter in lacrimal duct reconstruction group (12 s vs 33 s; Z=-36.722, P<0.05). The intendity of intraoperative pain was comparable between the two groups (t=0.833, P=0.405). The total rate of puncta injury was 43.6% (51/117) in these patients and similar between the two groups (χ(2)=1.459, P=0.227). The total rate of extubation difficulty was 9.4% (11/117) in all the patients, and was lower in lacrimal duct reconstruction group [4.5% (3/67) vs 16% (8/50); χ(2)=4.463, P<0.05]. Stent breakage in extubation occurred in 4.3% (11/117) of the patients with similar rates between the two groups (χ(2)=2.964, P=0.085). Spearman bivariate correlation analysis showed that the time required for intubation was inversely correlated with the treatment efficacy (r=-0.584, P<0.05) and positively with the occurrence of extubation difficulty (r=0.491, P<0.05); extubation difficulty was inversely correlated with the curative effect (r=-0.511, P<0.05). CONCLUSION: Annular electrode nasolacrimal duct reconstruction can increase the safety and efficacy of nasolacrimal duct stent implantation for treatment of nasolacrimal duct obstruction.
RCT Entities:
OBJECTIVE: To evaluate the effect of annular electrode lacrimal duct reconstruction in improving the safety and efficacy of nasolacrimal duct stent implantation for treatment of nasolacrimal duct obstruction. METHODS: This randomized clinical trial was performed to compare the efficacy, success rate of intubation, time used for stent implantation, intraoperative pain, and extubation-assciated complications between nasolacrimal stent implantation with and without annular electrode lacrimal duct reconstruction. RESULTS: A total of 119 eligible patients were enrolled in this trial. The total curative rate at 6 months of follow up after extubation was 70.9% (83/117) in these patients, and was significnatly higher in pateinets with lacrimal duct reconstruction than in those without [80.6% (54/67) vs 58.0% (29/50); χ(2)=7.093, P<0.05]. The total success rate of stent implantation was 98.3% (117/119) in all the patients initially enrolled, and two patients experienced failure of stent implantation and were excluded; the success rate was signfiicantly higher in patients initially enrolled in the lacrimal duct reconstruction group (χ(2)=6.282, P<0.05). The median time required for intubation was shorter in lacrimal duct reconstruction group (12 s vs 33 s; Z=-36.722, P<0.05). The intendity of intraoperative pain was comparable between the two groups (t=0.833, P=0.405). The total rate of puncta injury was 43.6% (51/117) in these patients and similar between the two groups (χ(2)=1.459, P=0.227). The total rate of extubation difficulty was 9.4% (11/117) in all the patients, and was lower in lacrimal duct reconstruction group [4.5% (3/67) vs 16% (8/50); χ(2)=4.463, P<0.05]. Stent breakage in extubation occurred in 4.3% (11/117) of the patients with similar rates between the two groups (χ(2)=2.964, P=0.085). Spearman bivariate correlation analysis showed that the time required for intubation was inversely correlated with the treatment efficacy (r=-0.584, P<0.05) and positively with the occurrence of extubation difficulty (r=0.491, P<0.05); extubation difficulty was inversely correlated with the curative effect (r=-0.511, P<0.05). CONCLUSION: Annular electrode nasolacrimal duct reconstruction can increase the safety and efficacy of nasolacrimal duct stent implantation for treatment of nasolacrimal duct obstruction.