American journal of obstetrics and gynecology · 2018
Loop electrosurgical excision procedure with or without intraoperative colposcopy: a randomized trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Hilal Ziad, Rezniczek Günther A, Alici Ferizan, Kumpernatz Anne, Dogan Askin, Alieva Lale, Tempfer Clemens B
Аннотация
BACKGROUND: Loop electrosurgical excision procedure is the standard surgical treatment for cervical dysplasia. Loop electrosurgical excision procedure is advised to be performed under colposcopic guidance to minimize adverse pregnancy outcomes. To date, there is no evidence from randomized trials for this recommendation.
OBJECTIVE: We sought to assess the benefits of performing loop electrosurgical excision procedure under colposcopic guidance in women with cervical dysplasia.
STUDY DESIGN: In a prospective, randomized trial, we compared loop electrosurgical excision procedure with loop electrosurgical excision procedure performed under direct colposcopic vision in a 1:1 ratio. The primary endpoint was resected cone mass; the secondary endpoints were margin status, fragmentation of the surgical specimen, procedure time, time to complete hemostasis, blood loss, and intraoperative and postoperative complications. A sample size of 87 per group (n = 174) was planned (with an assumed type I error of 0.05 and drop-out rate of 5%) to achieve 90% power to detect a 25% reduction in cone mass (with an assumed cone mass of 2.5 ± 1.6 g in the control group) using a nonparametric test (Mann-Whitney U).
RESULTS: From October 2016 through December 2017, we randomized 182 women: 93 in the loop electrosurgical excision procedure group and 89 in the loop electrosurgical excision procedure-direct colposcopic vision group. Women undergoing loop electrosurgical excision procedure-direct colposcopic vision had significantly smaller cone specimens than those undergoing loop electrosurgical excision procedure (weight: median 1.86 [interquartile range 1.20-2.72] vs median 2.37 [interquartile range 1.63-3.31] g, respectively, P = .006). Secondary outcome measures did not differ significantly between groups: resection margin status involved vs free margin: 12 (13%) vs 75 (82%) and 11 (12.4%) vs 75 (84.3%); fragmentation no vs yes: 85 (92.4%) vs 7 (7.6%) and 84 (94.4%) vs 5 (5.6%); procedure time: 190 (interquartile range 138-294) and 171 (interquartile range 133-290) seconds; time to complete hemostasis: 61 (interquartile range 31-108) and 51 (interquartile range 30-81) seconds; intraoperative blood loss (Δhemoglobin): 0.4 (interquartile range 0.2-1.0) and 0.5 (interquartile range 0.1-0.9); complication rate: 6 (6.5%) and 2 (2.2%). In a multivariate analysis, study group allocation (P = .021) and parity (P = .028), but not age, body mass index, type of transformation zone, and dysplasia degree independently influenced the amount of resected cone mass.
CONCLUSION: Loop electrosurgical excision procedure with intraoperative colposcopy leads to significantly smaller cone specimens without compromising margin status.
OBJECTIVE: We sought to assess the benefits of performing loop electrosurgical excision procedure under colposcopic guidance in women with cervical dysplasia.
STUDY DESIGN: In a prospective, randomized trial, we compared loop electrosurgical excision procedure with loop electrosurgical excision procedure performed under direct colposcopic vision in a 1:1 ratio. The primary endpoint was resected cone mass; the secondary endpoints were margin status, fragmentation of the surgical specimen, procedure time, time to complete hemostasis, blood loss, and intraoperative and postoperative complications. A sample size of 87 per group (n = 174) was planned (with an assumed type I error of 0.05 and drop-out rate of 5%) to achieve 90% power to detect a 25% reduction in cone mass (with an assumed cone mass of 2.5 ± 1.6 g in the control group) using a nonparametric test (Mann-Whitney U).
RESULTS: From October 2016 through December 2017, we randomized 182 women: 93 in the loop electrosurgical excision procedure group and 89 in the loop electrosurgical excision procedure-direct colposcopic vision group. Women undergoing loop electrosurgical excision procedure-direct colposcopic vision had significantly smaller cone specimens than those undergoing loop electrosurgical excision procedure (weight: median 1.86 [interquartile range 1.20-2.72] vs median 2.37 [interquartile range 1.63-3.31] g, respectively, P = .006). Secondary outcome measures did not differ significantly between groups: resection margin status involved vs free margin: 12 (13%) vs 75 (82%) and 11 (12.4%) vs 75 (84.3%); fragmentation no vs yes: 85 (92.4%) vs 7 (7.6%) and 84 (94.4%) vs 5 (5.6%); procedure time: 190 (interquartile range 138-294) and 171 (interquartile range 133-290) seconds; time to complete hemostasis: 61 (interquartile range 31-108) and 51 (interquartile range 30-81) seconds; intraoperative blood loss (Δhemoglobin): 0.4 (interquartile range 0.2-1.0) and 0.5 (interquartile range 0.1-0.9); complication rate: 6 (6.5%) and 2 (2.2%). In a multivariate analysis, study group allocation (P = .021) and parity (P = .028), but not age, body mass index, type of transformation zone, and dysplasia degree independently influenced the amount of resected cone mass.
CONCLUSION: Loop electrosurgical excision procedure with intraoperative colposcopy leads to significantly smaller cone specimens without compromising margin status.