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DOI: 10.1055/s-0038-1671100
Large loop excision of the transformation zone with or without intraoperative colposcopy: A randomized trial
Publication History
Publication Date:
20 September 2018 (online)
Objective:
To assess the benefits of performing large loop excision of the transformation zone (LLETZ) under colposcopic guidance.
Methods:
In a prospective, randomized trial, we compared LLETZ with LLETZ performed under direct colposcopic vision (LLETZ-DCV). The primary endpoint was resected cone mass, the secondary endpoints were margin status, fragmentation of the surgical specimen, procedure time, time to complete hemostasis (TCH), blood loss, and intra- and postoperative complications. A sample size of 87 per group (n = 174) was planned (with an assumed drop-out rate of 5%) to achieve 90% power to detect a difference of 0.75 g with a SD of 1.6 in the primary outcome.
Results:
Between October 2016 and December 2017, we randomized 182 women, 93 in the LLETZ group and 89 in the LLETZ-DCV group. Women undergoing LLETZ-DCV had significantly smaller cone specimens than those undergoing LLETZ (weight: 1.86 [1.20 – 2.72] vs. 2.37 [1.63 – 3.31] grams, respectively; P= 0.006). Secondary outcome measures did not differ between groups: resection margin status R1 vs. R0: 12 (13%) vs. 75 (82%) and 11 (12.4%) vs. 75 (84.3%); P= 0.98; fragmentation no vs. yes: 85 (92.4%) vs. 7 (7.6%) and 84 (94.4%) vs. 5 (5.6%); P= 0.81; procedure time: 190 (138 – 294) and 171 (133 – 290) seconds; P= 0.64; TCH: 61 (31 – 108) and 51 (30 – 81) seconds; P= 0.23; intraoperative blood loss (ΔHb): 0.4 (0.2 – 1.0) and 0.5 (0.1 – 0.9); P= 0.99; complication rate: 6 (6.5%) and 2 (2.2%); P= 0.30.
Conclusion:
LLETZ-DCV leads to significantly smaller cone specimens without compromising margin status and should be the standard of care for patients undergoing cervical dysplasia surgery.