Hilal Z, et al. - The relevance of performing Loop Electrosurgical Excision Procedure (LEEP) under colposcopic guidance in women with cervical dysplasia was determined. Researchers achieved significantly smaller cone specimens without compromising margin status using LEEP-direct colposcopic vision.

Methods

• Researchers performed a prospective, randomized trial comparing LEEP with LEEP performed under direct colposcopic vision (LEEP-DCV) in a 1:1 ratio.
• Resected cone mass was assessed as the primary endpoint.
• Margin status, fragmentation of the surgical specimen, procedure time, time to complete hemostasis (TCH), blood loss, and intra- and postoperative complications were the secondary endpoints of this work.
• With an assumed type I error of 0.05 and drop-out rate of 5%, they planned a sample size of 87 per group (n=174) to achieve 90% power to detect a 25% reduction in cone mass (with an assumed cone mass of 2.5±1.6g in the control group) using a non-parametric test (Mann-Whitney U).

Results

• Randomization of 182 women was performed between October 2016 and December 2017; 93 in the LEEP group and 89 in the LEEP-DCV group.
• Significantly smaller cone specimens were obtained from women undergoing LEEP-DCV than those undergoing LEEP (weight: median 1.86 [interquartile range 1.20–2.72] vs 2.37 [1.63–3.31] grams, respectively; P=.006).
• The groups demonstrated no significant differences in terms of secondary outcome measures: resection margin status R1 vs R0: 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 (138–294) and 171 (133–290) seconds; TCH: 61 (31–108) and 51 (30–81) seconds; intraoperative blood loss (ΔHb): 0.4 (0.2–1.0) and 0.5 (0.1–0.9); complication rate: 6 (6.5%) and 2 (2.2%).
• As per multivariate analysis, the amount of resected cone mass was independently related to study group allocation (P=.021) and parity (P=.028), but not to age, body mass index, type of transformation zone, and dysplasia degree.