Loop electrosurgical excision procedure with or without intraoperative colposcopy: a randomized trial.

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.

A randomized comparison of video demonstration versus hands-on training of medical students for vacuum delivery using Objective Structured Assessment of Technical Skills (OSATS).

BACKGROUND: To compare medical students' skills for vaginal operative delivery by vacuum extraction (VE) after hands-on training versus video demonstration. METHODS: We randomized medical students to an expert demonstration (group 1) or a hands-on (group 2) training using a standardized VE algorithm on a pelvic training model. Students were tested with a 40-item Objective Structured Assessment of Technical Skills (OSATS) scoring system after training and 4 days later. OSATS scores were the primary outcome. Performance time, self-assessment, confidence, and global rating scale were secondary outcomes. We assessed the constructive validity of OSATS in this VE model comparing metric scores of experts and students. RESULTS: In all, 137 students were randomized. OSATS scores were higher in group 2 (n = 63) compared with group 1 (n = 74) (32.89 ±â€Š6.39 vs 27.51 ±â€Š10.27, respectively; P < 0.0001). Global rating scale (1.49 ±â€Š0.76 vs 2.33 ±â€Š0.94, respectively; P < 0.0001), confidence (2.22 ±â€Š0.75 vs 3.26 ±â€Š0.94, respectively; P = 0.04), self-assessment (2.03 ±â€Š0.62 vs 2.51 ±â€Š0.77, respectively; P < 0.0001), and performance time (38.81 ±â€Š11.58 seconds vs 47.23 ±â€Š17.35 seconds, respectively; P = 0.001) also favored group 2. After 4 days, this effect persisted with OSATS scores still being significantly higher in group 2 (30.00 ±â€Š6.50 vs 25.59 ±â€Š6.09, respectively; P = 0.001). The assessed OSATS scores showed constructive validity. In a multiple linear regression analysis, group assignment independently influenced OSATS scores, whereas sex, handedness, sports activities, and type of curriculum were not independently associated with OSATS scores. CONCLUSIONS: Hands-on training is superior to video demonstration for teaching VE on a pelvic model.