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.

Mozart for Reducing Patient Anxiety During Colposcopy: A Randomized Controlled Trial.

OBJECTIVE: To test whether music by Mozart reduces anxiety among patients undergoing colposcopy. METHODS: In a randomized multicenter trial, we measured the reduction of the situation-specific anxiety of women hearing Mozart's Symphony No. 40 during colposcopy compared with women not hearing music using the State-Trait Anxiety Inventory. Secondary endpoints were reduction of heart rate (beats per minute), pain during and 10 minutes after colposcopy, general unpleasantness, anxiety during colposcopy, and overall satisfaction (11-item visual analog scales). Analysis was by intention to treat. A sample size of 104 per group (N=208) was calculated to achieve 80% power to detect a difference of 4.8 with a SD of 12.3 in anxiety scores. RESULTS: Between February 2017 and May 2018, 212 women were randomized. The mean anxiety reduction was -9.4±10.8 SD in 103 women in the music group and -9.0±10.6 in 102 women in the control group (P=.40). The secondary endpoints reduction of heart rate (-16.3±16.9 vs -15.4±17.1; P=.37), pain during procedure (median 2 [interquartile range 1-4] vs 2 [1-3.5]; P=.80), pain 10 minutes after examination (1 [0-1.75] vs 1 [0-2]; P=.42), general unpleasantness (3 [1-5.75] vs 4 [1-5.5]; P=.35), anxiety during examination (2 [1-5] vs 2 [1-6]; P=.28), and overall satisfaction (10 [9-10] vs 10 [9-10]; P=.81) were also not different between the two study groups. CONCLUSION: Mozart's Symphony No. 40 does not reduce anxiety in women undergoing colposcopy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03005795.

Video Colposcopy for Reducing Patient Anxiety During Colposcopy: A Randomized Controlled Trial.

OBJECTIVE: To test whether video colposcopy reduces anxiety among patients undergoing colposcopy. METHODS: In a prospective, randomized multicenter trial, we compared video colposcopy and no video colposcopy in a one-to-one ratio. Situation-specific anxiety was measured before (S1) and after (S2) colposcopy using the State-Trait Anxiety Inventory. The primary endpoint was the reduction of the situation-specific anxiety scores (ΔS=S2-S1). Secondary endpoints were pain during and 10 minutes after colposcopy, general unpleasantness, anxiety during colposcopy, satisfaction with the information about the procedure, and overall satisfaction (11-item visual analog scales). Analysis was by intention to treat. A sample size of 104 per group (n=208) was planned to achieve 80% power to detect a difference of 4.8 with a SD of 12.3 in the primary outcome. RESULTS: Between August 2016 and March 2017, 225 women were randomized. The mean ΔS was -10.3±11.3 SD in 111 women in the video colposcopy group and -10.3±11.0 SD in 105 women without video colposcopy (P=.50). The secondary endpoints pain during examination (median 2 [interquartile range 1-3] compared with 2 [1-4]; P=.91), pain 10 minutes after examination (1 [0-3] compared with 1 [0-2.5]; P=.24), general unpleasantness (3 [1-5] compared with 3 [1-5]; P=.90), anxiety during examination (3 [1-5] compared with 3 [1-5]; P=.61), satisfaction with the information about the procedure (10 [9-10] compared with 10 [9-10]; P=.88), and overall satisfaction (10 [9-10] compared with 10 [9-10]; P=.54) were also not different between the two study groups. In a multivariate linear regression analysis, study center (P=.028), body mass index (P=.033), and smoking status (P=.025) independently affected the reduction of anxiety. CONCLUSION: Video colposcopy does not reduce anxiety in women undergoing colposcopy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02697175.

Objective Structured Assessment of Technical Skills (OSATS) evaluation of hysteroscopy training: a prospective study.

OBJECTIVES: To describe the performance curve of hysteroscopy-naïve probands repeatedly working through a surgery algorithm on a hysteroscopy trainer. STUDY DESIGN: We prospectively recruited medical students to a 30min demonstration session teaching a standardized surgery algorithm. Subjects subsequently performed three training courses immediately after training (T1) and after 24h (T2) and 48h (T3). Skills were recorded with a 20-item Objective Structured Assessment of Technical Skills (OSATS) at T1, T2, and T3. The presence of a sustained OSATS score improvement from T1 to T3 was the primary outcome. Performance time (PT) and self assessment (SA) were secondary outcomes. Statistics were performed using paired T-test and multiple linear regression analysis. RESULTS: 92 subjects were included. OSATS scores significantly improved over time from T1 to T2 (15.21±1.95 vs. 16.02±2.06, respectively; p<0.0001) and from T2 to T3 (16.02±2.06 vs. 16.95±1.61, respectively; p<0.0001). The secondary outcomes PT (414±119s vs. 357±88s vs. 304±91s; p<0.0001) and SA (3.02±0.85 vs. 3.80±0.76 vs. 4.41±0.67; p<0.0001) also showed an improvement over time with quicker performance and higher confidence. SA, but not PT demonstrated construct validity. In a multiple linear regression analysis, gender (odds ratio (OR) 0.96; 95% confidence interval (CI) 0.35-2.71; p=0.9) did not independently influence the likelihood of OSATS score improvement. CONCLUSIONS: In a hysteroscopy-naïve population, there is a continuous and sustained improvement of surgical proficiency and confidence after multiple training courses on a hysteroscopy trainer. Serial hysteroscopy trainings may be helpful for teaching hysteroscopy skills.