Video colposcopy versus headlight for large loop excision of the transformation zone (LLETZ): a randomised trial

Abstract

Purpose To compare resected cone mass and resection margin status when performing Large Loop Excision of the Transformation Zone (LLETZ) using video colposcopy (LLETZ-VC) versus a headlight (LLETZ-HL) in women with cervical dysplasia. Methods Prospective, randomised trial (monocentric) at a specialised cervical dysplasia unit in a University Hospital. Women with a biopsy-proven CIN2 + or persisting CIN1 or diagnostic LLETZ were recruited and randomised. LLETZ was performed either under video colposcopic vision or using a standard surgical headlight. The primary endpoint was resected cone mass. Secondary endpoints were the rate of involved margins, fragmentation of the specimen, procedure time, time to complete haemostasis (TCH), blood loss, pain, intra- and postoperative complications, and surgeon preference. Results LLETZ-VC and LLETZ-HL (109 women each) had comparable cone masses (1.57 [0.98–2.37] vs. 1.67 [1.15–2.46] grams; P = 0.454). TCH was significantly shorter in the LLETZ-VC arm (60 [41–95.2] vs. 90 [47.2–130.2] seconds; P = 0.008). There was no statistically significant difference in involved resection margins (6/87 [6.5%] vs. 16/101 [13.7%], P = 0.068) and postoperative complications (13/82 [13.7%] vs. 22/72 [23.4%], P = 0.085). Patient-reported outcomes favoured LLETZ-VC with a lower use of analgesics (6/80 [7.0%] vs. 17/87 [16.3%]; P = 0.049). However, LLETZ-VC was more difficult to perform with significantly lower ratings for handling (7 [5–9] vs. 9 [8–10]; P < 0.001) and general satisfaction (7.5 [5–9] vs. 10 [8–10]; P < 0.001). Conclusion Intraoperative video colposcopy for LLETZ has minimal benefits at the cost of surgeons’ satisfaction. Clinical trial registration NCT04326049 (ClinicalTrials.gov).

Innovative Diagnostic and Therapeutic Interventions in Cervical Dysplasia: A Systematic Review of Controlled Trials

“…Using the remaining 37 citations, cross reference searching identified two further appropriate citations. Thus, in summary, 39 citations reporting on diagnostic and therapeutic interventions in women with cervical dysplasia within a controlled trial setting were included in this review [ 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 ]. Among them, we found 5 PCTs [ 13 , 14 , 15 , 16 , 17 ] and 28 RCTs [ 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , …”

“…The clinical characteristics of individual studies reporting on therapeutic procedures in women with cervical dysplasia are shown in Table 2 . We identified 20 RCTs with 3355 participants [ 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 ] and one PCT with 297 participants [ 17 ]. in total, 4 RCTs found that alternative electrosurgical techniques such as Straight Wire Excision of the Transformation Zone (SWETZ), Contour-Loop Excision of the Transformation Zone (C-LETZ), and True Cone Biopsy Electrode Excision (TCBEE) were comparable to the standard LEEP/LLETZ procedure with minimal differences regarding specimen fragmentation and endocervical resection margin status [ 26 , 27 , 28 , 31 ].…”

“…in total, 4 RCTs found that alternative electrosurgical techniques such as Straight Wire Excision of the Transformation Zone (SWETZ), Contour-Loop Excision of the Transformation Zone (C-LETZ), and True Cone Biopsy Electrode Excision (TCBEE) were comparable to the standard LEEP/LLETZ procedure with minimal differences regarding specimen fragmentation and endocervical resection margin status [ 26 , 27 , 28 , 31 ]. LEEP performed under direct colposcopic vision led to smaller cone sizes without compromising margin status [ 33 ], but video colposcopy did not have this benefit [ 44 ]. Spray coagulation was better than forced coagulation for intra-operative bleeding control [ 29 ] and a chitosan tampon effectively reduced post-operative bleeding episodes [ 37 ].…”

“…Therefore, evidence-based diagnostic and therapeutic interventions for LSIL/HSIL are an important worldwide medical need. In order to clarify what progress has been made in this field during the last decade, we systematically searched the literature between 2012 and 2021 and identified 39 high-quality controlled trials, RCTs, and PCTs, reporting on diagnostic and therapeutic interventions in women with cervical dysplasia [ 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 ]. Among them, we found 5 PCTs [ 13 , 14 , 15 , 16 , 17 ] and 28 RCTs [ 18 , 19 , 20 , 21 , 22 , 23 , 24 , ...…”