Abstract
PurposeTo 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.MethodsProspective, 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.ResultsLLETZ-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).ConclusionIntraoperative video colposcopy for LLETZ has minimal benefits at the cost of surgeons’ satisfaction.Clinical trial registrationNCT04326049 (ClinicalTrials.gov).
Highlights
Cervical Intraepithelial Neoplasia (CIN) is a major health concern affecting women worldwide
High-grade cervical dysplasia such as CIN2 + may progress to cervical cancer in 40–85% of cases depending on Human Papilloma Virus (HPV) subtype infection, host immunocompetence, and associated factors of progression such as smoking and concomitant infections [2]
In a PubMed literature search, for example, we identified no randomised trial on video colposcopy (search date 04-04-2021; search terms: (“Large Loop Excision of the Transformation Zone (LLETZ)”[All Fields] OR “LEEP”[All Fields]) AND (“intraop”[All Fields] OR “intraoperative”[All Fields] OR “intraoperatively”[All Fields]) AND (“colposcopy”[MeSH Terms] OR “colposcopy”[All Fields] OR “colposcopies”[All Fields]))
Summary
Cervical Intraepithelial Neoplasia (CIN) is a major health concern affecting women worldwide. Large Loop Excision of the Transformation Zone (LLETZ) which has replaced traditional cold-knife conization of the cervix [3]. In a meta-analysis of 26 randomized trials, the incidence of persistent or recurrent CIN after LLETZ was comparable with that after cold-knife conization, but LLETZ was faster, caused less intraoperative bleeding, and resulted in a shorter hospital stay. LLETZ may be performed under colposcopic guidance using a video colposcope to guarantee a sharp and magnified image. This may have advantages regarding the visibility of the cervix, the cervical canal, and cervical lesions as well as the identification of appropriate
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