Obstetrics & Gynecology · Medical Literature
Early colposcopy in non-16/18 high-risk human papillomavirus positivity with normal cytology.
Abstract
Very few clinical studies have been done to evaluate the potential clinical benefit of utilizing early colposcopy in women with normal Pap smear cytology but positive for high-risk human papillomavirus types other than human papillomavirus 16 or human papillomavirus 18 in a screening population for cervical cancer. The aim of this study was to compare two follow-up strategies and assess the need for colposcopy at the initial visit, based on cytology, human papillomavirus testing, and colposcopic findings at 1 year, among study participants. In total, 122 women who had negative Pap smears and were positive for high-risk types of human papillomavirus (not human papillomavirus 16/18) were randomly allocated to two groups via simple computer-generated randomization. Notably, one group had a colposcopic examination when they were first diagnosed (61), and the other group had standard Pap/human papillomavirus follow-up without a colposcopic examination (61). All women in both groups had repeat Pap and human papillomavirus testing and a colposcopic examination after 1 year. Rates of loop electrosurgical excision procedure application were similar between groups (11.5 and 8.2%; p=0.343). So early colposcopy has enabled the treatment of high-grade squamous intraepithelial lesion lesions without increasing the number of loop electrosurgical excision procedures. In women who had negative cytology yet positive high-risk human papillomavirus types other than human papillomavirus 16/18, there was no statistically significant difference in either high-risk human papillomavirus persistence, abnormal cytology rates, or loop electrosurgical excision procedure requirements at a 1-year follow-up after having their colposcopy performed early vs. delayed assessments. This suggests that these patients can be appropriately managed with risk-based follow-up care.
Clinical relevance
In women with normal Pap smear cytology who test positive for non-HPV-16/18 high-risk HPV types, does immediate colposcopy at the time of initial diagnosis improve clinical outcomes compared to standard 1-year co-testing surveillance? __SNAPSHOT__ {"studyDesign":"Randomized controlled trial (simple computer-generated randomization, two parallel arms)","setting":"Not reported (authorship suggests a Turkish tertiary gynecology center based on author affiliations and journal context; not explicitly stated in abstract)","sampleSize":"n=122 (early colposcopy arm: n=61; surveillance arm: n=61)","population":"Women with negative Pap smear (NILM cytology) who tested positive for non-HPV-16/18 high-risk HPV types on cervical cancer screening; additional inclusion/exclusion criteria not reported in abstract","intervention":"Immediate colposcopic examination at the time of initial diagnosis (early colposcopy group), followed by repeat Pap and HPV co-testing plus colposcopy at 1 year","comparator":"Standard surveillance: repeat Pap smear and HPV co-testing without initial colposcopy, followed by colposcopic examination at 1 year","primaryOutcome":"Not explicitly defined as a single pre-specified primary endpoint in the abstract; outcomes assessed include loop electrosurgical excision procedure (LEEP) application rates, cytology results, HPV test results, and colposcopic findings at 1-year follow-up","followUp":"1 year","fundingSource":"Not reported"}
Key findings
The sole quantitative outcome reported in the available abstract is the rate of loop electrosurgical excision procedure (LEEP) application, which was 11.5% in the early colposcopy group versus 8.2% in the standard surveillance group (p=0.343). This difference was not statistically significant. The abstract is truncated and does not report colposcopic findings, CIN grades, HPV clearance rates, cytological progression rates, confidence intervals, absolute risk differences, relative risks, or NNT/NNH. No adverse event data, patient-reported outcomes, or subgroup analyses are reported in the available text. NNT and NNH cannot be calculated from the data provided. No other effect sizes or p-values are available for analysis.
Practice implications
This small RCT addresses a clinically meaningful and actively debated question: whether immediate colposcopy offers benefit over guideline-recommended 1-year surveillance in women with NILM cytology and non-16/18 hrHPV positivity. Current ASCCP 2019 guidelines recommend 1-year co-test surveillance for this intermediate-risk group rather than immediate colposcopy. The only outcome reported — LEEP application rate — did not differ significantly between arms (11.5% vs. 8.2%; p=0.343), providing no evidence that early colposcopy increased the detection of lesions requiring treatment. However, because the abstract is truncated, the full spectrum of findings — including histological detection rates of CIN2+, HPV persistence, colposcopic abnormality rates, and 1-year outcome details — cannot be evaluated. The study appears underpowered to detect modest but clinically meaningful differences in LEEP rates or CIN2+ detection. Findings are potentially applicable to adult women undergoing routine cervical cancer screening with non-16/18 hrHPV positivity and normal cytology, but generalizability is limited by the small sample size, unclear setting, and incomplete data availability. This summary is based solely on an abstract; full-text review is essential before drawing practice conclusions. IMPORTANT LIMITATION NOTE: Only the abstract was available for this analysis; conclusions must be considered preliminary pending full-text review. __LIMITATIONS__ Very small sample size (n=122 total; 61 per arm) with high likelihood of being underpowered to detect clinically meaningful differences in LEEP rates or lesion detection,Abstract is truncated — key outcomes including CIN2+ histological detection rates, HPV clearance or persistence rates, colposcopic abnormality grades, and 1-year composite outcomes are not reported,No pre-specified primary endpoint is clearly identified in the abstract, raising concerns about outcome selection and multiplicity,No blinding described — colposcopy outcomes are inherently subject to detection bias, and clinicians performing 1-year colposcopy were likely aware of prior management assignment,Short follow-up of only 1 year; insufficient to assess long-term cancer risk or HPV clearance trajectories,Setting not explicitly reported; limits assessment of generalizability to other healthcare systems or HPV prevalence populations,Funding source not reported; potential for undisclosed conflicts of interest cannot be excluded,The p-value for the LEEP rate difference (p=0.343) is consistent with a null result, but the study lacks power to distinguish a true null effect from a type II error,Specific non-16/18 hrHPV genotypes (e.g., 31, 33, 45, 52, 58) not disaggregated, though genotype-specific risk varies substantially and would affect clinical relevance,Women who may have been lost to follow-up or excluded are not described __BOTTOM_LINE_CATEGORY__ promising_but_preliminary __BOTTOM_LINE__ This small RCT found no statistically significant difference in LEEP application rates between immediate colposcopy and standard 1-year co-test surveillance in women with NILM cytology and non-16/18 hrHPV positivity (11.5% vs. 8.2%; p=0.343), providing limited preliminary support for current guideline-recommended surveillance over immediate colposcopy. However, the study is substantially underpowered, the abstract is truncated, and key histological outcomes are not reported, making it insufficient to confirm or change practice. Clinicians should continue following ASCCP 2019 risk-based guidelines until adequately powered trials with full outcome reporting are available.