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Tests for the DNA of high-risk types of human papillomavirus (HPV) have a higher sensitivity for cervical intraepithelial neoplasia grade 3 or worse (CIN3+) than does cytological testing, but the necessity of such testing in cervical screening has been debated. Our aim was to determine whether the effectiveness of cervical screening improves when HPV DNA testing is implemented. Women aged 29–56 years who were participating in the regular cervical screening programme in the Netherlands were randomly assigned to combined cytological and HPV DNA testing or to conventional cytological testing only. After 5 years, combined cytological and HPV DNA testing were done in both groups. The primary outcome measure was the number of CIN3+ lesions detected. Analyses were done by intention to treat. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN20781131. 8575 women in the intervention group and 8580 in the control group were recruited, followed up for sufficient time (≥6·5 years), and met eligibility criteria for our analyses. More CIN3+ lesions were detected at baseline in the intervention group than in the control group (68/8575 vs 40/8580, 70% increase, 95% CI 15–151; p=0·007). The number of CIN3+ lesions detected in the subsequent round was lower in the intervention group than in the control group (24/8413 vs 54/8456, 55% decrease, 95% CI 28–72; p=0·001). The number of CIN3+ lesions over the two rounds did not differ between groups. The implementation of HPV DNA testing in cervical screening leads to earlier detection of CIN3+ lesions. Earlier detection of such lesions could permit an extension of the screening interval.

Human papillomavirus (HPV) testing of self-collected vaginal samples has potential to improve coverage of cervical screening programmes, but current guidelines mostly require those HPV positive on a self-sample to attend for routine screening. A pragmatic modified stepped-wedge implementation feasibility trial was conducted at primary care practices in England. Individuals aged 25 to 64 years who were at least 6 months overdue for cervical screening could provide a self-collected sample. The primary outcomes included the monthly proportion of non-attenders screened, changes in coverage, and uptake within 90 days. Self-samples from 7,739 individuals were analysed using Roche Cobas 4800. Individuals with a positive self-sample were encouraged to attend clinical screening. In this post hoc study of the trial, we related the HPV type (HPV16, HPV18, or other high-risk type) and cycle threshold (Ct) value on the self-sample to the results of clinician-collected sample and cervical intraepithelial neoplasia grade 2 or worse (CIN2+). We wished to triage HPV-positive individuals to immediate colposcopy, clinician sampling, or 12-month recall depending on risk. A total of 1,001 women tested positive through self-samples, and 855 women who had both an HPV-positive self-sample and a subsequent clinician-sample were included in this study. Of these, 71 (8.3%) had CIN2+. Self-sample Ct values were highly predictive of HPV in the clinician sample. Combining HPV type and Ct value allowed stratification into 3 risk groups; 44/855 (5%) were high-risk of whom 43% (19/44, 95% confidence interval [29.7%, 57.8%]) had CIN2+. The majority (52.9%, 452/855) were low-risk, of whom 4% (18/452, 95% CI [2.5%, 6.2%]) had CIN2+. The main limitation of our study was the colposcopy assessment was restricted to individuals who had abnormal cytology after positive results of both self-sample and clinician-collected sample. HPV type and Ct value on HPV-positive self-samples may be used for triage. The difference in the risk of CIN2+ in these groups appears sufficient to justify differential clinical management. A prospective study employing such triage to evaluate laboratory workflow, acceptability, and follow-up procedure and to optimise clinical performance seems warranted. ISRCTN12759467.

Introduction and hypothesis This prospective multi-centre true two-sided equivalence trial was designed to test the clinical equivalence of open (ASCP) and laparoscopic (LSCP) sacrocolpopexy using objective and subjective outcomes Methods The study was carried out in three urogynaecology units in England, UK and the patient population consisted of women referred with symptomatic and bothersome post-hysterectomy vaginal vault prolapse at least 1 cm above or beyond the hymeneal remnants. The interventions were either abdominal or laparoscopic sacrocolpopexy following randomisation to one of the types of surgery. Results For the primary outcome (point C on the POP-Q) the results at 1 year were −6.63 cm for the open ASCP and −6.67 cm for the LSCP respectively. Subjective outcomes at 1 year showed that 90% of the ASCP group and 80% of the LSCP group were “much better”. There were improvements with regard to blood loss, haemoglobin and shorter length of stay in the LSCP group compared with the ASCP group. Conclusion This fully powered randomised controlled trial comparing open and laparoscopic sacrocolpopexy has shown clinical equivalence.

Postmenopausal women are faced with difficulties in colposcopy, such as easy bleeding from epithelial atrophy, and thinning, atypical colposcopy images, unsatisfactory exposure, and decreased sensitivity of colposcopy. We aimed to improve the sensitivity and satisfaction of colposcopy in postmenopausal women and to evaluate the clinical efficacy of compound sea-buckthorn oil suppository on topical vaginal pretreatment in postmenopausal women prior to colposcopy. Postmenopausal patients who underwent colposcopy in the Obstetrics and Gynecology Hospital of Fudan University from April 2023 to July 2024 were randomly assigned to three groups: (A) untreated control group, (B) compound sea-buckthorn oil suppository group, (C) estrogen ointment group. Group B and group C were treated for 2 weeks before colposcopy, and the colposcopy and adverse reactions were analyzed. A total of 377 patients were included in this study, of which 9 patients were excluded from the colposcopy results for failing to complete the 2-week medication, and 368 patients were included in the colposcopy results, including 125 patients in group A, 121 patients in group B, and 122 patients in group C. The high-risk HPV infection before colposcopy accounted for 94.3% (347/368), of which HPV16 and/or HPV18 infection accounted for 20.4% (75/368), and other types of infection accounted for 75.3% (277/368). The patients with abnormal cytology (ASCUS and above) accounted for 47.6% (175/368). No significant differences were observed in age, cytology before colposcopy, and HPV type among the three groups. There were 196 cases (53.3%) of abnormal pathologies in postoperative colposcopic biopsy, among which 42 cases were high-grade cervical squamous intraepithelial lesions. After 2 weeks of medication, the integrity of vaginal epithelium, the adequacy ratio of colposcopy, and the satisfaction rate of acetic acid test and iodine staining test in groups B and C were significantly improved compared with group A ( P  < 0.001), and there was no significant difference between groups B and C. The incidence of breast discomfort in the estrogen ointment group was 5.6%, while the incidence of dizziness and headache was 4%. In contrast, no such side effects were reported in the compound sea-buckthorn oil suppository group, and the difference was statistically significant. Additionally, there was no significant statistical difference in local vaginal adverse reactions between groups B and C. Compound sea-buckthorn oil suppositories are helpful in improving the sensitivity and satisfaction of postmenopausal women with colposcopy, reduce blind biopsies. The effects are not inferior to estrogen. Compared to estrogen ointment, compound sea-buckthorn oil suppositories are most cost-effective and have fewer side effects and can be applied in clinical practice.

The complications inherent to conization include vaginal bleeding, cervical stenosis, amenorrhea, dysmenorrhea, and deep dyspareunia. Cervical stenosis is the most important complication due to the clinical repercussions. Studies show rates of cervical stenosis ranging from 1.3 to 19% after the Loop Electrosurgical Excision Procedure (LEEP). Our primary outcome was to compare the role of a new endocervical device to prevent cervical stenosis after LEEP in patients with high-grade squamous intraepithelial lesions (HSILs). A randomized clinical trial was performed including phases II and III for evaluation of a new device for cervical stenosis prevention. In Phase II, we included 25 patients who underwent LEEP and placement of the device to assess its toxicity and efficacy. In phase III, we compared two groups (with and without the use of an anti-stenosis device) to evaluate its efficacy and safety. From August 2015 to June 2018, 265 participants were randomized (Phase II: 25, Phase III: 120 with DUDA and 120 without DUDA). The toxicity during phase II was observed in only one patient (4%) with pain grade > 7. There were 7 cases of toxicity during Phase III, 2 in the DUDA group (1.8%), and 5 in the No DUDA group (4.5%). The complications rate was numerically higher in the No DUDA group (2.5x higher) than the DUDA group, but this difference did not reach statistical significance (p = 0.52). The rate of cervical stenosis in DUDA group was (4-7,3%), and in No DUDA group was (4.3-5.8%) (p = 0.5). We did not find a significant difference when comparing the evolution at 3, 6, and 12 months in terms of cervical patency and visualization of the squamocolumnar junction (SCJ) during colposcopy. The DUDA group exhibited 15% to 19% nonvisualization of the SCJ, whereas that rate ranged from 10 to 12% in the No DUDA group. The rate of cervical stenosis was not different comparing the use of a new device, specifically produced to prevent cervical stenosis, compared to no use after LEEP procedure. This clinical trial opens up space for a discussion of the utility of using cervical stenosis devices after LEEP. Perhaps in another type of conization it can be evaluated to avoid cervical stenosis.

IntroductionColposcopy is the most important diagnostic tool to detect cervical precancerous lesions and thereby prevention of cervical cancer. Due to age-dependent changes of the cervix, colposcopy is challenging in postmenopausal women, as the majority will have a non-visible transformation zone, resulting in increased risk of missing disease, a diagnostic cone biopsy and prolonged follow-up with repeated colposcopies. This study will be among the first to investigate, if treatment with vaginal oestrogen prior to colposcopy will improve the colposcopy performance, to ensure accurate and timely diagnosis of precancerous cervical lesions among postmenopausal women.Methods and analysisA randomised blinded controlled multicentre study. Enrolment will be performed at gynaecology departments in Central Denmark Region and Region of Southern Denmark. A total of 150 postmenopausal women aged ≥50 years referred for colposcopy due to abnormal cervical screening results will be randomised 1:1 to either pretreatment with vaginal application of Vagifem 30 µg or placebo once a day for 14 days prior to colposcopy. The primary outcome will be to compare the percentage of women in the two groups with a visible transformation zone at colposcopy, and biopsies representative of the transformation zone. Secondary outcomes will be the proportion of detected cervical intraepithelial neoplasia grade 2 or higher in the cervical biopsies; the proportion of diagnostics cone biopsies; the patients’ report on possible side effects and compliance to the pretreatment.Ethics and disseminationThe study has been approved by the Central Denmark Region Committee on Biomedical Research Ethics (1-10-72-34-22), the Central Denmark Regions’ Research Unit (1-16-02-72-22) and The Danish Health Authority (Danish Medicine Agency; 2022015030). The study’s EudraCT number is (1-23-456; 2022-000269-42) and it is registered on www.clinicaltrials.gov. The local Good Clinical Practice (GCP) unit will supervise and monitor the study closely before, during and after the study period. Findings will be disseminated in peer-reviewed scientific journals and presented in relevant conferences.Trial registration numberNCT05283421.

BackgroundCervical cancer remains a significant global health concern and is the fourth most prevalent cancer among women. In South Africa, it is the leading cause of cancer-related deaths in women aged 15–44 years. The disease is typically preceded by persistent high-risk HPV infection, leading to cervical intraepithelial neoplasia and eventually cancer. Currently, in South Africa, management primarily involves excision, particularly through large loop excision of the transformation zone, which has associated risks and limitations. Thermal ablation is an alternative cost-effective treatment method, providing a straightforward approach to treatment, particularly advantageous in environments characterised by limited resources. The study aims to assess the efficacy, safety and patient experience of thermal ablation, providing valuable data for potential integration into South Africa’s cervical cancer prevention policies.MethodsRandomised controlled trial in which 420 women living with HIV aged 30–60 years will be recruited from the Colposcopy Clinic at Tygerberg Hospital and will be followed up for a period of two years. The primary study endpoint is a test of cure that will be assessed by HPV genotyping, cervical cytology and histology at six month intervals. Other endpoints include the occurrence of adverse events.Ethics and disseminationThe study protocol has been approved by the Health Research Ethics Committee of Stellenbosch University (Ethics Reference No: M20/11/035) and by the Western Cape Department of Health and Wellness via the National Health Research Database (WC_202109_016). All study procedures comply with the Declaration of Helsinki, South African Good Clinical Practice Guidelines and the Medical Research Council’s ethical guidelines. Trial results will be disseminated through peer-reviewed journals, national and international conference presentations and professional associations. A lay summary will be shared with the Community Advisory Board to guide community-level dissemination.Trial registration numberPan African Clinical Trial Registry: PACTR202504820339039.

Introduction and hypothesisWe compared vaginal hysterectomy with bilateral sacrospinous fixation plus an anterior polyvinylidene fluoride mesh versus abdominal sacrocolpopexy for the treatment of primary apical prolapse in postmenopausal women.MethodsA prospective, randomized, single-blind, parallel study [Registro Brasileiro de Ensaios Clinicos (REBEC) trial register code RBR-7t6rg2] was performed from October 2015 to May 2016. A total of 71 postmenopausal women with advanced pelvic organ prolapse (POP) and undergoing surgery were randomized to the abdominal sacrocolpopexy (ASC) (n = 36) or the vaginal sacrospinous fixation with anterior mesh (VSF-AM) (n = 35) groups. Pelvic Organ Prolapse Quantification (POP-Q) system classification was performed for objective assessment, and the International Consultation on Incontinence Questionnaire–Vaginal Symptoms (ICIQ-VS), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) questionnaires were filled out for subjective evaluation by women before and 1 year after surgery. All procedures were performed by a single surgeon.ResultsBoth groups had improvement in almost POP-Q points (except for vaginal length in the VSF-AM group) and all ICIQ scores. The ASC group had a longer operative time (129 versus 117 min, p = 0.0038) and duration for return to activities (103 versus 57 days, p < .05). Four women (11%) in the VSF-AM group were reoperated versus none from the ASC group (p = .05).ConclusionsAlthough the study did not achieve the planned recruitment, after 12 months of follow-up, ASC did not differ from VSF-AM in objective and subjective scores (ICIQ questionnaires; POP-Q measurements). Recovery time was longer after open abdominal surgery.

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).

Objectives: The objective of this study was to evaluate the efficacy of lidocaine spray in reducing the pain during colposcopy-directed cervical biopsy (CDB). Methods: From December 2017 to February 2019, 312 women undergoing CDBs were enrolled. The participants were randomized to three groups: group 1 (lidocaine spray), in which lidocaine spray was applied thoroughly to the cervix; group 2 (placebo), in which normal saline was applied thoroughly to the cervix; and group 3 (control), in which no anesthetic agent was applied to the cervix. Each woman completed a 10 cm visual analog scale to classify the subjective pain experience at three time points: baseline, immediately after biopsy, and 10 min after the procedure. The primary outcome of this study was the biopsy pain score. Results: The 312 enrolled women were randomly assigned to the three groups, amounting to 104 women per group. The clinical and pathological characteristics of the participants in all groups were comparable. The baseline, the biopsy, and the post-procedure pain scores were comparable among the three groups. There was a significant increase in the pain score from baseline to biopsy and from baseline to post-procedure in each group. The pain-score changes from baseline to biopsy in the lidocaine spray group significantly decreased when compared with the normal saline group (<0.001), and tended to decrease, though not significantly (p = 0.06), when compared with the control group. No complication with the intervention was observed. Conclusions: The application of lidocaine spray to the cervix has the benefit of reducing the pain associated with CDBs by a small amount. However, the intervention is safe and may be considered in nulliparous and/or overly anxious women undergoing the procedure.