Loop Electrosurgical Excision Procedure Treatment Research Articles

Comparative Study of 5-Aminolevulinic Acid-Mediated Photodynamic Therapy and the Loop Electrosurgical Excision Procedure for the Treatment of Cervical High-Grade Squamous Intraepithelial Lesions.

The loop electrosurgical excision procedure (LEEP) is a common treatment for cervical intraepithelial neoplasia (CIN). Photodynamic therapy (PDT) mediated by 5-aminolevulinic acid (ALA) is a non-invasive modality that has been used for treating precancerous diseases and HPV infections. This comparative study evaluated the efficacy and safety of ALA PDT and the LEEP in the treatment of cervical high-grade squamous intraepithelial lesions (HSILs). Patient records were reviewed and HSIL patients with HPV infections (24-51 years old) who underwent PDT or LEEP treatment were selected. Efficacy was analyzed blindly based on HPV-DNA, cytology, and colposcopy-directed biopsy obtained at 6 months after treatment. Treatment-related discomfort and side effects were also analyzed. Cure rates of 88.1% and 70.0% were achieved for the PDT group and LEEP group (p < 0.05), respectively. HPV-negative conversion rates of 81.0% and 62.0% were achieved for the PDT group and LEEP group (p < 0.05), respectively. The overall lesion remission rate of the PDT group was 19% higher than that of the LEEP group. The incidence of side effects was much lower in the PDT group. These results show that ALA PDT is a feasible non-invasive treatment for cervical HSIL.

Unraveling cervical cancer screening dilemmas: histopathological insights from VIA and LEEP at bugando medical centre, Mwanza

BackgroundThe single-visit strategy, also known as the “screen-and-treat” approach, is widely used to screen for cervical cancer in low- and middle-income countries. The screen-and-treat approach leads to unnecessary or inadequate treatment. Thus, a study was conducted to determine the histopathological patterns of aceto-white lesions on visual inspection with acetic acid (VIA) in patients who underwent a Loop Electrosurgical Excision Procedure (LEEP) at Bugando Medical Centre between January 2016 and December 2020.MethodA 5-year retrospective cross-sectional case record review was conducted on 329 women who had LEEP at Bugando Medical Centre following a positive VIA cervical screening test. A standard data abstraction form was used to collect patient information. Missing client information records and LEEP without histopathological results were exclusion criteria. For statistical analysis, STATA version 15 was used; in descriptive statistics, frequency, mean, and standard deviation were used. The Chi2 and Fisher’s exact tests were used to investigate the relationship between patient characteristics and histopathological patterns, and a P-value of 0.05 was considered statistically significant in multinomial models.ResultsThis study looked at 329 patients who had LEEP following a VIA positive but were not eligible for cryotherapy. Our study participants had a mean age of 40 ± 8.2 SD. There were 203 (61.7%) patients with benign lesions, including 4 with schistosomiasis and 2 with cervical tuberculosis. The precancerous lesions were discovered in 100 cases (30.4%), and 26 (7.9%) already had invasive cervical cancer. Out of 100 patients with precancerous lesions, 58 (17.6%) and 42 (12.8%) have high- and low-grade squamous intraepithelial (HSIL and LSIL) lesions, respectively. The presence of a precancerous lesion was found to be associated with age 31–40 years (P-value 0.042) and HIV positivity (P-value 0.004).ConclusionMost patients in this study had benign cervical lesions, which do not require LEEP treatment. Nonetheless, a considerable percentage of invasive cervical malignancies and rare benign diseases such as schistosomiasis and cervical tuberculosis were identified. A screen-and-treat approach within well-equipped tertiary hospitals like Bugando Medical Centre should explore alternative options instead of relying solely on straight LEEP.

(109) Analysis of Patient-Specific Microbiome Profiles and Possible Association with Sexual Dysfunction After Cervical Dysplasia Treatment

Abstract Introduction Electrocautery of the cervix during the loop electrosurgical excision procedure (LEEP) effectively treats cervical dysplasia (CD). Most patients do not report adverse symptoms post-operatively. However, a subset of patients has reported sexual issues and psychosexual sequalae, including some impact to their quality of life. The etiology of these symptoms has not been investigated, especially in a functional capacity. Moreover, there is some evidence that LEEP alters the cervical microbiome, from a small number of studies. Given the close anatomical relatedness of the pelvis, regions in close proximity to the cervix should also be considered, such as the vagina and urethra. Together, these three regions comprise the female urogenital tract (FUT), which should be examined for persistent inflammatory bacterial profiles post-LEEP. Correlations between LEEP patient-reported symptoms of psychological and sexual issues, and bacterial microbiome profiles, have not yet been investigated. Objective To analyze overall and individualized bacterial profiles (cervix, vagina, urethra) of patients with CD before and after treatment with LEEP and investigate associations with sexual functioning. Methods Women with typical female internal organs and external genitalia, undergoing LEEP treatment for CD, were recruited to participate in the study. Urethral samples, in addition to vaginal and cervical swabs, were collected immediately before treatment and 3 months post-treatment. Bacterial community analysis was characterized by 16S ribosomal RNA gene analysis. Self-report online surveys assessing demographics, medical history, and sexual function (FSFI) were completed by participants at the same time intervals. Chi square analyses and t-tests were conducted. Results Alpha diversity (observed species richness) revealed a significant decrease in species richness in the FUT microbiome post-LEEP (P &amp;lt; 0.05). Beta diversity demonstrated significant differences between the cervical, urinary, and vaginal microbiomes pre- and post-LEEP (P &amp;lt; 0.05). Lactobacillus was observed to be significantly higher in the cervical microbiome (P &amp;lt; 0.05), and Prevotella, Dialister, and Ruminococcus were significantly lower in the cervical microbiome (P &amp;lt; 0.05), when compared to the urinary and vaginal microbiomes pre- and post-LEEP. Analysis of individual microbiome patient profiles revealed individuals who showed discordant trends when compared to data summarizing averages. Namely, a subset of participants experienced a significant increase (P &amp;lt; 0.05) in pro-inflammatory bacteria post-LEEP with correlative changes in SD. These results suggest there may be a non-uniform healing response post-LEEP, and that individualized microbiome analysis could reveal regional dysbiosis that could be subsequently treated and managed. Conclusions A diverse inflammatory bacterial community characterizes CD in the FUT, and treatment with LEEP mostly returns the microbiomes to a healthy state. However, some participants showed increased inflammatory bacterial profiles post-LEEP, potentially demonstrating a non-uniform healing response. This study provides a basis for future studies to screen and restore FUT microbiomes post-LEEP, with the aim of detecting and treating any bothersome symptoms reported by patients. Disclosure No

Comparing loop electrosurgical procedure pathology results in the inpatient and outpatient setting (474)

<b>Objectives:</b> In the management of cervical intraepithelial neoplasia (CIN), loop electrosurgical excision procedure (LEEP) provides diagnostic information and may be therapeutic. Margin status is a key prognostic factor, given that patients with positive margins demonstrate a five-fold increased risk of any grade CIN recurrence. LEEP can be safely performed in inpatient or outpatient settings as dictated by patient preference, equipment availability, and anatomic considerations. However, there is limited evidence comparing outcomes as they relate to the LEEP treatment settings. We sought to evaluate quality outcomes and margin status of inpatient versus outpatient LEEPs. <b>Methods:</b> All patients who underwent LEEP between April 2019 and August 2021 at a single institution were identified. Chart review was conducted to extract patient demographics, clinical risk factors, and pathology outcomes. Mann-Whitney U and Chi-square tests were used for statistical analysis. <b>Results:</b> We analyzed 291 LEEP specimens, 254 (87%) in the outpatient setting and 37 (13%) in the inpatient setting. Table 1 lists patient characteristics and pathologic outcomes data. There was a significant difference in the median age, BMI, and parity between the two groups. The reasons for inpatient LEEP listed were difficult anatomy (<i>n</i>=12, 32%), lack of access to equipment required for LEEP (<i>n</i>=11, 30%), patient preference (<i>n</i>=4, 11%), concern for malignancy (<i>n</i>=3, 8%), patient comorbidity (<i>n</i>=3, 8%), large area of dysplasia (<i>n</i>=2, 5%), and combined case with other inpatient procedure (<i>n</i>=2, 5%). All comorbid conditions were related to bleeding disorders. There were significant differences between colposcopy and LEEP pathology results with respect to grade of dysplasia and evidence of malignancy. No significant differences were identified with respect to the frequency of thermal artifact affecting pathologic interpretation of margin status. Interestingly, LEEPs performed in the inpatient setting were associated with greater specimen depth and multiple tissue samples (not including endocervical curettage) compared to outpatient LEEPs. <b>Conclusions:</b> In this single-institution, retrospective study, there was no significant difference between inpatient and outpatient LEEP procedures with respect to the thermal artifact and margin status. This may result from the more ubiquitous use of P16 immunohistochemical staining to evaluate specimen margins. Although the depth of the resected specimen was significantly greater when performed in the operating room, there was also an apparent increase in specimen number, potentially reflecting larger visible lesions requiring multiple resections. These results suggest that outpatient LEEP procedures may be equally effective in managing CIN, with potential cost implications.

Diagnosis of Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma by Cervical Biopsy under Colposcopy and Analysis of Factors Influencing.

Objective To explore the diagnosis of cervical intraepithelial neoplasia (CIN) and invasive cervical carcinoma (ICC) by cervical biopsy under colposcopy and analyze the factors influencing the detection. Methods The clinical data of 134 CIN confirmed by colposcopy biopsy in our hospital from June 2018 to October 2019 and subsequent LEEP treatment were analyzed retrospectively. All patients were diagnosed pathologically after the operation. The diagnosis of CIN by cervical biopsy under colposcopy was observed. The influencing factors of CIN and ICC detected by colposcopy biopsy were analyzed by the pathological results of loop electrosurgical excision procedure (LEEP) as the gold standard. Results After LEEP, the number of the no intraepithelial or malignant lesions (NILM) or ICC were higher than that of colposcopy biopsy, and CIN-III was lower than that of colposcopy biopsy, the differences were all statistically significant (P < 0.05). Among the 134 patients, the coincidence rate between colposcopy biopsy and LEEP examination results was 79.10% (106/134), and postoperative pathological findings showed that there were 13 cases (9.70%) with the pathological upgrade and 19 cases (14.18%) with pathological decrease. Multivariate logistic analysis showed that the image quality of colposcopy image, atypical blood vessels, biopsy sampling method, and visible lesion area of the cervix were the independent influencing factors for the detection of CIN and ICC by colposcopy biopsy (P < 0.05). Conclusion CIN and ICC can be diagnosed by colposcopy cervical biopsy and postoperative histopathology. However, there are still some missed and misdiagnosed cervical biopsies under colposcopy, and the combined detection of the two can further ensure the diagnosis rate. The clinical registration number is E2018091.

Adjuvant VACcination against HPV in surgical treatment of Cervical Intra-epithelial Neoplasia (VACCIN study) a study protocol for a randomised controlled trial

BackgroundCervical cancer is caused by Human Papilloma viruses (HPV) and is preceded by precursor stages: Cervical Intraepithelial Neoplasia (CIN). CIN is mostly found in women in their reproductive age and treated with a Loop Electrosurgical Excision Procedure (LEEP). The recurrence or residual disease rate after treatment is up to 17%. These women have a lifelong increased risk of recurrent CIN, cervical cancer and other HPV related malignancies. Furthermore, LEEP treatments are associated with complications such as premature birth. Limited data show that prophylactic HPV vaccination at the time of LEEP reduces recurrence rates, therefore leading to a reduction in repeated surgical interventions and side effect like preterm birth.The primary study objective is to evaluate the efficacy of the nonavalent HPV vaccination in women with a CIN II-III (high-grade squamous intraepithelial lesion (HSIL) lesion who will undergo a LEEP in preventing recurrent CIN II-III after 24 months.MethodsThis study is a randomised, double blinded, placebo controlled trial in 750 patients without prior HPV vaccination or prior treatment for CIN and with histologically proven CIN II-III (independent of their hrHPV status) for whom a LEEP is planned. Included patients will be randomised to receive either three injections with nonavalent (9 HPV types) HPV vaccine or placebo injections (NaCL 0.9%) as a comparator. Treatment and follow-up will be according the current Dutch guidelines. Primary outcome is recurrence of a CIN II or CIN III lesion at 24 months. A normal PAP smear with negative hrHPV test serves as surrogate for absence of CIN. At the start and throughout the study HPV typing, quality of life and cost effectiveness will be tested.DiscussionAlthough prophylactic HPV vaccines are highly effective, little is known about the effectivity of HPV vaccines on women with CIN. Multiple LEEP treatments are associated with complications. We would like to evaluate the efficacy of HPV vaccination in addition to LEEP treatment to prevent residual or recurrent cervical dysplasia and decrease risks of repeated surgical treatment.Trial registrationMedical Ethical Committee approval number: NL66775.078.18. Affiliation: Erasmus Medical Centre. Dutch trial register: NL 7938. Date of registration 2019-08-05.

Expression of p16 and HPV E4 on biopsy samples and methylation of FAM19A4 and miR124-2 on cervical cytology samples in the classification of cervical squamous intraepithelial lesions.

The decision to treat a cervical squamous intraepithelial lesion (SIL) by loop electrosurgical excision procedure (LEEP) relies heavily on a colposcopy‐directed biopsy showing high‐grade (H)SIL. Diagnosis is often supported by p16, an immunohistochemical (IHC) biomarker of high‐risk (hr)HPV E7 gene activity. Additional potential markers include methylation of tumor suppressor genes FAM19A4/miR124‐2 in cervical cytology for advanced transforming HSIL and the IHC marker HPV E4 for productive, potentially regressing lesions. In 318 women referred for colposcopy, we investigated the relationship between staining patterns of p16 and E4 IHC in the worst biopsy, and the relation of these to FAM19A4/miR124‐2 methylation status in cytology. E4‐positive staining decreased with increasing SIL/CIN grade from 41% in LSIL to 3% in HSIL/CIN3. E4 positivity increased with grade of p16 when p16 expression was limited to the lower two third of the epithelium (r = 0.378), but fell with expression over. Loss of E4 expression in the worst lesion was associated with the methylation of FAM19A4/miR124‐2. We also examined whether these biomarkers can predict the histological outcome of the LEEP biopsy in a subgroup of 119 who underwent LEEP treatment. About 85% of women with ≥lower two third p16 staining/E4‐negative HSIL biopsies and 65% with limited p16 staining/E4‐positive HSIL biopsies had ≥HSIL in the LEEP specimen (P = .025). p16 expression in a biopsy is related both to viral production and transformation, while decreased E4 expression relates to methylation, indicating advanced HSIL. p16 expression in ≥2/3 of the epithelium and absent E4 indicate likely HSIL on a subsequent LEEP specimen.

Menstrual Blood Human Papillomavirus DNA and TAP1 Gene Polymorphisms as Potential Biomarkers for Screening and Monitoring of Cervical Squamous Intraepithelial Lesion.

Human papillomavirus (HPV) is a known causative factor in the etiology of cervical cancer. HPV DNA genotyping was performed in menstrual blood (MB) collected in napkins from patients with cervical intraepithelial neoplasia (CIN), HPV infection and sexually active apparently normal subjects. In the same patient cohort, MB TAP1 I333V and TAP1 D637G gene polymorphisms were examined. The sensitivity, specificity, and positive and negative predictive values of HPV DNA in the detection of CIN or HPV infection were 83% (223 of 268), 98% (131 of 134), 99% (223 of 226), and 74% (131 of 176), respectively. Moreover, HPV DNA was found in 24% (28/118) patients who had loop electrosurgical excision procedure treatment and 0% (0/76) HPV infected or CIN1 patient with proven recovery. On the other hand, the risk of developing high-grade CIN was significantly reduced for AG and GG genotypes compared with AA genotype and for carriers with a G allele compared with those with an A allele for both polymorphisms. MB HPV DNA is a potential noninvasive marker for screening and monitoring of squamous intraepithelial lesion. Together with TAP1 I333V and TAP1 D637G gene polymorphisms, the combined test may be useful for stratifying high-risk patients for better follow-up strategies.

Cervical microbiome is altered in cervical intraepithelial neoplasia after loop electrosurgical excision procedure in china

Although human papillomavirus (HPV) infection is a major cause leading to the development of cervical intraepithelial neoplasia (CIN), the relationship between genital microbiome and HPV persistence/clearance is not well established. Loop electrosurgical excision procedure (LEEP) is one of standard treatments of CIN 2/3 globally, yet little is known about how the LEEP influence genital microbiota. We conducted a prospective study of 26 patients with CIN2/3 who underwent analysis of cervical microbiome before and after 3 months of LEEP treatment. Cervical swabs were collected, and microbiomes were analyzed by 16S ribosomal RNA gene sequencing. A decrease of cervical microbial diversity was observed after 3 months of LEEP treatment. Notably, a significant shift from community type of a Prevotella-containing and lack of a consistent dominant species to lactobacillus iners dominated microbiome correlated with LEEP. Particularly, Leptotrichia and clostridium were further decreased after LEEP treatment (P = 0.049 and P = 0.002, respectively). Our results suggest that the cervical microbiome is altered after LEEP treatment in patients with CIN2/3. Further studies with larger sample sizes are needed to validate these findings.

A randomized clinical trial comparing cervical dysplasia treatment with cryotherapy vs loop electrosurgical excision procedure in HIV-seropositive women from Johannesburg, South Africa

Mortality associated with cervical cancer is a public health concern for women, particularly in HIV-seropositive women in resource-limited countries. HIV-seropositive women are at a higher risk of high-grade cervical precancer, which can eventually progress to invasive carcinoma as compared to HIV-seronegative women. It is imperative to identify effective treatment methods for high-grade cervical precursors among HIV-seropositive women. Randomized controlled trial data are needed comparing cryotherapy vs loop electrosurgical excision procedure treatment efficacy in HIV-seropositive women. Our primary aim was to compare the difference in the efficacy of loop electrosurgical excision procedure vs cryotherapy for the treatment of high-grade cervical intraepithelial neoplasia (grade ≥2) among HIV-seropositive women by conducting a randomized clinical trial. HIV-seropositive women (n= 166) aged 18-65 years with histology-proven cervical intraepithelial neoplasia grade ≥2 were randomized (1:1) to cryotherapy or loop electrosurgical excision procedure treatment at a government hospital in Johannesburg. Treatment efficacy was compared using 6- and 12-month cumulative incidence posttreatment of: (1) cervical intraepithelial neoplasia grade ≥2; (2) secondary endpoints of histologic cervical intraepithelial neoplasia grade ≥3 and grade ≥1; and (3) high-grade and low-grade cervical cytology. The study was registered (ClinicalTrials.govNCT01723956). From January 2010 through August 2014, 166 participants were randomized (86 loop electrosurgical excision procedure; 80 cryotherapy). Cumulative cervical intraepithelial neoplasia grade ≥2 incidence was higher for cryotherapy (24.3%; 95% confidence interval, 16.1-35.8) than loop electrosurgical excision procedure at 6 months (10.8%; 95% confidence interval, 5.7-19.8) (P= .02), although by 12 months, the difference was not significant (27.2%; 95% confidence interval, 18.5-38.9 vs 18.5%; 95% confidence interval, 11.6-28.8, P= .21). Cumulative cervical intraepithelial neoplasia grade ≥1 incidence for cryotherapy (89.2%; 95% confidence interval, 80.9-94.9) did not differ from loop electrosurgical excision procedure (78.3%; 95% confidence interval, 68.9-86.4) at 6 months (P= .06); cumulative cervical intraepithelial neoplasia grade ≥1 incidence by 12 months was higher for cryotherapy (98.5%; 95% confidence interval, 92.7-99.8) than loop electrosurgical excision procedure (89.8%; 95% confidence interval, 82.1-95.2) (P= .02). Cumulative high-grade cytology incidence was higher for cryotherapy (41.9%) than loop electrosurgical excision procedure at 6 months (18.1%, P < .01) and 12 months (44.8% vs 19.4%, P < .001). Cumulative incidence of low-grade cytology or greater in cryotherapy (90.5%) did not differ from loop electrosurgical excision procedure at 6 months (80.7%, P= .08); by 12 months, cumulative incidence of low-grade cytology or greater was higher in cryotherapy (100%) than loop electrosurgical excision procedure (94.8%, P= .03). No serious adverse effects were recorded. Although rates of cumulative cervical intraepithelial neoplasia grade ≥2 were lower after loop electrosurgical excision procedure than cryotherapy treatment at 6 months, both treatments appeared effective in reducing cervical intraepithelial neoplasia grade ≥2 by >70% by 12 months. The difference in cumulative cervical intraepithelial neoplasia grade ≥2 incidence between the 2 treatment methods by 12 months was not statistically significant. Relatively high cervical intraepithelial neoplasia grade ≥2 recurrence rates, indicating treatment failure, were observed in both treatment arms by 12 months. A different treatment protocol should be considered to optimally treat cervical intraepithelial neoplasia grade ≥2 in HIV-seropositive women.

Cervical cancer screening uptake and challenges in Malawi from 2011 to 2015: retrospective cohort study.

BackgroundMalawi has the highest cervical cancer incidence and mortality in the world with age-standardized rate (ASR) of 75.9 and 49.8 per 100,000 population respectively. In response, Ministry of Health established a cervical cancer screening programme using visual inspection with acetic acid (VIA) and treatment of precancerous lesions with cryotherapy. This paper highlights the roll out, integration with family planning services and HIV ART Programme, uptake and challenges of VIA and Cryotherapy programme.MethodsWe analyzed program data, supportive supervision, quarterly and annual reports from the National Cervical Cancer Control Program. We evaluated the uptake and challenges of screening services by age, HIV serostatus and trends over a five year period (2011–2015).ResultsBetween 2011 and 2015, number of cervical cancer screening sites, number of women screened and coverage per annum increased from 75 to 130, 15,331 to 49,301 and 9.3 % to 26.5 % respectively. In this five year period, a total of 145,015 women were screened. Of these, 7,349 (5.1 %) and 6,289 (4.3 %) were VIA positive and suspect cancer respectively. Overall 13,638 (9.4 %) were detected to be VIA positive or had suspect cancer. Of the 48,588 women with known age screened in 2015; 13,642 (28.1 %), 27,275 (56.1 %) and 7,671 (15.8 %) were aged 29 or less, 30–45, 46 years or more. Among 39,101 women with data on HIV serostatus; 21,546 (55.1 %) were HIV negative, 6,209 (15.9 %) were HIV positive and 11, 346 (29.0 %) status was unknown. VIA positivity rate and prevalence of suspect cancer were significantly higher in HIV positive than HIV negative women (8.8 % vs 5.0 %, 6.4 % vs 3.0 %); in women aged 30–45 years than women aged 29 years or less (5.6 % vs 2.3 %, 2.6 % vs 1.2 %) respectively, all p <0.05). The main challenge of the programme was failure to treat VIA positive women eligible for cryotherapy. Over the five year period, the programme only treated 1,001 (43.3 %) out of 2,311 eligible women and only 266 (31.8 %) of the 836 women with large lesion or suspect cancer who were referred, received the health care at the referral centre. The reasons for failure to provide cryotherapy treatment were stock out of gas, faulty/broken cryotherapy machine (usually connectors or probes) or no cryotherapy machine at all in the whole district. For women with large lesion or suspect cancer; lack of loop electrosurgical excision procedure (LEEP) machine or inadequate gynaecologists at the referral centre, were the major reasons. Cancer radiotherapy services were not available in Malawi.ConclusionsThis study provided data on VIA positivity rate, prevalence of suspect cancer, failure rate of cryotherapy and challenges in the provision of cryotherapy and LEEP treatment in Malawi. These data could be used as baseline for monitoring and evaluation of Human Papillomavirus (HPV) vaccination programme which the country introduced in 2013, the linkage of cervical cancer screening and women on HIV ART and the long term effect of ART, voluntary male medical circumcision on the prevalence and incidence of cervical cancer.

Overtreatment and Cost-Effectiveness of the See-and-Treat Strategy for Managing Cervical Precancer.

See-and-treat using loop electrosurgical excision procedure (LEEP) has been recommended as an alternative in managing high-grade cervical squamous intraepithelial lesions, but existing literature lacks evidence of the strategy's cost-effectiveness. We evaluated the overtreatment and cost-effectiveness of the see-and-treat strategy compared with usual care. We modeled a hypothetical cohort of 40-year-old females who had not been screened for cervical cancer and followed them through their lifetimes using a Markov model. From a U.S. health-system perspective, the analysis was conducted in 2012 dollars and measured effectiveness in quality-adjusted life-years (QALY). We estimated incremental cost-effectiveness ratios (ICER) using a willingness-to-pay threshold of $50,000/QALY. The robustness of the see-and-treat strategy's cost-effectiveness and its overtreatment rates were further examined in various sensitivity analyses. In the base-case, the see-and-treat strategy yielded an ICER of $70,774/QALY compared with usual care. For most scenarios in the deterministic sensitivity analysis, this strategy had ICERs larger than $50,000/QALY, and its cost-effectiveness was sensitive to the disutility of LEEP treatment and biopsy-directed treatment adherence under usual care. Probabilistic sensitivity analysis showed that the see-and-treat strategy had a 50.1% chance to be cost-effective. It had an average overtreatment rate of 7.1% and a 78.8% chance to have its overtreatment rate lower than the 10% threshold. The see-and-treat strategy induced an acceptable overtreatment rate. Its cost-effectiveness, compared with usual care, was indiscriminating at the chosen willingness-to-pay threshold but much improved when the threshold increased. The see-and-treat strategy was reasonable for particular settings, that is, those with low treatment adherence. Cancer Epidemiol Biomarkers Prev; 25(5); 807-14. ©2016 AACR.

S17.1 Cervical cancer prevention in hiv-infected women

HIV-infected women are living longer and are at a higher risk of acquiring cervical cancer. More data comparing cervical cancer screening and treatment strategies in these women are urgently needed. WHO guidelines on optimal methods to screen and treat cervical cancer are available, but there are limited data to inform their potential modification for HIV-infected women. Even fewer data are available which compare the efficacy of treatment methods (loop electrosurgical excision procedure (LEEP) and cryotherapy) and differences in cervical disease recurrence between HIV-infected and HIV-uninfected women. HPV testing appears to be the most sensitive, although less specific for CIN-2+ detection than either VIA and cytology screening. Several studies of HIV-infected women have shown equivalent sensitivity of VIA and of cytology screening for CIN-2+, although there is variation in results. Consistently across studies, the specificity of cytology appears higher than either VIA or for high-risk HPV testing. Two studies in South Africa and Kenya have suggested that the specificity of HPV testing and VIA for detection of high grade lesions is lower in HIV-infected women with lower CD4 counts; more research is needed to examine if screening test performance varies for HIV-infected women with higher versus lower CD4 counts. More research in HIV-infected women is needed to examine if LEEP and cryotherapy treatment methods are associated with differences in HIV-viral shedding and in HIV transmission during or shortly after treatment. HIV-infected adolescents have found to induce high-levels of neutralizing antibody titers following prophylactic HPV vaccination in bridging studies. Studies are not yet available on HPV vaccine efficacy in HIV infected women against either HPV-infection or clinical disease endpoints.

The relationship between previous treatment for cervical dysplasia and preterm delivery in twin gestations

Objective: To describe the impact of previous cervical surgery on preterm birth prior to 34 weeks in twins.Methods: A retrospective review of twin pregnancies delivered between January 1998 and December 2005 at two institutions was performed. Women with a prior cold knife cone (CKC), loop electrosurgical excision procedure (LEEP), or ablative procedure were compared to a control group of women who had not undergone a previous treatment for cervical dysplasia. The primary outcome was delivery before 34 weeks of gestation.Results: A total of 876 women met inclusion criteria. Of these, 110 (12.6%) had previous surgical procedures for cervical dysplasia, including CKC (n = 10), LEEP (n = 36), cryotherapy (n = 59) and CO2 laser treatment (n = 5). Delivery prior to 34 weeks was more common in women with a previous CKC compared to women with no prior treatment (40% versus 11.3%; odds ratio [OR], 3.6; 95% confidence interval [CI], 1.7–8.0). Delivery prior to 34 weeks was not more common in women with a previous LEEP (8.3%; OR, 0.8; 95% CI, 0.3–2.3) or ablative procedure (9.4%; OR, 0.9; 95% CI, 0.4–1.9) in comparison to the untreated group. Adjusting for the potential confounders of age, tobacco use, infertility treatments and previous preterm birth did not change the results.Conclusions: Previous CKC is associated with delivery prior to 34 weeks while LEEP and ablative procedures are not. CKC should be carefully considered and avoided when possible in reproductive age women.

Clinical observation of cervical intra-epithelial neoplasia with high risk HPV infection after LEEP treatment

Objective To explore the curative effect of loop electrosurgical excision procedure (LEEP) on cervical intra-epithelial neoplasia(CIN) infected with high risk human papilloma virus (HR-HPV).Methods 80 CIN patients with HPV infection underwent LEEP were selected.HR-HPV DNA load was detected before operation and 3 months after operation,and at the same time,vaginal examination and cervical directed biopsy were conducted.Results Before LEEP operation,the differences between different levels of CIN HPV load were not significant(P ＞0.05,F =0.45).3 months after operation,CIN Ⅰ grade 19 cases (86.4％) turned to chronic inflammation,CIN Ⅱgrade 36 cases (83.7％) turned to chronic inflammation,CINⅢ grade 13 patients (86.6％) were chronic inflammation.Cervical HPV load postoperatively negative rate was 85％ and the lower HPV load,the higher postoperatively negative rate.Conclusion LEEP is the effective treatment for cervical lesion and can significantly decrease the HPV-DNA loading at cervix. Key words: LEEP; CIN ; Papillomavirus, human

Same day colposcopic examination and loop electrosurgical excision procedure (LEEP) presents minimal overtreatment and averts delay in treatment of cervical intraepithelial neoplasia in Kenyatta National Hospital, Kenya

Background: Screening for cancer of the cervix at Kenyatta National Hospital (KNH), follows the recommended three-step strategy; Papanicolaou (Pap) smear, colposcopy/biopsy and loop electrosurgical excision procedure (LEEP)/biopsy. This approach poses the following challenges: multiple clinic visits, costly, time consuming, long turnaround time to treatment, non-compliance and loss-to-follow-up. Objective: To determine the agreement between histologies following colposcopy and LEEP amongst women in KNH as a forerunner for opportunity to shift from the three-step approach to the two-step “see and treat” (same-day colposcopy and LEEP) approach. Methods: This was a retrospective descriptive cohort of Women who underwent LEEP procedure between January 2008 and 31st December 2010 following the three-step approach at KNH, Kenya. Results: A total of 124 patients out of the 132 patients who underwent LEEP were included in the analysis. The 8 patients excluded had missing files. HIV infected, uninfected or unknown women are similar socio-demographically. The mean (SD) age for the HIV infected, uninfected and unknown is 37 (6), 33 (10) and 35 (9) years respectively. Colposcopic and LEEP biopsy histology within patients demonstrated a high weighted kappa statistics agreement of 84%. LEEP increased diagnosis of invasive cancer. Patients had a median (IQR) 5 (4 - 6) clinic visits from Pap smear to LEEP treatment. It took median (IQR) 55 (27 - 116) days between Pap smear to colposcopy result and 167 (101 - 276) days between Pap smear results to LEEP treatment. If a LEEP procedure were to be performed in this cohort of women on the same day of the colposcopy biopsy a median (IQR) 77 (55 - 137) days could have been saved. Conclusion: There is a high agreement between colposcopy and LEEP biopsies in our setting offering a window of opportunity to perform “See and Treat” same-day colposcopy and LEEP treatment procedure, skipping the colposcopy biopsy stage.

Effect of loop electrosurgical excision procedure on outcome of subsequent fertility and pregnancy

Objective To investigate the effects of cervical loop electrosurgical excision procedure (LEEP) to fertility and pregnancy outcome of patients with cervical intraepithelial neoplasia (CIN).Methods 20 inpatients of CIN from January 2009 to August 2011 were given the LEEP treatment,as the observation group,while other 20 healthy pregnant women randomly selected within the same period of the pregnancy out-patient hospital treatment without history of gynecological surgery,were observed as the control group,the observed pregnancy rate and pregnancy outcome were examined.Results The pregnancy rate of the observation group of 20 patients was 85％ (17/20),preguancy rate was 90％ (18/20) in the control group,there was no significant difference (P＞ 0.05).Cesarean section rate of the observation group was significantly higher than that in the control group (P＜0.05),and there was also no significant difference in abortion incidence,incidence of preterm premature,rupture of membranes incidence and the incidence of small for gestational age (SGA) children in two groups(P＞0.05),no neonatal deaths occurred in the patients of two groups.Conclusion LEEP has no significant effect on the fertility of the CIN patients,without increasing the abortion rate,the rate of preterm birth,premature rupture of membranes,and incidence of SGA children. Key words: Loop electrosurgical excision procedure (LEEP); Cervical intraepithelial neoplasia; Fertility; Pregnancy outcome

Residual and recurrent disease rates following LEEP treatment in high-grade cervical intraepithelial lesions

Loop electrosurgical excision procedure (LEEP) is a basic procedure in the conization performed on patients with CIN II/III. After excisional therapy, close follow up is essential for the earlier detection of residual and recurrent disease. The value of PAP-smear and HPV-DNA tests for investigation of residual and recurrent disease in patients diagnosed with high-grade intraepithelial lesion after LEEP treatment was purposed. 42 patients were included in the study for whom epithelial cell anomalies were detected at PAP-smear screening. HPV-DNA test, colposcopy, cervical biopsy and endocervical curettage and then LEEP procedures were performed. The patients were followed with HPV DNA and PAP-smear tests in terms of recurrence and residual disease at 3-month intervals. HPV-DNA examination revealed that 36 patients (85.7%) were positive for high-risk HPV-DNA before treatment. Histopathological evaluation of LEEP materials revealed the presence of CIN I in 4 and CIN II/III in 38 patients. Surgical margin was positive in five patients. No sign of invasive cervical neoplasia was detected. The high-risk HPV DNA's persistence was observed in 11 (30.6%) of the 36 patients of whom HPV-DNA positivity had been detected before the treatment. HSIL was detected in four patients using PAP-smear on the third month examination. Positive LEEP surgical margins were found to be positively correlated both with HPV-DNA positivity detected during the follow-up examination and with the presence of residual disease in the follow-up PAP smear. LEEP is a basic procedure in the conization performed on patients with CIN II/III. In spite of high recurrence and residual disease rates, this kind of patients requires close monitoring. Follow-up with HPV and PAP-smear tests after LEEP treatment is of great importance in the detection of residual or recurrent disease.

Evaluation of a single-step diagnosis and treatment of premalignant cervical lesion by LEEP

Objective To explore whether a single-step diagnosis and treatment of premalignant cervical lesions by the loop electrosurgical excision procedure (LEEP) is appropriate in women at high risk in low-resource countries. Method Sixty women suspected of having a high-grade lesion on both visual inspection with acetic acid (VIA) and colposcopic examination were randomly allotted to one of 2 groups. In group 1, LEEP was performed immediately and a tissue specimen was sent for histopathologic evaluation; in group 2, a punch biopsy was performed, followed by a histopathologic evaluation; then, LEEP was performed if needed. Results Among the patients who underwent LEEP, 4 (16%) in group 1 and 3 (15.8%) in group 2 were overtreated. No patients dropped out of the study in group 1 but 5 (20.8%) did in group 2. Conclusion The single-step diagnosis and LEEP treatment of premalignant cervical lesions is appropriate in low-resource countries.

Loop electrosurgical excision of the cervix and subsequent risk for spontaneous preterm delivery: a population-based study of singleton deliveries during a 9-year period

Our aim was to assess the association between loop electrosurgical excision procedure (LEEP) and the subsequent risk for spontaneous preterm delivery, with the use of population-based data from various nationwide registries. The study population consisted of all singleton deliveries in Denmark during a 9-year period, 1997-2005. Information on the deliveries that included different cervical procedures was obtained from various national registries. In all, 552,678 deliveries were eligible for analyses. Of the deliveries in which the mother had no previous LEEP, 18,519 deliveries (3.5%) were preterm; when this data were applied to 530 preterm deliveries (6.9%) that were subsequent to LEEP, the yield was a significantly increased risk of preterm delivery, with an odds ratio of 2.07 (95% CI, 1.88-2.27; LEEP vs no LEEP). Our study showed an overall 2-fold increase in the risk of spontaneous preterm delivery in singleton deliveries subsequent to LEEP treatment, even after adjustment for various potential risk factors.