Assessment of women's sexual quality of life after benign adnexal surgery using vNOTES approach in comparison to conventional laparoscopy: protocol for a randomised controlled trial.

INTRODUCTION: Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) has already proven its non-inferiority to conventional abdominal laparoscopy (CAL) for hysterectomy without conversion. The results in terms of efficacy and safety are promising. However, we note a lack of medical literature and no specific randomised controlled trial assessing women's sexual function after vNOTES for benign adnexal surgery. The aim of this RCT is to confirm the non-inferiority of the vNOTES approach for benign adnexal pathology compared with CAL on women's sexual function. Secondary outcomes will evaluate vNOTES's efficiency, morbidity and postoperative complications compared with CAL for benign adnexal surgery. The relationship between adnexal mass morcellation and the quality of the histological analysis will also be evaluated as secondary outcome. METHODS AND ANALYSIS: Women aged 18-70 years undergoing a benign adnexal surgery at the Geneva University Hospitals will be eligible and randomised with a 1:1 ratio to the CAL arm or the vNOTES arm, if inclusion criteria are met. Participants will complete the Female Sexual Function Index, the Couple Satisfaction Index-16 and a self-reported questionnaire on dyspareunia within 4 weeks prior to randomisation and at 3+6 months after surgery. General and clinical data will be collected when the patient is enrolled in the study, during hospitalisation and at 1 month postoperative to assess secondary outcomes.An absence of impairment on sexual function will be confirmed with a stability or an improvement of the evaluated scores in each group at 3 and 6 months postoperative compared with the preoperative scores. We expect to have no statistically significant difference in sexuality questionnaires scores between the two groups. ETHICS AND DISSEMINATION: Protocol of this study was validated by the Cantonal Research Ethics Commission of Geneva, Switzerland, on 9 August 2022. We aim to publish the study's results in peer-reviewed journals within 3 years. TRIAL REGISTRATION NUMBER: NCT05761275.

Telecytologic diagnosis of cervical smears for triage of self-sampled human papillomavirus-positive women in a resource-limited setting: concept development before implementation.

INTRODUCTION: Cytology is an option for triaging human papillomavirus (HPV)-positive women. The interpretation of cytologic slides requires expertise and financial resources that are not always available in resource-limited settings. A solution could be offered by manual preparation and digitization of slides on site for real-time remote cytologic diagnosis by specialists. In the present study, we evaluated the operational feasibility and cost of manual preparation and digitization of thin-layer slides and the diagnostic accuracy of screening with virtual microscopy. MATERIALS AND METHODS: Operational feasibility was evaluated on 30 cervical samples obtained during colposcopy. The simplicity of the process and cellularity and quality of digitized thin-layer slides were evaluated. The diagnostic accuracy of digital versus glass slides to detect cervical intraepithelial neoplasia grade 2 or worse was assessed using a cohort of 264 HPV-positive Cameroonian women aged 30 to 49 years. The histologic results served as the reference standard. RESULTS: Manual preparation was found to be feasible and economically viable. The quality characteristics of the digital slides were satisfactory, and the mean cellularity was 6078 squamous cells per slide. When using the atypical squamous cells of undetermined significance or worse threshold for positivity, the diagnostic performance of screening digital slides was not significantly different statistically compared with the same set of slides screened using a light microscope (P = 0.26). CONCLUSIONS: We have developed an innovative triage concept for HPV-positive women. A quality-ensured telecytologic diagnosis could be an effective solution in areas with a shortage of specialists, applying a same day "test-triage-treat" approach. Our results warrant further on-site clinical validation in a large prospective screening trial.

Transformation Zone Assessment Using Visual Inspection With Acetic Acid Before and After Thermal Ablation: Implications for Follow-Up.

PURPOSE: Thermal ablation (TA) has become the conventional method for treatment of precancerous cervical lesions in low-resource settings. After TA, both the squamocolumnar junction (SCJ) and the transformation zone (TZ) may be subject to change. Our aim was to evaluate SCJ and TZ variability after TA. METHODS: Study data were collected in a large prospective trial of a cervical cancer screening campaign in Cameroon. For each patient, two sets of cervical photos (native and with acetic acid) were taken before and 6-12 months after TA. The SCJ and TZ were evaluated independently by three observers according to the WHO nomenclature. When discordances were observed between the type of TZ and SCJ selected by each observer, a corrected TZ was established on the basis of the SCJ categorization. Interobserver agreement for TZ interpretation was evaluated using Cohen's kappa coefficient for agreement between two observers and Fleiss' kappa between three observers. RESULTS: Fifty consecutive participants were included in the analysis. Seventy-six percent were interpreted as TZ1-2, and 24% as TZ3 before TA. In 56% of cases, the entire SCJ could not be entirely visualized after TA, thus being recategorized as TZ3. Interobserver agreement was fair for diagnosis before TA (Kappa coefficient, 0.34; 95% CI, 0.27 to 0.45) and moderate for diagnosis after TA (Kappa coefficient, 0.40; 95% CI, 0.30 to 0.50). After TA, 36% progressed from TZ1-2 to TZ3, with a moderate interobserver agreement (Kappa coefficient, 0.44; 95% CI, 0.40 to 0.54). CONCLUSION: We observed a shift of the SCJ into the endocervical canal after TA. A significant proportion of participants had TZ 3 after treatment, raising the question of visual inspection with acetic acid's applicability as a first-line follow-up examination method after TA.

Inter- and intra-observer agreement in the assessment of the cervical transformation zone (TZ) by visual inspection with acetic acid (VIA) and its implications for a screen and treat approach: a reliability study.

BACKGROUND: In low-resource countries, interpretation of the transformation zone (TZ) using the classification of the International Federation for Cervical Pathology and Colposcopy (IFCPC), adopted by the World Health Organization, is critical for determining if visual inspection with acetic acid (VIA) screening and thermal ablation treatment are possible. We aim to assess inter- and intra-observer agreement in TZ interpretation. METHODS: We performed a prospective multi-observer reliability study. One hundred cervical digital images of Human papillomavirus positive women (30-49 years) were consecutively selected from a Cameroonian cervical cancer screening trial. Images of the native cervix and after VIA were obtained. The images were evaluated for the TZ type at two time points (rounds one and two) by five VIA experts from four countries (Côte d'Ivoire, Cameroon, Peru, and Zambia) according to the IFCPC classification (TZ1 = ectocervical fully visible; TZ2 = endocervical fully visible; TZ3 = not fully visible). Intra- and inter-observer agreement were measured by Fleiss' kappa. RESULTS: Overall, 37.0% of images were interpreted as TZ1, 36.4% as TZ2, and 26.6% as TZ3. Global inter-observer reliability indicated fair agreement in both rounds (kappa 0.313 and 0.288). The inter-observer agreement was moderate for TZ1 interpretation (0.460), slight for TZ2 (0.153), and fair for TZ3 (0.329). Intra-observer analysis showed fair agreement for two observers (0.356 and 0.345), moderate agreement for two other (0.562 and 0.549), and one with substantial agreement (0.728). CONCLUSION: Interpretation of the TZ using the IFCPC classification, adopted by the World Health Organization, is critical for determining if VIA screening and thermal ablation treatment are possible. However, the low inter- and intra-observer agreement suggest that the reliability of the referred classification is limited in the context of VIA. It's integration in treatment recommendations should be used with caution since TZ3 interpretation could lead to an important referral rate for further evaluation. Trial registration Cantonal Ethics Board of Geneva, Switzerland: N°2017-0110. Cameroonian National Ethics Committee for Human Health Research N°2018/07/1083/CE/CNERSH/SP.

Training, Supervision, and Competence Assessment of Cameroonian Health Care Providers Using HPV Self-Sampling, Triage by Visual Inspection, and Treatment by Thermal Ablation in a Single Visit.

Background: Developing human resource capacity and efficient deployment of skilled personnel are essential for cervical cancer screening program implementation in resource-limited countries. Our aim was to provide a context-specific training framework, supervision, and effectiveness evaluation of health care providers in a cervical cancer screening program. Methods: A 5-year cervical cancer screening program was implemented in Dschang, West Cameroon. Women were invited to perform human papillomavirus self-sampling (Self-HPV), followed by triage using visual inspection with acetic acid (VIA) and thermal ablation if needed. Health care providers were trained in four key learning phases to perform counseling, screening, and treatment process in a single visit. Training included (i) a 3-day basic course, (ii) 3-day advanced practical training, (iii) 2 weeks of supervision, and (iv) bi-monthly supervision by a mentor. The diagnostic performance of health care providers was compared between two time periods, period I (September 2018 to April 2019) and period II (May 2019 to January 2020), for an overall 17-month study period. Results: Fourteen health care providers were recruited for the training course and 12 of them completed the training objectives. Follow-up and evaluations were conducted for three health care providers working in the screening unit at Dschang District Hospital. During the study period, 1,609 women performed Self-HPV, among which 759 were screened during period I and 850 during period II. HPV positivity was 18.2 and 17.1%, and VIA positivity was 45.7 and 71.0% in period I and II, respectively. VIA sensitivity was 60.0% (95% confidence interval [CI] 26.2-87.8) and 80.8% (95% CI 60.6-93.4) in period I and II, respectively (p = 0.390). VIA specificity decreased between period I (57.4, 95% CI 48.1-66.3) and II (30.8, 95% CI 22.6-40.0) (p < 0.001). Health care providers demonstrated substantial agreement with their mentor in their diagnoses during both periods (period I: Cohen's kappa coefficient [k] = 0.73, 95% CI 0.62-0.85, and period II: k = 0.62 0.47-0.76; p = 0.0549). Discussion: Training, supervision, and a focus on effectiveness in cervical cancer screening are interventions that contribute to improving frontline provider competencies and maintaining a high quality of health care service delivery.

Fast-Track in Minimally Invasive Gynecology: A Randomized Trial Comparing Costs and Clinical Outcomes.

Study Objective: Evaluate the effects of a fast-track (FT) protocol on costs and post-operative recovery. Methods: One hundred and seventy women undergoing total laparoscopic hysterectomy for a benign indication were randomized in a FT protocol or a usual care protocol. A FT protocol included the combination of minimally invasive surgery, analgesia optimization, early oral refeeding and rapid mobilization of patients was compared to a usual care protocol. Primary outcome was costs. Secondary outcomes were length of stay, post-operative morbidity and patient satisfaction. Main Results: The mean total cost in the FT group was 13,070 ± 4,321 Euros (EUR) per patient, and that in the usual care group was 3.5% higher at 13,527 ± 3,925 EUR (p = 0.49). The FT group had lower inpatient surgical costs but higher total ambulatory costs during the first post-operative month. The mean hospital stay in the FT group was 52.7 ± 26.8 h, and that in the usual care group was 20% higher at 65.8 ± 33.7 h (p = 0.006). Morbidity during the first post-operative month was not significantly different between the two groups. On their day of discharge, the proportion of patients satisfied with pain management was similar in both groups [83% in FT and 78% in the usual care group (p = 0.57)]. Satisfaction with medical follow-up 1 month after surgery was also similar [91% in FT and 88% in the usual care group (p = 0.69)]. Conclusion: Implementation of a FT protocol in laparoscopic hysterectomy for benign indications has minimal non-significant effects on costs but significantly reduces hospital stay without increasing post-operative morbidity nor decreasing patient satisfaction. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT04839263.

A cross-sectional study exploring triage of human papillomavirus (HPV)-positive women by visual assessment, manual and computer-interpreted cytology, and HPV-16/18-45 genotyping in Cameroon.

BACKGROUND: High-risk human papillomavirus (HPV)-positive women require triage to identify those at higher risk of cervical intraepithelial neoplasia grade 2 or worse (CIN2+). We aimed to compare visual assessment of the cervix, manual cytology and automated cytology as triage tests to screen HPV-positive women, and to assess over-treatment rates after visual assessment and over-referral rates to colposcopy after cytology. METHODS: The present cross-sectional study is nested in a large prospective screening trial in Cameroon. Evaluations of the tests have been conducted individually and in combination with HPV-16/HPV-18/45 genotyping. For the evaluation of over-treatment and colposcopic over-referral, we simulated two screening scenarios: (1) one-visit scenario (test-triage-and-treatment); and (2) two-visit scenario (test-triage-and-colposcopy). RESULTS: 1582 women with a median age of 40 years (IQR 35-45) performed self-sampling for HPV testing, of which 294 (18.6%) were HPV-positive, and 12.2% had CIN2+. Sensitivities for CIN2+ detection were 77.1% for visual assessment, 80.0% for manual cytology, and 84.8% for automated cytology. Sensitivity of combined tests was higher compared with single tests. The highest sensitivity was obtained by the combination of genotyping and automated cytology (91.2%). In the one-visit scenario, the over-treatment rate was 83.9% in referred women, with a ratio of 6.2 treated women per CIN2+. In the two-visit scenario, the lowest over-referral rate would have been under manual cytology (45.0%), with a ratio of 1.8 referred women per CIN2+. Single and combined triage strategies by automated cytology gave rise to over-referral rates of 69.2% and 76.7%, respectively, and a ratio of 3.2 and 4.3 referred women per CIN2+, respectively. DISCUSSION: Triage of HPV-positive women using a combination of genotyping and automated cytology for CIN2+ detection may provide public benefits in low- and middle-income countries.

Cost-effectiveness evaluation of HPV self-testing offered to non-attendees in cervical cancer screening in Switzerland.

OBJECTIVE: About 30% of women who are eligible for cervical cancer (CC) screening remain un-screened or under-screened in Switzerland. HPV testing on self-collected vaginal samples (Self-HPV) has shown to be more sensitive than cytology while also reaching non-attendees. The objective of this study was to explore the cost-effectiveness of offering Self-HPV to non-attendees in Switzerland. METHODS: A recursive decision-tree with one-year cycles was used to model the life-long natural HPV history. Markov cohort simulations were used to assess the expected outcomes from the model. The outcomes of three strategies were compared with the absence of screening: Self-HPV and triage with colposcopy (Self-HPV/colpo), Self-HPV and triage with Pap cytology (Self-HPV/PAP), cytological screening and triage with HPV (PAP/HPV). Sensitivity analyses for the key parameters of the model were conducted to check the robustness of findings. RESULTS: Offering a Self-HPV screening to non-attendees could prevent 90% of CC and 94% of CC-related deaths in the study population. The current cytology-based program could reduce by 83% the number of CC cases and by 88% the number of CC-related deaths over the population's lifetime. Compared to the absence of screening, incremental cost-effectiveness ratios (ICER) were estimated to be, per saved Quality Adjusted Life Year (QALY), 12413US$ for the strategy Self-HPV/colpo, 11138US$ for the strategy Self-HPV/Pap and 22488US$ for the strategy PAP/HPV. CONCLUSIONS: Offering Self-HPV as a CC screening strategy to non-attendees in Switzerland is a cost-effective solution that is associated with a reduction of CC cases and related deaths. Self-HPV is more cost-effective than the currently used cytology-based screening.

Cervical cancer screening in a low-resource setting: a pilot study on an HPV-based screen-and-treat approach.

Cervical cancer (CC) is the leading cause of cancer-related death among women in sub-Saharan Africa, primarily because of limited access to effective screening and preventive treatment. Our aim was to assess the feasibility of a human papillomavirus (HPV)-based CC screen-and-treat approach in a low-resource context. We recruited 1012 women aged 30-49 years through a CC screening campaign conducted in the District Hospital of Dschang, Cameroon. Participants performed HPV self-sampling, which was tested for high-risk HPV (HR-HPV) DNA using the point-of-care Xpert HPV assay. All HPV-positive women were invited for visual inspection with acetic acid and Lugol's iodine (VIA/VILI) to exclude CC or enable triage. A cervical sample for histological analysis was also collected. Women positive for HPV 16/18/45 and for other HR-HPV with pathological VIA/VILI were selected to undergo treatment with thermocoagulation. The HPV prevalence in the study population was 18.5% (n = 187); of these cases, 20 (10.6%), 42 (22.3%) and 140 (74.9%) were positive for HPV16, HPV18/45 and other HR-HPV types, respectively. Overall, 107/185 (57.8%) VIA/VILI examinations were classified as pathological and 78 (42.2%) as normal. Women positive for HPV16/18/45 were 4.2 times more likely to harbor cervical intraepithelial neoplasia grade 2 or worse (CIN2+) than those with other HPV types. The specificity of HPV 16/18/45 genotypes for detection of high-grade lesions among HR-HPV positive women was higher than that of VIA/VILI in all age groups. The sensitivity and specificity of VIA/VILI in detecting CIN2+ among HPV positive women were 80% and 44%, respectively. Overall, 110/121 screen-positive women (90.9%) were eligible for, and were treated with, thermocoagulation. An HPV-based screen-and-treat approach is feasible in a low-resource context and may contribute to improving the effectiveness of CC prevention programs. Immediate thermocoagulation treatment for women who are HPV16- and/or HPV18/45-positive is a practical approach for the treatment of CIN2+. The combination of HPV-testing and VIA/VILI for CC screening might reduce overtreatment.

Usability and feasibility of a mobile health system to provide comprehensive antenatal care in low-income countries: PANDA mHealth pilot study in Madagascar.

Background Madagascar's maternal health mortality ratio in 2013 was 478 deaths per 100,000 live births. Most deaths are related to direct complications during pregnancy and childbirth and could be reduced by providing comprehensive antenatal care (ANC). Objective The objective of the study was to assess the usability and feasibility of a mobile health system (mHealth) to provide high-quality ANC, according to World Health Organization (WHO) recommendations. Methods PANDA (Pregnancy And Newborn Diagnostic Assessment) is an easy-to-use mHealth system that uses affordable communications technology to support diagnosis and health care worker decision-making regarding ANC. From January to March 2015, a cross-sectional pilot study was conducted in Ambanja District, Madagascar, in which ANC using PANDA was provided to 100 pregnant women. The collected data were transmitted to a database in the referral hospital to create individual electronic patient records. Accuracy and completeness of the data were closely controlled. The PANDA software was assessed and the number of abnormal results, treatments performed, and participants requiring referral to health care facilities were monitored. Results The PANDA system facilitated creation of individual electronic patient records that included socio-demographic and medical data for 100 participants. Duration of ANC visits averaged 29.6 min. Health care providers were able to collect all variables (100%) describing personal and medical data. No major technical problems were encountered and no data were lost. During 17 ANC visits (17%), an alert function was generated to highlight abnormal clinical results requiring therapy or referral to an affiliated hospital. Participants' acceptability of the system was very high. Conclusion This pilot study proved the usability and feasibility of the PANDA mHealth system to conduct complete and standardised ANC visits according to WHO guidelines, thus providing a promising solution to increase access to high-quality and standardised ANC for pregnant women in remote areas.

Performance of alternative strategies for primary cervical cancer screening in sub-Saharan Africa: systematic review and meta-analysis of diagnostic test accuracy studies.

OBJECTIVE: To assess and compare the accuracy of visual inspection with acetic acid (VIA), visual inspection with Lugol's iodine (VILI), and human papillomavirus (HPV) testing as alternative standalone methods for primary cervical cancer screening in sub-Saharan Africa. DESIGN: Systematic review and meta-analysis of diagnostic test accuracy studies. DATA SOURCES: Systematic searches of multiple databases including Medline, Embase, and Scopus for studies published between January 1994 and June 2014. REVIEW METHODS: Inclusion criteria for studies were: alternative methods to cytology used as a standalone test for primary screening; study population not at particular risk of cervical cancer (excluding studies focusing on HIV positive women or women with gynaecological symptoms); women screened by nurses; reference test (colposcopy and directed biopsies) performed at least in women with positive screening results. Two reviewers independently screened studies for eligibility and extracted data for inclusion, and evaluated study quality using the quality assessment of diagnostic accuracy studies 2 (QUADAS-2) checklist. Primary outcomes were absolute accuracy measures (sensitivity and specificity) of screening tests to detect cervical intraepithelial neoplasia grade 2 or worse (CIN2+). RESULTS: 15 studies of moderate quality were included (n=61,381 for VIA, n=46,435 for VILI, n=11,322 for HPV testing). Prevalence of CIN2+ did not vary by screening test and ranged from 2.3% (95% confidence interval 1.5% to 3.3%) in VILI studies to 4.9% (2.7% to 7.8%) in HPV testing studies. Positivity rates of VILI, VIA, and HPV testing were 16.5% (9.8% to 24.7%), 16.8% (11.0% to 23.6%), and 25.8% (17.4% to 35.3%), respectively. Pooled sensitivity was higher for VILI (95.1%; 90.1% to 97.7%) than VIA (82.4%; 76.3% to 87.3%) in studies where the reference test was performed in all women (P<0.001). Pooled specificity of VILI and VIA were similar (87.2% (78.1% to 92.8%) v 87.4% (77.1% to 93.4%); P=0.85). Pooled sensitivity and specificity were similar for HPV testing versus VIA (both P ≥ 0.23) and versus VILI (both P ≥ 0.16). Accuracy of VIA and VILI increased with sample size and time period. CONCLUSIONS: For primary screening of cervical cancer in sub-Saharan Africa, VILI is a simple and affordable alternative to cytology that demonstrates higher sensitivity than VIA. Implementation studies are needed to assess the effect of these screening strategies on the incidence and outcomes of cervical cancer in the region.

Clitoral reconstruction after female genital mutilation/cutting: case studies.

INTRODUCTION: Clitoral reconstruction following female genital mutilation/cutting (FGM/C) is a new surgical technique reported to be a feasible and effective strategy to reduce clitoral pain, improve sexual pleasure, and restore a vulvar appearance similar to uncircumcised women. However, data on safety, care offered, and evaluation of sexual and pain outcomes are still limited. AIMS: This study aims to present the care offered and clinical outcomes of two women who received multidisciplinary care, including psychosexual treatment, with clitoral reconstruction. We report their long-term outcomes, and the histology of the removed periclitoral fibrosis. METHODS: We report the cases of two women with FGM/C types II and III who requested clitoral reconstruction for different reasons. One woman hoped to improve her chronic vulvar pain, as well as improve her sexual response. The other woman requested surgery due to a desire to reverse a procedure that was performed without her consent, and a wish to have a genital appearance similar to non infibulated women. They both underwent psychosexual evaluation and therapy and surgery. The histology of the periclitoral fibrosis removed during surgery was analyzed. RESULTS: At 1-year postoperatively, the first woman reported complete disappearance of vulvar pain and improved sexual pleasure, including orgasm. Our second patient also described improved sexuality at 1-year follow-up (increased sexual desire, lubrication, vulvar pleasure, and sensitiveness), which she attributed to a better self body image and confidence. Both women reported feeling satisfied, happy, and more beautiful. CONCLUSION: We show a positive outcome in pain reduction and improved sexual function, self body image, and gender after psychosexual therapy and clitoral reconstruction. More evidence is needed about clitoral reconstruction to develop guidelines on best practices. Until research is conducted that rigorously evaluates clitoral reconstruction for its impact on pain and sexuality, we advise always offering a multidisciplinary care, including sexual therapy before and after the surgery.