Screening test accuracy of portable devices that can be used to perform colposcopy for detecting CIN2+ in low- and middle-income countries: a systematic review and meta-analysis.

BACKGROUND: Portable devices that can be used to perform colposcopy may improve cervical cancer screening in low- and middle-income countries (LMIC) where access to colposcopy is limited. The objective of this study was to systematically review the diagnostic test accuracy (DTA) of these devices for the detection of cervical intraepithelial neoplasia grade 2 or higher (CIN2+). METHODS: In accordance with our protocol (Prospero CRD42018104286), we searched Embase, Medline and the Cochrane Controlled Register of Trials up to 9/2019. We included DTA studies, which investigated portable devices with moderate-to-high optical magnification (≥ 6×) for colposcopy, as described in the manual for Colposcopy and Treatment by the International Agency for Research on Cancer, with a histopathological reference standard. We used the QUADAS-2 tool to assess study quality. We examined results for sensitivity and specificity in paired forest plots, stratified by stages in the clinical pathway. We pooled estimates of test accuracy for the index test, used as an add-on to other tests, using a bivariate random-effect model. RESULTS: We screened 1737 references and assessed 239 full-text articles for eligibility. Five single-gate DTA studies, including 2693 women, met the inclusion criteria. Studies evaluated two devices (Gynocular™ and Pocket) at different stages of the screening pathway. In three studies, which used the index test in an add-on capacity in 1273 women, we found a pooled sensitivity of 0.79 (95% CI 0.55-0.92) and specificity of 0.83 (95% CI 0.59-0.94). The main sources of bias were partial verification, incorporation and classification bias. CONCLUSION: Few studies have evaluated portable devices able to perform colposcopy, so their accuracy for the detection of CIN2+ remains uncertain. Future studies should include patient-relevant and long-term outcomes, including missed cases, overtreatment, residual and recurrent disease. To meet the challenge of eliminating cervical cancer in LMIC, methods for visual assessment of the cervix need urgent redress.

Laparoscopic Pectopexy with Burch Colposuspension for Pelvic Prolapse Associated with Stress Urinary Incontinence.

STUDY OBJECTIVE: To present a case of pelvic organ prolapse associated with stress urinary incontinence treated by laparoscopic pectopexy followed by Burch colposuspension. DESIGN: Case report. SETTING: University Gynecology Clinic of the Emergency Clinical City Hospital Timișoara, Romania. PATIENTS: We present the case of a 41-year-old woman, gravida 1 para 1, with no notable medical or surgical history, with a body mass index of 40 kg/m2, who presented in our service with heavy menstrual bleeding, dysmenorrhea, pelvic pressure, dyspareunia, stress urinary incontinence, and voiding difficulties. Local examination revealed a cervix descended 2 cm below the hymenal ring, cystocele, urethrocele, and a positive cough stress test. The pelvic prolapse was classified as pelvic organ prolapse quantification stage 3. Ultrasound exam revealed a uterus with diffuse adenomyosis of the posterior uterine wall and normal adnexa. Because of the patient's obesity, the treatment plan was laparoscopic supracervical hysterectomy for the treatment of adenomyosis, laparoscopic pectopexy for the correction of the apical defect, and Burch colposuspension for the cure of stress incontinence. INTERVENTIONS: The patient was placed in the standard dorsal lithotomy position with the hips in extension and the knees flexed and the table in 45° Trendelenburg position. One 10-mm umbilical optical trocar and three 5-mm trocars were used-2 inserted 2 cm above and medial to the anterior superior iliac crests, and the third, 5 cm below the umbilical trocar. The dissection started on the left side of the pelvis. The peritoneum was incised in the center of a V-shaped area bordered by the left round ligament and the obliterated umbilical artery (the medial umbilical ligament). The soft tissue was dissected, and the left iliopectineal ligament (also known as the inguinal ligament of Cooper) was identified right under the external iliac vein and prepared. The same steps were repeated on the right side of the pelvis. The procedure continued with the dissection of the vesicovaginal space. The anterior vaginal wall was exposed with the help of a retractor placed inside the vagina and held by an assistant. A supracervical hysterectomy was performed. An 8 × 15-cm polypropylene mesh, cut in a T shape, was introduced in the abdomen. First, the short arm of the T was fixed on the anterior vaginal wall using multiple absorbable tacks (AbsorbaTack fixation device; Medtronic, Dublin, Ireland). To use a type of nonabsorbable fixation, we decided to also fix the mesh to the cervix stump with 3 isolated stitches (Silk Suture 2-0; Ethicon, Somerville, NJ). Second, with the purpose of ensuring a permanent fixation, the lateral arms of the mesh were attached to the iliopectineal ligaments with multiple nonabsorbable tacks on both sides (ProTack fixation device; Medtronic, Dublin, Ireland). The procedure continued with the complete closure of the peritoneum with VICRYL 2-0 sutures (Ethicon). Because the patient also had stress urinary incontinence, a Burch colposuspension was performed. To expose its limits, the urinary bladder was filled with 200 mL of saline. After the incision of the peritoneum, the avascular space of Retzius was opened. The dissection continued until the Cooper's ligaments were exposed bilaterally. The proper suture placement points on the vaginal wall were facilitated by an assistant's intravaginal finger. Two isolated nonabsorbable silk stitches (Silk Suture 2-0) were placed through the Cooper's ligament and through the anterior vaginal wall on each side. The knots were tied just enough to properly lift the vaginal wall in the normal position, assessed by the assistant by vaginal route, but not too tight to avoid urethral obstruction. MEASUREMENTS AND MAIN RESULTS: The duration of the surgery was 95 minutes, with minimal blood loss of about 60 mL. The patient recovered well, with the Foley catheter being removed after 12 hours. The patient was discharged after 48 hours. The 6-month follow-up examination revealed a correct anatomical position of the anterior vaginal wall and of the cervix at 6 cm above the hymenal ring and no urinary incontinence. CONCLUSION: Laparoscopic pectopexy represents a new option for the treatment of pelvic organ prolapse. In the case we reported, no intraoperative or postoperative complications were present, and the follow-up assessment revealed an effective correction of the prolapse. Further studies are needed to conclude the efficiency and safety of this new procedure.

Molecular detection of oncogenic subtypes of human papillomavirus (HPV) in a group of women in the Amazon region of Brazil

The natural history of cervical cancer is strongly related to the presence of human papillomavirus (HPV) infection, with its relationship with cervical cancer being a matter of concern. It is estimated that 70% of all cervical cancers worldwide are caused by HPV 16 and 18. Accordingly, the present study aimed to contribute to the identification of HPV subtypes circulating in a group of women of Manaus-Brazil. Cervical samples were collected from 49 women, following the eligibility criteria of the study, and DNA was then extracted from the samples, which were analyzed for the presence of the virus in the genetic material through the polymerase chain reaction (PCR) using generic primers (GP05/06). Finally, identification of the viral subtypes was performed using specific primers for the detection of the main subtypes already examined (16 and 18). Positive HPV DNA was detected in 100% of the samples included in the study. Human papillomavirus 16 was the most prevalent subtype in the majority of lesions, accounting for 29 (59.2%) of the positive cases, and HPV 18 was detected in four (8.2%) women. In these 4 cases there was co-infection, with the presence of both HPV 18 and HPV 16. Therefore, 40.8% (20 cases) in which HPV DNA was detected presented infection with other subtypes of HPV not included in the study. This data has clinical implications related to cervical cancer prevention, as the current prophylactic HPV vaccines are only effective against high-risk HPV 16 and 18 subtypes.

Outcomes of a Staged Midurethral Sling Strategy for Stress Incontinence and Pelvic Organ Prolapse.

OBJECTIVE: To evaluate the proportion of women who experienced resolution of stress urinary incontinence (SUI) symptoms after surgery for pelvic organ prolapse (POP) without a concomitant incontinence procedure. METHODS: We conducted a retrospective observational study of women with preoperative subjective and objective SUI who underwent minimally invasive sacrocolpopexy or uterosacral ligament suspension from 2009 to 2015. We excluded cases with incontinence procedures. The primary outcome was the proportion of women with subjective resolution of SUI postoperatively, defined as the absence of patient reported SUI symptoms during follow-up. Secondary outcomes included the proportion of women who underwent a subsequent staged midurethral sling (MUS) procedure and factors associated with resolution of SUI and staged MUS placement. RESULTS: Of 93 women, most were white (n=90, 98%) with stage III POP (n=55, 59%). Mean age was 59.5±8.9 years and body mass index 28.7±4.7. Seventy-three patients (78%) underwent minimally invasive sacrocolpopexy, and 20 (22%) underwent uterosacral ligament suspension. Median follow-up was 8.3 months (interquartile range 3.4-26.7). Postoperatively, 28 (30%) patients reported resolution of SUI, and 65 (70%) reported persistent SUI. Of the 93 patients, 47 (51%) were treated for persistent SUI and 34 (37%) underwent a staged MUS procedure. Among the staged MUS procedures, 27 (79%) were placed within 12 months. Median time to staged MUS procedure was 5.5 months (interquartile range 4.2-9.9). After controlling for degree of preoperative SUI bother, obese women were less likely to experience resolution of SUI after prolapse repair (odds ratio 0.28, 95% CI 0.08-0.95). We did not identify any factors that were significantly associated with undergoing a staged MUS procedure on univariate analyses (P>.05). CONCLUSION: Preoperative SUI resolved in nearly a third of women after prolapse surgery without a concomitant incontinence procedure. In a population typically offered a concomitant MUS procedure at the time of prolapse repair, a staged approach may result in nearly two-thirds fewer patients undergoing MUS procedures. This information may be helpful during preoperative shared decision making.

Safety and efficacy of spider anchoring device for apical repair in laparoscopic sacrocolpopexy: Retrospective cohort study.

OBJECTIVE: The aim of the study was to assess safety and efficacy of apical support when using the soft-tissue metal fasteners of EndoFast Reliant™ SCP during laparoscopic sacrocolpopexy (LSCP). STUDY DESIGN: This is a single-center, retrospective cohort study including all patients which underwent LSCP between 2015 and 2017. Safety outcome included the procedure and the device related complications. Effectiveness outcomes included the anatomical success of apical repair and the functional results as were obtained from the clinic and from a Quality of life questionnaire (PFDI-20). RESULTS: Eighty-four patients, 54% with grade III and IV prolapse were included in the study. Uterus was preserved in 68% of patients with uterus. Mean follow-up period for the clinic visit was 4.5 ± 4 months. Short term anatomical success was achieved for 98.8% of the patients. Marked improvement was observed in the related symptoms including urinary incontinence. Three intra-operative complications occurred: 1 case of bladder injury, 1 case of intra-abdominal bleeding, and 1 case of post-operative vaginal bleeding. Later complications included only two patients (2.3%) complained of chronic abdominal pain. There were no cases of mesh erosion or de-novo dyspareunia. The mean follow-up period for the PFDI-20 questionnaire was 15.6 months. 75% of patients had no bulge symptoms at all. Quarter of the patients had some bulge symptoms, bothers them between somewhat to moderately according to the questionnaire grading. CONCLUSIONS: The use of Endofast SCP fasteners for laparoscopic promonto-fixation is a safe and effective surgery. Longer follow-up and larger studies should be performed to establish the results.

A mobile-phone based high-resolution microendoscope to image cervical precancer.

Nearly 90% of cervical cancer cases and deaths occur in low- and middle-income countries that lack comprehensive national HPV immunization and cervical cancer screening programs. In these settings, it is difficult to implement screening programs due to a lack of infrastructure and shortage of trained personnel. Screening programs based on visual inspection with acetic acid (VIA) have been successfully implemented in some low-resource settings. However, VIA has poor specificity and up to 90% of patients receiving treatment based on a positive VIA exam are over-treated. A number of studies have suggested that high-resolution cervical imaging to visualize nuclear morphology in vivo can improve specificity by better distinguishing precancerous and benign lesions. To enable high-resolution imaging in low-resource settings, we developed a portable, low-cost, high-resolution microendoscope that uses a mobile phone to detect and display images of cervical epithelium in vivo with subcellular resolution. The device was fabricated for less than $2,000 using commercially available optical components including filters, an LED and triplet lenses assembled in a 3D-printed opto-mechanical mount. We show that the mobile high-resolution microendoscope achieves similar resolution and signal-to-background ratio as previously reported high-resolution microendoscope systems using traditional cameras and computers to detect and display images. Finally, we demonstrate the ability of the mobile high-resolution microendoscope to image normal and precancerous squamous epithelium of the cervix in vivo in a gynecological referral clinic in Barretos, Brazil.

Evaluation of portable colposcopy and human papillomavirus testing for screening of cervical cancer in rural China.

OBJECTIVE: To evaluate the use of a portable, rechargeable colposcope combined with human papillomavirus (HPV) testing, as compared with HPV testing alone, for screening of cervical cancer and pre-cancerous lesions. METHODS: This was a cross-sectional study among 488 women in Baoshan County, Yunnan. The women underwent HPV testing followed by Gynocular portable colposcopy with visual inspection with acetic acid. Obvious lesions were biopsied. If portable colposcopy testing was negative but HPV testing was positive, the women underwent follow-up testing with thin-prep cytology and traditional colposcopy. Cervical biopsies were performed for any abnormalities. Histopathology was followed up with diagnosis and treatment. RESULTS: Among 488 women screened with portable colposcopy, 24 women underwent biopsy based on positive colposcopy screening. Of these 24 women, three were HPV positive and 21 were HPV negative. Five women had cervical intra-epithelial neoplasia (CIN) I and one had advanced cervical cancer. Forty-six women tested positive for HPV. Three of these women had screened positive on preliminary colposcopy, with one positive for CIN III/squamous cell carcinoma and one woman with CIN I. Forty-three women underwent follow-up testing with thin-prep cytology. Two women had atypical squamous cells of undetermined significance and five had low-grade squamous intra-epithelial lesions and were biopsied; three women had CIN I, one had CIN II and one had CIN III. HPV testing and portable colposcopy was more sensitive but slightly less specific than portable colposcopy or HPV testing alone. CONCLUSION: While HPV testing has high sensitivity and specificity for the detection of pre-cancerous and cancerous lesions and portable colposcopy has lower specificity, both methods of detection have low positive predictive value and high negative predictive value. In tandem, HPV testing and portable colposcopy had higher sensitivity for detection among women who underwent biopsies. In clinical practice, portable colposcopy was an effective, easy and affordable tool to transport to villages where cytology is not currently feasible.

Prevalencia de lesiones intraepiteliales cervicales de bajo y alto grado en pacientes en edad fértil. Maracaibo. Estado Zulia / Prevalence of intrepelitelial, cervical low and high grade injuries in patients in the fertile age. Maracaibo. Zulia state

Determinar la prevalencia de las lesiones intraepiteliales cervicales de bajo y alto grado en pacientes de edad fértil en la consulta de ginecología del centro Materno pediatrico Zulia, en el período comprendido febrero 2016 -febrero 2018 Maracaibo, Estado Zulia. Métodos: Se realizó un estudio descriptivo retrospectivo en el que se incluyeron mujeres entre los 15 y 44 años, que acudieron a la consulta de Ginecología obstetricia del centro materno pediátrico Zulia para el periodo comprendido febrero 2016 ­ febrero 2018. Se evaluó la normalidad de las variables cuantitativas, empleándose la mediana o el promedio con sus varianzas según su distribución, y frecuencias y proporciones para las variables categóricas. Resultados: Se incluyeron 150 pacientes. La mediana de la edad fue 29 años con rango (R: 15-43 años), la mediana del número de partos 1 (R: 0-3). Uso de métodos anticonceptivos, la mayoría utilizaba ACO. El 60% de las citologías se reportaron como negativas, 20 % lesión de bajo grado (LSIL), 10% células escamosas atípicas de significado indeterminado (ASC-US), 2% lesiones de alto grado (HSIL), 2,3% células escamosas atípicas de significado indeterminado de alto grado ASC-H, 3,3% células glandulares atípicas de significado incierto (ASGUS) y 2% carcinoma invasor. Conclusión: La prevalencia de las anormalidades citológicas fue alta en todos los grupos analizados, sin embargo, existe un mayor número de LSIL hacia la tercera década de la vida y en aquellas que iniciaron su vida sexual después de los 40 años. De igual manera se encontró una relación inversa entre el número de partos, planificación familiar hormonal y aparición de lesiones pre neoplásicas(AU)

To determine the prevalence of cervical intraepithelial lesions of low and high grade in patients of fertile age in the gynecology clinic of the Zulia maternity center, in the period February 2016-February 2018 Maracaibo, Zulia State. Methods: A retrospective descriptive study was carried out that included women between 15 and 44 years old, who attended the obstetrics gynecology clinic of the Zulia pediatric maternity center for the period February 2016-February 2018. The normality of the quantitative variables, using the median or average with their variances according to their distribution, and frequencies and proportions for the categorical variables. Results: 150 patients were included. the median age was 29 years with range (R: 15-43 years), the median number of births 1 (R: 0-3). Using contraceptive methods, most used ACO. 60% of cytologies were reportedas negative, 20% low grade lesion (LSIL), 10% atypical squamous cells of undetermined significance (ASC-US), 2% high grade lesions (HSIL), 2.3% cells Atypical squamous of indeterminate significance of high grade ASC-H, 3.3% atypical glandular cells of uncertain significance (ASGUS) and 2% invasive carcinoma. Conclusion: The prevalence of cytological abnormalities was high in all the groups analyzed, however, there is a greater number of LSIL in the third decade of life and in those who began their sexual life their 40 years. Likewise, an inverse relationship was found between the number of births, hormonal family planning and the appearance of pre-neoplastic lesions(AU)

Adjunctive colposcopy technologies for assessing suspected cervical abnormalities: systematic reviews and economic evaluation.

BACKGROUND: Dynamic Spectral Imaging System (DySIS)map (DySIS Medical Ltd, Edinburgh, UK) and ZedScan (Zilico Limited, Manchester, UK) can be used adjunctively with conventional colposcopy, which may improve the detection of cervical intraepithelial neoplasia (CIN) and cancer. OBJECTIVES: To systematically review the evidence on the diagnostic accuracy, clinical effectiveness and implementation of DySISmap and ZedScan as adjuncts to standard colposcopy, and to develop a cost-effectiveness model. METHODS: Four parallel systematic reviews were performed on diagnostic accuracy, clinical effectiveness issues, implementation and economic analyses. In January 2017 we searched databases (including MEDLINE and EMBASE) for studies in which DySISmap or ZedScan was used adjunctively with standard colposcopy to detect CIN or cancer in women referred to colposcopy. Risk of bias was assessed with the Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2 tool. Summary estimates of diagnostic accuracy were calculated using bivariate and other regression models when appropriate. Other outcomes were synthesised narratively. A patient-level state-transition model was developed to evaluate the cost-effectiveness of DySISmap and ZedScan under either human papillomavirus (HPV) triage or the HPV primary screening algorithm. The model included two types of clinics ['see and treat' and 'watchful waiting' (i.e. treat later after confirmatory biopsy)], as well as the reason for referral (low-grade or high-grade cytological smear). Sensitivity and scenario analyses were undertaken. RESULTS: Eleven studies were included in the diagnostic review (nine of DySISmap and two of ZedScan), three were included in the clinical effectiveness review (two of DySISmap and one of ZedScan) and five were included in the implementation review (four of DySISmap and one of ZedScan). Adjunctive DySISmap use was found to have a higher sensitivity for detecting CIN grade 2+ (CIN 2+) lesions [81.25%, 95% confidence interval (CI) 72.2% to 87.9%] than standard colposcopy alone (57.91%, 95% CI 47.2% to 67.9%), but with a lower specificity (70.40%, 95% CI 59.4% to 79.5%) than colposcopy (87.41%, 95% CI 81.7% to 91.5%). (Confidential information has been removed.) The base-case cost-effectiveness results showed that adjunctive DySISmap routinely dominated standard colposcopy (it was less costly and more effective). The only exception was for high-grade referrals in a watchful-waiting clinic setting. The incremental cost-effectiveness ratio for ZedScan varied between £272 and £4922 per quality-adjusted life-year. ZedScan also dominated colposcopy alone for high-grade referrals in see-and-treat clinics. These findings appeared to be robust to a wide range of sensitivity and scenario analyses. LIMITATIONS: All but one study was rated as being at a high risk of bias. There was no evidence directly comparing ZedScan with standard colposcopy. No studies directly compared DySIS and ZedScan. CONCLUSIONS: The use of adjunctive DySIS increases the sensitivity for detecting CIN 2+, so it increases the number of high-grade CIN cases that are detected. However, it also reduces specificity, so that more women with no or low-grade CIN will be incorrectly judged as possibly having high-grade CIN. The evidence for ZedScan was limited, but it appears to increase sensitivity and decrease specificity compared with colposcopy alone. The cost-effectiveness of both adjunctive technologies compared with standard colposcopy, under both the HPV triage and primary screening algorithms, appears to be favourable when compared with the conventional thresholds used to determine value in the NHS. FUTURE WORK: More diagnostic accuracy studies of ZedScan are needed, as are studies assessing the diagnostic accuracy for women referred to colposcopy as part of the HPV primary screening programme. STUDY REGISTRATION: This study is registered as PROSPERO CRD42017054515. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Portable Pocket colposcopy performs comparably to standard-of-care clinical colposcopy using acetic acid and Lugol's iodine as contrast mediators: an investigational study in Peru.

OBJECTIVE: Our goal was to develop a tele-colposcopy platform for primary-care clinics to improve screening sensitivity and access. Specifically, we developed a low-cost, portable Pocket colposcope and evaluated its performance in a tertiary healthcare centre in Peru. DESIGN AND SETTING: Images of the cervix were captured with a standard-of-care and Pocket colposcope at la Liga Contra el Cáncer in Lima, Peru. POPULATION: Two hundred Peruvian women with abnormal cytology and/or human papillomavirus positivity were enrolled. METHODS: Images were collected using acetic acid and Lugol's iodine as contrast agents. Biopsies were taken as per standard-of-care procedures. MAIN OUTCOME MEASURES: After passing quality review, images from 129 women were sent to four physicians who provided a diagnosis for each image. RESULTS: Physician interpretation of images from the two colposcopes agreed 83.1% of the time. The average sensitivity and specificity of physician interpretation compared with pathology was similar for the Pocket (sensitivity = 71.2%, specificity = 57.5%) and standard-of-care (sensitivity = 79.8%, specificity = 56.6%) colposcopes. When compared with a previous study where only acetic acid was applied to the cervix, results indicated that adding Lugol's iodine as a secondary contrast agent improved the percent agreement between colposcopes for all pathological categories by up to 8.9% and the sensitivity and specificity of physician interpretation compared with pathology by over 6.0 and 9.0%, respectively. CONCLUSIONS: The Pocket colposcope performance was similar to that of a standard-of-care colposcope when used to identify precancerous and cancerous lesions using acetic acid and Lugol's iodine during colposcopy examinations in Peru. TWEETABLE ABSTRACT: The Pocket colposcope performance was similar to that of a standard-of-care colposcope when identifying cervical lesions.

An integrated strategy for improving contrast, durability, and portability of a Pocket Colposcope for cervical cancer screening and diagnosis.

INTRODUCTION: We have previously developed a portable Pocket Colposcope for cervical cancer screening in resource-limited settings. In this manuscript we report two different strategies (cross-polarization and an integrated reflector) to improve image contrast levels achieved with the Pocket Colposcope and evaluate the merits of each strategy compared to a standard-of-care digital colposcope. The desired outcomes included reduced specular reflection (glare), increased illumination beam pattern uniformity, and reduced electrical power budget. In addition, anti-fogging and waterproofing features were incorporated to prevent the Pocket Colposcope from fogging in the vaginal canal and to enable rapid disinfection by submersion in chemical agents. METHODS: Cross-polarization (Generation 3 Pocket Colposcope) and a new reflector design (Generation 4 Pocket Colposcope) were used to reduce glare and improve contrast. The reflector design (including the angle and height of the reflector sidewalls) was optimized through ray-tracing simulations. Both systems were characterized with a series of bench tests to assess specular reflection, beam pattern uniformity, and image contrast. A pilot clinical study was conducted to compare the Generation 3 and 4 Pocket Colposcopes to a standard-of-care colposcope (Leisegang Optik 2). Specifically, paired images of cervices were collected from the standard-of-care colposcope and either the Generation 3 (n = 24 patients) or the Generation 4 (n = 32 patients) Pocket Colposcopes. The paired images were blinded by device, randomized, and sent to an expert physician who provided a diagnosis for each image. Corresponding pathology was obtained for all image pairs. The primary outcome measures were the level of agreement (%) and κ (kappa) statistic between the standard-of-care colposcope and each Pocket Colposcope (Generation 3 and Generation 4). RESULTS: Both generations of Pocket Colposcope had significantly higher image contrast when compared to the standard-of-care colposcope. The addition of anti-fog and waterproofing features to the Generation 3 and 4 Pocket Colposcope did not impact image quality based on qualitative and quantitative metrics. The level of agreement between the Generation 3 Pocket Colposcope and the standard-of-care colposcope was 75.0% (kappa = 0.4000, p = 0.0028, n = 24). This closely matched the level of agreement between the Generation 4 Pocket Colposcope and the standard-of-care colposcope which was also 75.0% (kappa = 0.4941, p = 0.0024, n = 32). CONCLUSION: Our results indicate that the Generation 3 and 4 Pocket Colposcopes perform comparably to the standard-of-care colposcope, with the added benefit of being low-cost and waterproof, which is ideal for use in resource-limited settings. Additionally, the reflector significantly reduces the electrical requirements of the Generation 4 Pocket Colposcope enhancing portability without altering performance compared to the Generation 3 system.

Examination of the pediatric adolescent patient.

Gynecologic examination of the pediatric adolescent patient provides a valuable opportunity for patient education and diagnosis, yet presents special challenges, including achieving comfort for the patient and guardian and finding equipment that are sized for pediatric patient. Anatomic changes due to the hormonal environment evolve from newborn through pubertal development. As pediatric adolescent gynecology has evolved as a specialty, techniques and training for providing optimal office and surgical examination have emerged. Where possible, the patient should be engaged with the examination through use of a mirror or positioning. Smaller swabs should be used for testing for vaginal infection in prepubertal patients. When speculum or office examination is not possible, use of narrow-caliber, flexible, and rigid hysteroscopes allow vaginoscopy for assessment.

Effects of Pneumoperitoneum and the Steep Trendelenburg Position on Heart Rate Variability and Cerebral Oxygenation during Robotic Sacrocolpopexy.

STUDY OBJECTIVE: The aim of this study was to investigate how steep Trendelenburg positioning with pneumoperitoneum modifies brain oxygenation and autonomic nervous system modulation of heart rate variability during robotic sacrocolpopexy. DESIGN: Prospective study (Canadian Task Force classification III). SETTING: Rambam Health Care Campus. PATIENTS: Eighteen women who underwent robotic sacrocolpopexy for treatment of uterovaginal or vaginal apical prolapse. INTERVENTIONS: Robotic sacrocolpopexy. MEASUREMENTS AND MAIN RESULTS: A 5-minute computerized electrocardiogram, cerebral O2 saturation (cSO2), systemic O2 saturation, heart rate (HR), diastolic blood pressure (BP), systolic BP, and end-tidal CO2 tension were recorded immediately after anesthesia induction (baseline phase) and after alterations in positioning and in intra-abdominal pressure. HR variability was assessed in time and frequency domains. Cerebral oxygenation was measured by the technology of near-infrared spectrometry. cSO2 at baseline was 73% ± 9%, with minor and insignificant elevation during the operation. Mean HR decreased significantly when the steep Trendelenburg position was implemented (66 ± 10 vs 55 ± 9 bpm, p < .05) and returned gradually to baseline with advancement of the operation and the decrease in intra-abdominal pressure. Concomitant with this decrease, the power of both arms of the autonomic nervous system increased significantly (2.8 ± .8 vs 3.3 ± .9 ms2/Hz and 2.5 ± 1.2 vs 3.2 ± .9 ms2/Hz, respectively, p < .05). All these effects occurred without any significant shifts in systolic or diastolic BP or in systemic or cerebral oxygenation. CONCLUSION: This study supports the safety of robotic sacrocolpopexy performed with steep Trendelenburg positioning with pneumoperitoneum. Only minor alterations were observed in cerebral oxygenation and autonomic perturbations, which did not cause clinically significant alterations in HR rate and HR variability.

Effect of mesh width on apical support after sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: We evaluated the effect of polypropylene mesh width on vaginal apical support, mesh elongation, and mesh tensile strength for abdominal sacrocolpopexy. METHODS: Abdominal sacrocolpopexy was performed on ten cadavers using pieces of polypropylene mesh of width 1, 2, and 3 cm. Weights of 1, 2, 3, and 4 kg were sequentially applied to the vagina. The total distance moved by the vaginal apex, and the amount of stretch of the intervening mesh segment between the sacrum and the vagina were recorded for each width. The failure strengths of additional single and double layer sets of each width were also tested using a tensiometer. Data were analyzed with analysis of variance using a random effects model. RESULTS: The mean (standard error of the mean) maximum distance moved by the vaginal apex was 4.63 cm (0.37 cm) for the 1 cm mesh compared to 3.67 cm (0.26 cm) and 2.73 cm (0.14 cm) for the 2 and 3 cm meshes, respectively (P < 0.0001). The 1 cm width ruptured during testing in four of the ten cadavers. The results were similar for mesh elongation, with the 1 cm mesh stretching the most and the 3 cm mesh stretching the least. Mesh failure loads for double-layer mesh were 52.9 N (2.5 N), 124.4 N (2.7 N), and 201.2 N (4.5 N) for the 1, 2, and 3 cm meshes, respectively, and were higher than the failure loads for single mesh (P < 0.001). CONCLUSIONS: In a cadaver model, increasing mesh width is associated with better vaginal apical support, less mesh elongation, and higher failure loads. Mesh widths of 2-3 cm provide sufficient repair strength for sacrocolpopexy.

Peek's harpoon: a new device for the treatment of laparoscopic sacropexy. Preliminary study in unembalmed cadavers.

INTRODUCTION AND HYPOTHESIS: The aim of the study is to facilitate the suture on the sacral promontory for laparoscopic sacrocolpopexy. We hypothesised that a new method of sacral anchorage using a biosynthetic material, the polyether ether ketone (PEEK) harpoon, might be adequate because of its tensile strength, might reduce complications owing to its well-known biocompatibility, and might shorten the duration of surgery. METHODS: We verified the feasibility of insertion and quantified the stress resistance of the harpoons placed in the promontory in nine fresh cadavers, using four stress tests in each case. Mean values were analysed and compared using the Wilcoxon and Fisher's exact tests. RESULTS: The harpoon resists for at least 30 s against a pulling force of 1 N, 5 N and 10 N. Maximum tensile strength is 21 N for the harpoon and 32 N for the suture. Harpoons broke in 6 % and threads in 22 % of cases. Harpoons detached owing to ligament rupture in 64 % of the cases. Regarding failures of the whole complex, the failure involves the harpoon in 92 % of cases and the thread in 56 %. The four possible placements of the harpoon in the promontory were equally safe in terms of resistance to traction. CONCLUSIONS: The PEEK harpoon can be easily anchored in the promontory. Thread is more resistant to traction than the harpoon, but the latter makes the surgical technique easier. Any of the four locations tested is feasible for anchoring the device.

Deficiencia de micronutrientes en la dieta del paciente con lesiones precancerosas del cérvix de una clínica de colposcopía en Ciudad Juárez, México / Micronutrient deficiency in the diet of the patient with precancerous cervix lesions on a colposcopy clinic at Ciudad Juárez, Mexico

Introducción: las lesiones intraepiteliales escamosas (LIE) son un estado de transición hacia el cáncer cervicouterino (CaCu) y un déficit de cronutrientes puede acelerar este proceso. Por ello, determinar la existencia de este déficit y conocer qué factores se asocian permitiría una posible prevención en esta población de riesgo. Objetivo: determinar la presencia de alguna deficiencia de micronutrientes involucrados en el proceso anticancerígeno y asociar este déficit con hábitos y factores demográficos en pacientes con LIE de Ciudad Juárez, Chihuahua, México. Métodos: en un estudio transversal analítico fueron seleccionadas 102 pacientes con LIE. Se realizó una encuesta dietaría (recordatorio de 24 horas) para estimar la ingesta de micronutrientes. La deficiencia fue determinada con un consumo < 75% de la ingesta diaria recomendada o sugerida (IDR o IDS) en México. Algunos hábitos y factores demográficos fueron obtenidos mediante la entrevista con la paciente. Se realizó un modelo de regresión logística para asociar la presencia de deficiencia con factores que afectan a la ingesta o incrementan el requerimiento de micronutrientes. Resultados: el retinol, ácido fólico, zinc, vitaminas C y E, considerados como micronutrientes en el proceso anticancerígeno del CaCu, se encontraron por debajo del 75% de la IDR. Aquellas mujeres con sobrepeso, obesidad y amas de casa se asociaron significativamente con la deficiencia de micronutrientes. Conclusión: el sobrepeso, la obesidad y la ocupación han sido asociados para presentar deficiencias de micronutrientes en este estudio. Estas variables convergen en una posible inseguridad alimentaria, la cual podría asociarse al incremento de incidencia de CaCu en México (AU)

Introduction: Squamous Intraepithelial Lesions (SIL) is a state of transition to cervical cancer (CC), and micronutrient deficiencies can speed up this process. Therefore, determining the existence of this deficit and know what factors are associated would allow for possible prevention in this population at risk. Objective: To determine the presence of some micronutrient deficiencies involved in the anti-carcinogenic process, also associate this deficit with habits and demographic factors in patients with SIL in Ciudad Juarez, Chihuahua, Mexico. Methods: An analytic cross-sectional study, 102 patients were selected with SIL. A dietary survey (24-hour recall) was performed to estimate the intake of micronutrients. The deficiency was determined when the consumption was less than 75% of the Recommended Dietary Allowances (RDA) or suggested in Mexico. Some habits and demographic factors were obtained by interview with the patient. A logistic regression was performed to associate the presence of deficiencies with factors that affecting the intake or increase the requirement of micronutrients. Results: Retinol, folic acid, zinc, vitamins C and E, considered micronutrients in the anti-carcinogenic process CC, were less than 75% of the RDA. Women with overweight, obesity and housewives, were significantly associated with micronutrient deficiencies. Conclusion: Overweight, obesity and occupation have been associated to present micronutrient deficiencies in this study. These variables converge on a possible food insecurity, which could be associated with increased incidence of CC in Mexico (AU)

Application of a Telecolposcopy Program in Rural Settings.

BACKGROUND: Individuals in rural areas are often restricted by the amount of physicians' availability, thus limiting access to healthcare in those settings. INTRODUCTION: While Pap smear screening has increased across the United States, the rural South still reports high rates of cervical cancer and mortality. One solution to improve patient outcomes related to cervical cancer in rural settings is telecolposcopy. MATERIALS AND METHODS: Women with abnormal Pap results or an abnormal visual examination needing an evaluation by colposcopy were referred to a hospital-based telecolposcopy program. Descriptive data are provided that include patients' access to care based on travel time and transportation costs. RESULTS: Over a 15-month time period, 940 unique patients were seen using telecolposcopy. Telecolposcopy was done at eight spoke sites across Arkansas representing patients from 72 of the 75 counties. Data for risk factors that include smoking, first sexual experience, and number of sexual partners in past 12 months and in a lifetime are discussed. Pap results and impression are provided. In addition, avoided transportation costs and travel time have been calculated and included. DISCUSSION: Cervical cancer is important public health concern especially for women residing in rural areas. We were able to demonstrate that our telecolposcopy program has provided sustainability statewide since its inception and that patients are willing to participate. In addition to providing increased access to care, the program also reduced travel time and costs associated with a face-to-face visit. CONCLUSION: Telecolposcopy should be further explored and utilized in rural settings as a way to reduce patient costs and improve cervical cancer outcomes.

Design of a Novel Low Cost Point of Care Tampon (POCkeT) Colposcope for Use in Resource Limited Settings.

INTRODUCTION: Current guidelines by WHO for cervical cancer screening in low- and middle-income countries involves visual inspection with acetic acid (VIA) of the cervix, followed by treatment during the same visit or a subsequent visit with cryotherapy if a suspicious lesion is found. Implementation of these guidelines is hampered by a lack of: trained health workers, reliable technology, and access to screening facilities. A low cost ultra-portable Point of Care Tampon based digital colposcope (POCkeT Colposcope) for use at the community level setting, which has the unique form factor of a tampon, can be inserted into the vagina to capture images of the cervix, which are on par with that of a state of the art colposcope, at a fraction of the cost. A repository of images to be compiled that can be used to empower front line workers to become more effective through virtual dynamic training. By task shifting to the community setting, this technology could potentially provide significantly greater cervical screening access to where the most vulnerable women live. The POCkeT Colposcope's concentric LED ring provides comparable white and green field illumination at a fraction of the electrical power required in commercial colposcopes. Evaluation with standard optical imaging targets to assess the POCkeT Colposcope against the state of the art digital colposcope and other VIAM technologies. RESULTS: Our POCkeT Colposcope has comparable resolving power, color reproduction accuracy, minimal lens distortion, and illumination when compared to commercially available colposcopes. In vitro and pilot in vivo imaging results are promising with our POCkeT Colposcope capturing comparable quality images to commercial systems. CONCLUSION: The POCkeT Colposcope is capable of capturing images suitable for cervical lesion analysis. Our portable low cost system could potentially increase access to cervical cancer screening in limited resource settings through task shifting to community health workers.