Tenofovir alafenamide or tenofovir disoproxil fumarate in pregnancy to prevent HBV transmission: Maternal ALT trajectory and infant outcomes.

BACKGROUND: The use of antiviral agents, specifically tenofovir disoproxil fumarate (TDF), in pregnant women to prevent mother-to-child HBV transmission is a key step towards hepatitis elimination. However, data on using tenofovir alafenamide (TAF) is insufficient. The frequent occurrence of postpartum ALT flares may impact the clinical implementation. METHODS: The maternal and infant outcomes were compared in multi-centre trials of high viral load HBsAg/HBeAg+ pregnant women receiving TAF or TDF from the third trimester until 2 weeks postpartum with intensive follow-ups. To explore the dynamic pre- and postpartum changes in ALT levels, we used a group-based trajectory model for analysing data of 332 women from three prospective studies. RESULTS: After treatment, the maternal HBV DNA levels significantly decreased from baseline to delivery: 7.87 ± 0.59 to 3.99 ± 1.07 Log10 IU/mL TAF (n = 78) and 8.30 ± 0.36 to 4.47 ± 0.86 Log10 IU/mL (TDF, n = 53), with viral load reductions of 3.87 versus 3.83 Log10 IU/mL. The HBsAg-positive rates among 12-month-old infants were 1.28% (1/78) versus 1.82% (1/55) respectively (p = 1.00). Of the TAF or TDF-treated mothers, 25.64% versus 16.98% experienced ALT > 2X ULN, and 11.54% versus 1.89% received extended antiviral treatment. Our model revealed four distinct ALT patterns: stable ALT (87.2%), moderate (8.0%) or marked (2.4%) postpartum flares, or prepartum elevations (2.4%). CONCLUSIONS: TAF effectively reduces mother-to-child HBV transmission, but prophylaxis failure still occurred in few cases. Postpartum ALT flares are common in women receiving TAF or TDF during pregnancy. Approximately 12.8% of mothers may require extended postpartum antiviral treatment. CLINICAL TRIAL NUMBER: NCT03695029 (ClinicalTrials.gov).

An Alternative Treatment for Uterine Fibroids and Adenomyosis: High-intensity Focused Ultrasound.

Uterine fibroids and adenomyosis are benign tumors commonly seen in gynecology clinics, more than cancers of the cervix or uterine cancers. Surgical methods for adenomyosis are often unsatisfactory, difficult, and not reproducible. Ultrasound (US)-guided high-intensity focused ultrasound (HIFU) (US-guided HIFU) adds another dimension to surgery for the treatment of fibroids and adenomyosis. It offers patients an alternative choice to be treated. US-guided HIFU revolutionizes the art of surgery and is a new disruption in the world of medicine.

Origami Box Folding Exercise: A laparoscopic box simulation training and assessment method in facilitating laparoscopic psychomotor skills with minimal preparation.

OBJECTIVE: Laparoscopic box simulation training is widely recognized as an assessment tool to facilitate psychomotor skills especially for novice surgeons. However, current commercialized training modules including pegs, gauze, clips, pins etc. are generally costly and relatively inaccessible. We introduce a simple and pioneer surgical training drill, the Origami Box Folding Exercise (OBFE), based on the validated evaluating system of objective structured assessment of technical skills (OSATS) constructed with the scoring system of procedure-specific checklist (PSC) and global rating scale (GRS). MATERIALS AND METHODS: Face and content validation of the OBFE and OSATS are evaluated by five endoscopic experts from two medical centers in Taiwan. This is a prospective observational study analyzing the pre-test/post-test result of OBFE from 37 participants in two individual workshops as training and evaluating method for laparoscopic psychomotor skills. Both the pre and post tests are video recorded with a time limit of 5 min graded by two independent evaluators based on the OSATS scoring system. RESULTS: The reliability of PSC, GRS, and intergroup value between PSC and GRS were 0.923, 0.926 and 0.933, respectively. Inter-rater reliability of PSC, GRS, and both were 0.985, 0.932 and 0.977, respectively. Construct validity of PSC and GRS were statistically significant, with p-value 0.006 and 0.001, respectively. CONCLUSION: OBFE enhances laparoscopic psychomotor skills with requirement of a single piece of paper. The associated OSATS tool for a 5-min OBFE test was validated. OBFE training is an efficient training and assessment system to promote psychomotor skills in laparoscopic box simulation drill which requires simple and economical preparation.

Vaginal natural orifice transvaginal endoscopic surgery (vNOTES) surgical staging for endometrial carcinoma: The feasibility of an innovative approach.

OBJECTIVE: This study aims to describe the feasibility of treating early-stage endometrial cancer with hysterectomy, bilateral salpingo-oophorectomy, sentinel lymph node biopsy, and bilateral pelvic lymphadenectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES). MATERIALS AND METHODS: A longitudinal study of prospectively registered patients was conducted at an academic tertiary care center. 15 patients who underwent vNOTES surgical staging of early endometrial carcinoma between January 2014 and December 2020 were included in the study. RESULTS: 15 patients between 20 and 80yrs of age with histologically proven Stage1 Gr1-2 endometrial cancer underwent vNOTES surgical staging. The mean age of the study population was 52.8 years (Standard Deviation [SD] 6.8) and the mean BMI was 27.8 kg/m2 (SD 6.4). The average operative time was 231.4 min (SD 41.0) with the mean estimated blood loss of 122.0 mL (SD 104.4). A total of 12 (80%) patients underwent SNL biopsy with ICG guided system, whereas 3 (20%) had pelvic lymph node dissection. There was one case with the surgical complication of bladder injury requiring conversion to conventional laparoscopy. CONCLUSION: With this study, we studied the feasibility of vNOTES surgery for early-stage endometrial cancer with minimal complications and the best long-term surgical outcome. The surgeries were performed by a single skilled endoscopist surgeon with previous experience with vNOTES surgery for adnexal tumors and hysterectomy. Our results showed the practicality of vNOTES in staging surgery for early-stage endometrial cancer. However, application to a larger cohort is required for more extensive surgical outcome studies.

A Proposed High-intensity Focused Ultrasound Training Program in Hong Kong.

High-intensity focused ultrasound (HIFU) surgery is a noninvasive thermal ablation treatment modality, and its clinical application is increasingly introduced into gynecological practices in China and Asia. To further strengthen the technology's standardized management, the Asia-Pacific Association for Gynecologic Endoscopy and Minimally Invasive Therapy (APAGE) collected the consensus of well-known experts in the field. They shared opinions on the management standards of the basic requirements for developing this HIFU technology in medical institutions, operators' training requirements, technical management, HIFU training program, etc., Based on the recommendations from APAGE, Hong Kong Focused Ultrasound Surgery Association developed its proposed HIFU training program for gynecologists in Hong Kong. This paper will present the training requirements and hopefully share its training and credentialing rationales with other HIFU medical institutes.

Treating Deep Endometriosis in Infertile Patients before Assisted Reproductive Technology.

Deep endometriosis (DE) causes infertility and pelvic pain. Surgical management of DE has become a topic of increasing interest in gynecological surgery. In women desirous of pregnancy, optimal management such as surgery versus first-line assisted reproductive technology (ART) for patients with severe endometriosis is strongly debated. Current guidelines and literature including retrospective and prospective studies in English available on DE surgery, infertility, and pregnancy outcomes following surgery were searched in Cochrane Library with DE, DIE, Infertility, "DE surgery and pregnancy outcomes," and "Deep infiltrating endometriosis and assisted reproduction" as keywords. The purpose was to find evidence to answer the following clinical questions: How does DE affect fertility and pregnancy? What are the possible benefits of primary surgery for DIE before in vitro fertilization (IVF)? Several studies have recently concluded that surgical removal of DE nodules might actually have a favorable impact on IVF outcomes. This is in contradiction to European Society of Human Reproduction and Embryology statement which stated that there was no evidence supporting surgical management of DE prior to ART to improve pregnancy rate; several studies have suggested that the surgical removal of DE nodules might actually have a favorable impact on IVF outcomes. Treatment of DE affecting the rectovaginal septum or bowel requires complex surgery with considerable risk of complications. This review article tries to analyze the rationale of surgical treatment of DE before ART. A balance must be struck between exposing the patient to surgical risk and improvement in pain and fertility potential. Decisions should be tailored according to the individual needs of each woman and most importantly on the ability of the surgeons.

Laparoscopic "Shaving" for Infiltrative External Adenomyosis of Bowel Muscularis and Concomitant Deep Infiltrating Endometriosis.

Deep infiltrating endometriosis (DIE) is a common finding in patients diagnosed with adenomyosis. Women commonly present with severe, incapacitating dysmenorrhea. We report a case of severe dysmenorrhea and lower abdominal tightness for 4 years, diagnosed with posterior adenomyosis. The patient underwent surgery and DIE involving the rectosigmoid and coexisting uterocervical adenomyosis infiltrating bowel muscularis successfully diagnosed and treated using laparoscopic "shaving" technique. Dysmenorrhea significantly resolved after surgery. Laparoscopic surgical "shaving" technique for external adenomyosis infiltrating Rectosigmoid muscularis is feasible, where uterine preservation is desired.

Immunomodulating Therapy by Picibanil-based Imiquimod and Virotherapy for Advanced Uterine Cancer after Laparoscopic Surgery.

This is a case report of a uterine cancer with the International Federation of Gynecology and Obstetrics staging 3c2 with the initial clinical presentation of postmenopausal vaginal bleeding in August 2015. Endometrium biopsy showed invasive nests of poorly differentiated grade 3 endometrioid adenocarcinoma. The patient received robotic surgery including total hysterectomy, bilateral salpingo-oophorectomy, bilateral pelvic lymph node dissection, para-aortic lymph node dissection, and washing cytology. The final pathology showed an endometrioid carcinoma with myometrium invasion up to 85% and para-aortic and pelvic lymph nodes invasion. The patient received six courses of adjuvant chemotherapy (paclitaxel and carboplatin) with concurrent chemoradiotherapy after the surgery. Later, immunotherapy with Picibanil (OK-432) and interleukin-2 (IL-2) was given, and cancer did not recur for 34 months until tumor recurrence at the liver dome and bilateral lung was noted by positron-emission tomography scan in July 2018. The patient received laparoscopic surgery for intra-abdominal tumor excision in December 2018, and the tumor found extended to the right diaphragm, liver surface, omentum, bilateral flank to pelvic peritoneum, Douglas pouch, and upper rectum. We continued the immunotherapy with OK-432, IL-2, Aldara cream (imiquimod), and later on, virotherapy (human papillomavirus vaccine). The immune risk profiles showed T-cells' proliferation and alteration of the Th1/Th2 activation after immunotherapy and virotherapy. Proctectomy with colon-anal anastomosis and cytoreduction surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) (doxorubicin and paclitaxel) was performed in January 2019. After the surgery, the patient received chemotherapy (topotecan, paclitaxel, lipodox, and carboplatin) and continued the immunotherapy. The immune risk profiles showed CD4, CD4/CD8 increase after HIPEC and immunotherapy. The patient continued the therapy until May 2020.

Standardization and experience may influence the survival of laparoscopic radical hysterectomy for cervical cancer.

OBJECTIVE: Minimally invasive radical hysterectomy has been shown to be associated with poorer outcome in an influential prospective, randomized trial. However, many centers worldwide performing minimally invasive radical hysterectomy have data and experience that prove otherwise. We aim to review surgical and oncologic outcomes of patients operated by Laparoscopic Radical Hysterectomy in a tertiary hospital, by experienced surgeons and standardization in radicality, for cervical carcinoma Stage 1A1-1B1 from January 2009 to May 2014. MATERIALS & METHODS: Standardised surgical technique with Parametrium & Paracolpium resection approach was adopted by qualified and experienced Gynecologic/Gyne-Oncologic Endoscopic & Minimally Invasive Surgeons in performing Laparoscopic Radical Hysterectomy for Cervical Cancer stage 1A1-1B1 from January 2009-May 2014, involving 53 patients. Electronic Medical Record system (EMR) Of Chang Gung Memorial Hospital(Tertiary Referral Centre), Department of Obstetrics & Gynecology was accessed for surgical and oncologic outcomes. RESULTS: Fifty-Three patients operated from January 2009 to May 2014 were followed up for an average of 96.7 months with longest follow-up at 127 months. There were no cases of recurrence or death reported. 5 Year - Survival Rate and 5 Year Disease-Free Survival Rate were 100%. Two patients received post-operative pelvic radiation concurrent with chemotherapy using Cisplatin due to greater than 1/3 cervical stromal invasion. CONCLUSION: It is vital to standardize minimally invasive surgical techniques for early stage cervical cancer, with focus on adequate radicality and resection which may contribute to excellent survival outcomes. Further international multi-center randomized trial (Minimally Invasive Therapy Versus Open Radical Hysterectomy In Cervical Cancer) will provide justification for continued practice of MIS in early stage cervical cancer.

The effect of the electronic platform of menopausal health screen system and counseling intervention on the empowerment of menopausal women: a quasi-experimental study.

This article explores the efficacy of the electronic platform of menopausal health screen system (EPMHSS) and counseling intervention on the empowerment of menopausal women, seventy four participants were randomly assigned to this study. The intervention group significantly relieved menopausal disturbance, reduced uncertainty, increased health behaviors, and decreased waist circumference after the fourth and eighth week compared with the control group. Our results proved that EPMHSS and counseling would help menopausal women to become more aware of their health, as a result, effectively empowered themselves to take actions for improving their health.

Interval Laparoscopic Transabdominal Cervical Cerclage (ILTACC) Using Needleless Mersilene Tape for Cervical Incompetence.

Interval Laparoscopic Transabdominal Cervical Cerclage (ILTACC) has become a procedure of choice for many laparoscopic surgeons in nonpregnant patients diagnosed with cervical incompetence (CI) due to the inherent advantages it offers. The study was conducted to describe the feasibility of performing a three-step approach of ILTACC using a needleless mersilene tape in patients diagnosed with CI. A case series of three patients diagnosed with CI who underwent ILTACC using needleless mersilene tape referred at a tertiary hospital for cerclage. Women diagnosed with CI who underwent ILTACC using a needleless mersilene tape were included in the study, and surgical outcomes were measured. Descriptive statistics were used to describe the demographic profile and surgical outcomes of the patients. Three patients with a mean age of 31 (standard deviation [SD] = 4.96) years with a gravidity of 2.67 (SD, 0.82) and parity of 0.33 (SD, 0.47) were selected. The cervical length was 1.98 (SD, 0.76) cm. The average operative time was 149 (SD, 43.87) minutes. All patients had minimal blood loss (≤ 60 ml) without intraoperative blood transfusion. The hospital stay was 1.33 (SD, 0.47) days with a median of 1 and a range of 1-2 days. No intraoperative or postoperative complications were noted. No cases were converted to laparotomy. The result of this article shows the safety and feasibility of ILTACC using needleless mersilene tape. However, it should be evaluated in more cases.

Transvaginal Natural Orifice Transluminal Endoscopic Surgery Myomectomy Followed by Hysterectomy.

Transvaginal surgery is the most minimally invasive surgery for a gynecologic procedure. A 67-year-old woman who had four children with vaginal deliveries and one abortion, with no underlying disease and a body mass index of 22.4 kg/m2, came to the hospital due to menorrhagia. Her diagnosis was myoma uteri from an asymptomatic palpated mass at the lower abdomen. The ultrasonography showed a 9 cm × 5.9 cm myoma mass at the anterior wall of the uterus. After counseling, the transvaginal natural orifice transluminal endoscopic surgery (NOTES) operation was conducted on May 2018. The process was a transvaginal NOTES hysterectomy following a transvaginal NOTES-assisted myomectomy. The uterine weight was 376 g. In this case, the surgeons could not enter into the pelvic cavity completely because the myoma mass was attached to the bladder which led to the surgeons safely performing the transvaginal NOTES myomectomy before the hysterectomy.

Prevalence of symptoms and associated factors across menopause status in Taiwanese women.

OBJECTIVE: To investigate the prevalence of symptoms and associated factors in Taiwanese women calling a menopause hotline. METHODS: A cross-sectional, descriptive, epidemiological study was performed on 20,882 women aged 40 to 89 years registered in the menopause consultation database of the nationwide toll-free consultation hotline for menopause-related issues from January 2006 to December 2016. The data included demography, sources of menopausal health care, and menopause/midlife symptoms scale. RESULTS: The mean menopausal age was 49.6 ± 4 years. The prevalence of the symptoms increased with the progress of the menopausal stages, and the differences between stages were significant. The top five symptoms reported on a menopause hot line were memory loss (66.9%), fatigue (66.5%), insomnia (59.6%), depressed mood (58.5%), and back pain (58.2%). Of the women, 23.5% did visit a medical facility for menopausal problems mainly the department of gynecology. More than half of the women (56.4%) opted for medical personnel as the preferred channel for obtaining information concerning menopause. Women who had a higher education level, were single, had no children, were not experiencing the empty-nest phenomenon, were employed, had no chronic disease, were premenopausal, had never received hormone therapy, and had not visited medical facilities scored the lowest in menopause/midlife symptoms. CONCLUSIONS: Compared with premenopausal and perimenopausal women, postmenopausal women experience the most severe symptoms. Therefore, establishing a menopause consultation hotline answered by medical personnel and implementing support for postmenopausal women to obtain strategies to alleviate symptoms are required and necessary.

Video Summary:http://links.lww.com/MENO/A651.