An 8-mm trocar-site hernia at a drainage insertion site after a three-port robotic myomectomy: case report and review of literature.

Trocar site hernia is a rare, serious operation-related complication after robotic gynecologic surgery. Here, we present two 8-mm port-site hernia cases after three-port robotic myomectomy with a review of reported previous cases. In the first case, small bowel obstruction was found postoperatively due to herniation at the left mid-axillary line 8-mm trocar site. Small bowel herniation through the same site as the first case was found in the second case. Emergency exploration was performed in both cases by extending the left trocar site. There was no sign of bowel ischemia, and successful bowel reduction and hernia repair were done. Unlike previously reported cases, these cases occurred in a normal body mass index (BMI) patient (first case 20.28 kg/m2, second case BMI 24.80 kg/m2) and were pelvic drain insertion sites. These sites were the weak points of the abdominal muscle coverage. Therefore, the closure of 8-mm trocar sites should be considered.

Surgical and Fertility Outcomes of Reduced-Port Robotic Myomectomy: A Single-Center Experience of 401 Cases.

Background: Reduced-port robotic myomectomy (RPRM) using Da Vinci® Xi™ is a good fertility-saving surgical option, but the surgical and fertility outcomes are unknown. Methods: This was a retrospective cohort study evaluating the feasibility of RPRM in an academic tertiary hospital setting. A total of 401 patients who underwent RPRM by a single operator between October 2017 and October 2021 were included. For RPRM, three ports are required: a 1.5 cm umbilical incision and two 0.8 cm incisions 8 cm lateral to the umbilicus. A single-port system was applied through the umbilicus, which also functioned as a working port. Unlike conventional robotic surgery, only three robot arms were utilized for the entire surgical procedure. Results: Surgical and fertility outcomes were assessed through medical records review and follow-up telephone contact. The mean age of patients at the time of surgery was 39.7 ± 6.0 years. The most common indication for surgery was menorrhagia (n = 128, 31.9%). The average number of myomas removed was 4.7 ± 4.1 (1-22), and the size was 7.8 ± 2.5 cm (2.5-16.0). The mean operation time was 103.7 ± 45.6 min. Postoperative complications were found in 9.7% (n = 39) of patients; the most common complication was transfusion (7.7%, n = 31). After surgery, 70 patients tried to conceive, and 56 became pregnant naturally or by assisted reproduction (56/70, 80.0%). The mean interval time from operation to conception was 13.5 ± 10.1 months. Among 56 who conceived, 44 gave birth (62.9%), five were still ongoing (7.1%), and seven had miscarriages (10.0%). Cesarean section was performed for most cases (43/44, 97.7%). Eight patients had obstetric complications (16.3%), but no uterine rupture was reported. Conclusions: RPRM, which provides the benefits of conventional robotic surgery along with favorable obstetric and cosmetic results, is a feasible option for patients with symptomatic uterine myomas who wish to conceive in the future.

Comparison of ovarian reserve after cystectomy of ovarian endometrioma by bipolar coagulation, suture method, or hemostatic sealants: An updated meta-analysis.

AIM: The purpose of the study was to compare the ovarian reserve after cystectomy of ovarian endometrioma by bipolar coagulation, suture method, or hemostatic sealants (HSs). METHODS: We performed a meta-analysis of studies in which post-cystectomy serum anti-Müllerian hormone (AMH) values were compared between bipolar coagulation and suture method or between bipolar coagulation and HSs. Through a literature search, we retrieved 14 articles which met inclusion criteria and were eligible for final analysis. The articles included 10 randomized trials, 3 prospective studies, and 1 retrospective study (n = 1435). The primary outcome was post-cystectomy serum AMH values. RESULTS: Both bipolar coagulation and suture methods showed significantly lower post-cystectomy AMH values at 3, 6, and 12 months. However, post-cystectomy serum AMH values at 12 months were significantly higher in the suture method group compared to the bipolar coagulation (weighted mean difference [WMD]: -1.10, 95% confidence interval [CI]: -1.83, -0.38, p = 0.003, I2 = 89, n = 3). The suture method also showed a lower decline rate at 3 months post-cystectomy compared to the bipolar coagulation group (WMD: -25.13%, 95% CI: -49.56 to -0.70, p = 0.04, I2 = 95%, n = 2). Overall, pregnancy rates were similar between the two groups. Between the bipolar coagulation and HSs group, serum AMH values at 3 months post-cystectomy were similar (WMD: -0.46, 95% CI: -1.04 to 0.13, p = 0.13, I2 = 0%, n = 3). However, the HSs group showed a less decline rate at 3 months post-cystectomy compared to the bipolar coagulation group (WMD: -17.02%, 95% CI: -22.81, -11.23, p < 0.00001, I2 = 0%, n = 3). CONCLUSIONS: Both the suture method and HSs may have potential benefits in the preservation of ovarian reserve over the bipolar coagulation method when cystectomy for ovarian endometrioma is performed.

Impact of Ablation Versus Cystectomy for Endometrioma on Ovarian Reserve, Recurrence, and Pregnancy: An Updated Meta-Analysis.

This study aimed to compare the impact of ablation and cystectomy for ovarian endometrioma on ovarian reserve, recurrence rates, and pregnancy rates. Databases were searched for studies reporting ovarian reserve (measurement of anti-müllerian hormone [AMH] only), recurrence rates, and/or pregnancy rates after cystectomy and ablation for ovarian endometrioma. Six randomized clinical trials and five prospective cohort studies were included in this meta-analysis. All included studies had a low risk of bias. After ablation, weighted mean difference (WMD) between post- and pre-operative AMH values was - 0.40 (95% confidence interval [CI]: -0.61 to -0.19, p = 0.0002, I2 = 0%). After cystectomy, the WMD of AMH was - 1.08 (95% CI: -1.34 to -0.82, p < 0.00001, I2 = 48%). The intergroup comparison revealed that pre-operative AMH values were similar between the two groups, but post-operative AMH was significantly higher in the ablation group (WMD: 0.38, 95% CI: 0.13 to 0.63, p = 0.003, I2 = 3%). Subgroup analysis showed that the favorable effects of ablation compared to cystectomy are evident after three months of operation, in a bilateral setting, or with the laser ablation method. Overall recurrence rate (risk ratio [RR]: 1.51, 95% CI: 1.08 to 2.12, p = 0.02, I2 = 0%) and one-year recurrence rate (RR: 2.36, 95% CI: 1.30 to 4.31, p = 0.005, I2 = 0%) were significantly higher in the ablation group than in the cystectomy group. Pregnancy rates were similar between the two groups (odds ratio: 1.18, 95% CI: 0.92 to 1.52, p = 0.20, I2 = 72%). These results demonstrate that ablation could result in a smaller serum AMH decrement than cystectomy, but the recurrence rate could be higher after ablation.

A Successful Live Birth From a Vitrified Oocyte for Fertility Preservation of a Patient With Borderline Ovarian Tumor Undergoing Bilateral Ovarian Surgery: A Case Report.

This article reports the live birth of a healthy newborn using vitrified-warmed oocytes from fertility preservation before ovarian surgery. The patient in our case underwent two cycles of controlled ovarian stimulation before laparoscopic bilateral ovarian cystectomy for endometriosis, and a total of 23 mature oocytes were vitrified. After surgery, her pathologic reports revealed a serous borderline tumor and endometrioma. Fifteen months after her second surgery of laparoscopic right salpingo-oophorectomy and left ovarian cystectomy owing to recurrence, she had been married by then, and three of the frozen oocytes were thawed for intracytoplasmic sperm injection. These oocytes were cryopreserved for 2.5 years. All three were fertilized, and two grade-A cleavage-stage embryos were transferred. A singleton pregnancy was achieved, resulting in the delivery of a healthy baby boy at 39.3 weeks of gestation. Oocyte cryopreservation is an effective method for fertility preservation prior to ovarian surgery when ovarian function decline is predictable.

Factors affecting the ongoing pregnancy rate in women with repeated implantation failure undergoing an endometrial receptivity array.

OBJECTIVE: In this retrospective study, we analyzed factors influencing the ongoing pregnancy rate (PR) in women with repeated implantation failure (RIF) undergoing embryo transfer with endometrial receptivity array (ERA). METHODS: Eighty-three consecutive personalized embryo transfers (pETs) with ERA, from 54 women with RIF, were selected from June 2020 to April 2022. Vitrified blastocyst transfer was timed based on ERA results. RESULTS: The ongoing PR per pET was 33.7%. Using ERA, the endometrium was identified as pre-receptive in 26 cycles, early receptive in 25 cycles, receptive in 31 cycles, and late receptive in one cycle. With cycles categorized into three receptivity phases (pre-receptive, early receptive, or receptive), no significant differences were found in the clinical PR (27.3%, 55.6%, and 40%, respectively) or ongoing PR (9.1%, 55.6%, and 40%, respectively) after a single blastocyst transfer. Similarly, no significant differences were observed in the clinical PR or ongoing PR after the transfer of two or more blastocysts. Among women with ongoing pregnancy relative to those without, age at first pET was significantly lower (35 years vs. 39 years, p=0.001), while blastocyst score (23 vs. 18, p=0.012) and the proportion of blastocyst scores >18 (71.4% vs. 38.9%, p=0.005) were significantly higher. In multiple logistic regression analysis, the woman's age (odds ratio [OR], 0.814; 95% confidence interval [CI], 0.706 to 0.940; p=0.005) and blastocyst score >18 (OR, 3.052; 95% CI, 1.075 to 8.665; p=0.036) were identified as significant factors influencing ongoing pregnancy. CONCLUSION: In pET with ERA, ongoing pregnancy was closely associated with woman's age and blastocyst quality.

Cumulative pregnancy rate via multiple fresh or frozen embryo transfers in women with current, resected, or recurred endometrioma.

OBJECTIVE: This study aimed to retrospectively analyze the cumulative pregnancy rate (PR) via multiple fresh or frozen embryo transfers (ET) in women with current, resected, or recurred endometrioma. MATERIALS AND METHODS: The IVF data including oocyte pick-up (OPU) and fresh or frozen ET in women with current (37 women; 56 OPU, 18 fresh and 14 frozen ET), resected (24 women; 50 OPU, 17 fresh and 42 frozen ET), or recurred endometrioma (28 women; 49 OPU, 22 fresh and 24 frozen ET) were obtained. All cycles were performed from 2015 to 2022 in a single university hospital. RESULTS: The median serum AMH level (ng/mL) was 1.44, 1.47, and 0.98, respectively. The number of total or mature oocytes, fertilized oocytes, cleavage embryos at day-3, and top-quality embryos at day-3 were all similar in the three groups. Cycles with no oocyte occurred in 2 (3.6%), 1 (2%), and 3 cycles (6.1%), respectively. Freeze-all was performed in 46.3%, 59.2%, and 47.8% of the cycles, respectively (p > 0.05). The cumulative clinical PR per total ET (43.8%, 25.4%, and 21.7%), per OPU (25%, 30%, and 20.4%), and per woman (37.8%, 62.5%, and 35.7%) were all similar in the three groups. The cumulative ongoing pregnancy and live birth rate per total ET, per OPU, and per woman were also similar in the three groups. CONCLUSION: Similarity in ovarian reserve, number of oocytes, number of embryos, cumulative clinical PR, and live birth in the three endometriosis groups indicates that the IVF outcomes in the 'recurrent endometrioma' group are not inferior to 'current' or 'resected' group.

Impact of thyroid autoantibodies and serum TSH level on clinical IVF outcomes.

OBJECTIVE: This study aimed to investigate the impact of thyroid autoantibodies and serum TSH levels on clinical IVF outcomes. MATERIALS AND METHODS: This study included 260 Korean women scheduled for their first IVF between 2013 and 2017. Serum levels of thyroid hormone, TSH, and antibody for thyroid peroxidase and thyroglobulin were measured just before the first ovarian stimulation. Clinical pregnancy rate (PR), ongoing PR, and miscarriage rate were analyzed according to thyroid autoimmunity and serum TSH levels. The primary outcome was ongoing PR beyond 12 weeks of gestation. RESULTS: The ongoing PR and miscarriage rates were similar between women with positive (n = 29) and negative autoantibodies (n = 186). In women with subclinical hypothyroidism (serum TSH ≥4.2 µIU/mL), ongoing PR was significantly lower than euthyroid women (22.2%, vs. 44.7%, p = 0.045), but miscarriage rate was similar. The group with serum TSH ≥3.4 µIU/mL showed a significantly lower ongoing PR (23.9% vs. 46.7%, p = 0.005) and significantly higher miscarriage rate (38.9% vs. 14.1%, p = 0.020). In multivariate logistic regression analysis, serum TSH ≥3.4 µIU/mL was an independent unfavorable predictor for ongoing PR (odds ratio 0.375, p = 0.013). CONCLUSION: Thyroid autoantibodies did not affect clinical IVF outcomes, but women with serum TSH ≥3.4 µIU/mL demonstrated poor IVF outcomes.

Fertility Preservation in Young Women With Breast Cancer: A Review.

Fertility preservation is a major concern in young patients diagnosed with breast cancer and planning to receive multimodality treatment, including gonadotoxic chemotherapy with or without age-related decline through long-term endocrine therapy. Most breast cancer patients undergo multimodality treatments; many short-term and long-term side effects arise during these therapies. One of the most detrimental side effects is reduced fertility due to gonadotoxic treatments with resultant psychosocial stress. Cryopreservation of oocytes, embryos, and ovarian tissue are currently available fertility preservation methods for these patients. As an adjunct to these methods, in vitro maturation or gonadotropin-releasing hormone agonist could also be considered. It is also essential to communicate well with patients in the decision-making process on fertility preservation. It is essential to refer patients diagnosed with breast cancer on time to fertility specialists for individualized treatment, which may lead to desirable outcomes. To do so, a multimodal team-based approach and in-depth discussion on the treatment of breast cancer and fertility preservation is crucial. This review aims to summarize infertility risk related to currently available breast cancer treatment, options for fertility preservation and its details, barriers to oncofertility counseling, and psychosocial issues.

Female reproduction and abnormal uterine bleeding after COVID-19 vaccination.

Coronavirus disease 2019 (COVID-19) vaccines have been widely administered throughout the global community to minimize the morbidity and mortality caused by the COVID-19 pandemic. Although generally well-tolerated, these vaccines have generated some unwanted consequences, including thrombosis and menstrual irregularities. The effect of vaccination on female reproductive function has also been questioned. The aim of this review is to give readers a clear understanding of the effects of COVID-19 vaccines on thrombosis, reproductive function, and menstrual irregularities by systemically analyzing the available literature. The available evidence suggests that COVID-19 vaccines have a minimal impact on ovarian reserve. Furthermore, in vitro fertilization outcomes after COVID-19 vaccination remain unimpaired compared to those who did not receive the vaccines. Current evidence supports a certain degree of impact of COVID-19 vaccines on the menstrual cycle, with the most frequent alteration being menstrual irregularity, followed by menorrhagia. These changes are generally well-tolerated and transient, lasting less than 2 months. This review, by providing information with up-to-date references on this issue, may enhance readers' understanding of the impact of COVID-19 vaccines on female reproductive function and the menstrual cycle.

Sperm DNA fragmentation in consecutive ejaculates from patients with cancer for sperm cryopreservation.

OBJECTIVE: This prospective consecutive study investigated the variation in sperm DNA fragmentation (SDF) in multiple semen samples from patients with cancer. METHODS: Eighty-one patients with various cancers underwent multiple semen collections on 3 consecutive days for sperm cryopreservation prior to cancer treatment. A commercial Halosperm kit was used to measure SDF. Within- and between-subject coefficients of variation were estimated via random-effects analysis of variance to assess the consistency of semen parameters and SDF. Intraclass correlation coefficients (ICCs) were calculated to assess the magnitude of the between-subject component of variance relative to the total variance. RESULTS: The volume of semen in the day-2 and day-3 samples was significantly lower compared with the day-1 sample. Most parameters showed high ICC values, suggesting that within-subject fluctuations were small relative to the between-subject variability. The highest ICC values were identified for the SDF (ICC, 0.68; 95% confidence interval [CI], 0.45-0.84) and semen volume (ICC, 0.67; 95% CI, 0.45-0.84). CONCLUSION: Our findings showed that repeated ejaculates from patients with cancer had stable SDF levels.

The Clinical Desire for Pressurized Intraperitoneal Aerosol Chemotherapy in South Korea: An Electronic Survey-based Study.

BACKGROUND/AIM: To evaluate the clinical desire for pressurized intraperitoneal aerosol chemotherapy (PIPAC) in South Korea. PATIENTS AND METHODS: We performed an online survey on surgical oncologists between November and December 2019 using a questionnaire consisting of 20 questions. RESULTS: A total of 164 respondents answered the questionnaire. Among those specialized in ovarian cancer, pseudomyxoma peritonei, and malignant mesothelioma 41.7-50% preferred PIPAC for the curative treatment of primary diseases, whereas 32.7-33.3% majoring in colorectal and hepatobiliary cancers chose it for the palliative treatment of recurrent diseases. Furthermore, 66.7-95.2% considered PIPAC appropriate for the cancers they specialized in, and 76-78.7% expected a treatment response of more than 50% and considered grade 1 or 2 complications acceptable. Most respondents answered the reasonable costs to purchase and implement PIPAC once at between 1,000,000-5,000,000 South Korean Won (KRW). CONCLUSION: Most Korean surgical oncologists expected relatively high tumor response rates with minor toxicities through the repeated implementation of PIPAC.

Prognostic role of computed tomography-based, artificial intelligence-driven waist skeletal muscle volume in uterine endometrial carcinoma.

OBJECTIVES: To investigate the impact of computed tomography (CT)-based, artificial intelligence-driven waist skeletal muscle volume on survival outcomes in patients with endometrial cancer. METHODS: We retrospectively identified endometrial cancer patients who received primary surgical treatment between 2014 and 2018 and whose pre-treatment CT scans were available (n = 385). Using an artificial intelligence-based tool, the skeletal muscle area (cm2) at the third lumbar vertebra (L3) and the skeletal muscle volume (cm3) at the waist level were measured. These values were converted to the L3 skeletal muscle index (SMI) and volumetric SMI by normalisation with body height. The relationships between L3, volumetric SMIs, and survival outcomes were evaluated. RESULTS: Setting 39.0 cm2/m2 of L3 SMI as cut-off value for sarcopenia, sarcopenia (< 39.0 cm2/m2, n = 177) and non-sarcopenia (≥ 39.0 cm2/m2, n = 208) groups showed similar progression-free survival (PFS; p = 0.335) and overall survival (OS; p = 0.241). Using the median value, the low-volumetric SMI group (< 206.0 cm3/m3, n = 192) showed significantly worse PFS (3-year survival rate, 77.3% vs. 88.8%; p = 0.004) and OS (3-year survival rate, 92.8% vs. 99.4%; p = 0.003) than the high-volumetric SMI group (≥ 206.0 cm3/m3, n = 193). In multivariate analyses adjusted for baseline body mass index and other factors, low-volumetric SMI was identified as an independent poor prognostic factor for PFS (adjusted HR, 1.762; 95% CI, 1.051-2.953; p = 0.032) and OS (adjusted HR, 5.964; 95% CI, 1.296-27.448; p = 0.022). CONCLUSIONS: Waist skeletal muscle volume might be a novel prognostic biomarker in patients with endometrial cancer. Assessing body composition before treatment can provide important prognostic information for such patients.

SERPINB11 Expression Is Associated With Prognosis of High-grade Serous and Clear Cell Carcinoma of the Ovary.

BACKGROUND/AIM: To evaluate the role of serine protease inhibitor B11 (SERPINB11) expression as a prognostic biomarker in high-grade serous carcinoma (HGSC) and clear cell carcinoma of the ovary (CCC). MATERIALS AND METHODS: We obtained tumor tissues from patients with HGSC (n=145) and CCC (n=59). We evaluated immunohistochemically the expression of SERPINB11 and investigated whether SERPINB11 expression affects platinum-resistance and the prognosis of HGSC and CCC. RESULTS: High expression of SERPINB11 was more common in CCC than in HGSC (57.6% vs. 28.3%; p<0.01), and SEPRINB11 expression did not correlate with platinum-resistance of HGSC and CCC. High expression of SERPINB11 was associated with worse progression-free survival and overall survival with marginal significance in HGSC; no relation between SERPINB11 expression and the prognosis of CCC was found. CONCLUSION: SERPINB11 expression maybe a prognostic biomarker for HGSC.

Preservation of the ovarian reserve and hemostasis during laparoscopic ovarian cystectomy by a hemostatic agent versus suturing for patients with ovarian endometriosis: study protocol for randomized controlled, non-inferiority trial (PRAHA-2 trial).

BACKGROUND: Endometriosis (EMS) can be implanted everywhere, especially in pelvic organs. EMS can be asymptomatic, but it can result in pelvic pain and infertility by inducing local inflammation and pelvic adhesion. The prevalence of EMS is about 10% in reproductive-age women and higher in women with pelvic pain or infertility. For young patients with ovarian EMS, laparoscopic ovarian cystectomy is effective in relieving pelvic pain and preventing local recurrence. However, there is a concern that the ovarian reserve would decrease after the operation because of the removal of a part of the normal ovarian tissue and thermal damage during hemostasis, which depends on the types of hemostasis such as bipolar electrocoagulation, suturing, and the use of a hemostatic agent. In this study, we aim to evaluate the protective effect for the ovarian reserve and hemostasis between a hemostatic agent and suturing during laparoscopic ovarian cystectomy for patients with ovarian EMS. METHODS: This study is a randomized controlled, non-inferiority trial, where a total of 90 patients with ovarian EMS will be randomly assigned to the experimental (hemostatic agent) and control (suturing) groups. In the control group, a barbed suture will be applied for hemostasis, whereas a hemostatic agent will be applied in the experimental group. If two methods are insufficient, bipolar electrocoagulation will be applied for complete hemostasis. As the primary endpoint, the reduction rate of serum anti- Müllerian hormone (AMH) levels reflecting the ovarian reserve will be compared between the two groups 12 weeks after surgery. As secondary endpoints, we will compare the reduction rate of AMH level 48 weeks after surgery, the time required to complete hemostasis, the success rate of hemostasis within 10 min, and adverse events associated with operation. DISCUSSION: We expect that the protective effect for the ovarian reserve and hemostasis may be comparable between the two methods, suggesting that a hemostatic agent may be preferred considering that it is easy to use during laparoscopic ovarian cystectomy. TRIAL REGISTRATION: ClinicalTrials.gov NCT04643106 . Registered on 22 November 2020.

Development of rotational intraperitoneal pressurized aerosol chemotherapy to enhance drug delivery into the peritoneum.

This study aims to evaluate the drug distribution, tissue concentrations, penetration depth, pharmacokinetic properties, and toxicities after rotational intraperitoneal pressurized aerosol chemotherapy (RIPAC) in pigs. Because relevant medical devices have not been introduced, we developed our prototype of pressurized intraperitoneal aerosol chemotherapy (PIPAC) and RIPAC by adding a conical pendulum motion device for rotating the nozzle. RIPAC and PIPAC were conducted using 150 ml of 1% methylene blue to evaluate the drug distribution and 3.5 mg of doxorubicin in 50 ml of 0.9% NaCl to evaluate the tissue concentrations and penetration depth, pharmacokinetic properties, and toxicities. All agents were sprayed as aerosols via the nozzle, DreamPen® (Dalim Biotech, Gangwon, South Korea), with a velocity of 5 km/h at a flow rate of 30 ml/min under a pressure of 7 bars, and capnoperitoneum of 12 mmHg was maintained for 30 min. As a result, RIPAC showed a wider distribution and stronger intensity than PIPAC. Compared with PIPAC, RIPAC demonstrated high values of the tissue concentration in the central, right upper, epigastrium, left upper, left lower, right lower, and right flank regions (median, 375.5-2124.9 vs. 161.7-1240 ng/ml; p ≤ .05), and higher values of the depth of concentrated diffusion and depth of maximal diffusion (median, 232.5-392.7 vs. 116.9-240.1 µm; 291.2-551.2 vs. 250.5-362.4 µm; p ≤ .05) in all regions except for bowels. In RIPAC, the pharmacokinetic properties reflected hemodynamic changes during capnoperitoneum, and there were no related toxicities. Conclusively, RIPAC may have the potential to enhance drug delivery into the peritoneum compared to PIPAC.

Efficacy and safety of intravenous administration of high-dose selenium for preventing chemotherapy-induced peripheral neuropathy in platinum-sensitive recurrent ovarian, fallopian or primary peritoneal cancer: study protocol for a phase III, double-blind, randomized study.

BACKGROUND: The second-line chemotherapy using paclitaxel, carboplatin, and bevacizumab for treating platinum-sensitive recurrent ovarian, fallopian or primary peritoneal cancer frequently cause chemotherapy-induced peripheral neuropathy (CIPN), which is significantly associated with deterioration of quality of life. Despite the potential of some agents to prevent and treat CIPN, and there is still a lack of evidence of the effect. Although selenium has been suggested as an antioxidant candidate to prevent CIPN, there are insufficient data regarding its effect due to its low dose by oral administration. Thus, we hypothesized intravenous administration of high-dose selenium (2,000 µg/day) at each cycle of the second-line chemotherapy would prevent and reduce CIPN in patients with platinum-sensitive recurrent ovarian, fallopian or primary peritoneal cancer. METHOD: This trial is an investigator-initiated, phase III, double-blinded, randomized controlled trial to evaluate the efficacy and safety of intravenous administration of high-dose selenium (2,000 µg/day) for preventing CIPN in patients with platinum-sensitive recurrent ovarian, fallopian or primary peritoneal cancer who receive paclitaxel, carboplatin, and bevacizumab. A total of 68 patients will be randomly assigned to the experimental and control groups at a 1:1 ratio. As the primary endpoint, the incidence rate of CIPN three months after six cycles of chemotherapy will be compared between the two groups according to the combined criteria of neuropathy using the World Health Organization-CIPN criteria and Common Terminology Criteria for Adverse Events version 5.0. As secondary endpoints, we will compare adverse events, patient-reported quality of life, and requirement of concomitant drugs for reducing CIPN between the two groups. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04201561.

Pressurized intraperitoneal aerosol chemotherapy for recurrent ovarian, fallopian or primary peritoneal cancer with peritoneal carcinomatosis: a narrative review.

For recurrent ovarian, fallopian or primary peritoneal cancer with peritoneal carcinomatosis (PC), it is challenging to resect tumors completely or to get complete remission by intravenous (IV) chemotherapy, and many patients show the resistance to various chemotherapeutic agents for IV chemotherapy ultimately. As an alternative, pressurized intraperitoneal aerosol chemotherapy (PIPAC) has been introduced for treating the disease, which delivers chemotherapeutic agents as an aerosol form while maintaining high intraperitoneal (IP) pressure. Based on preclinical studies, PIPAC showed better penetration depth and distribution of drugs into the peritoneum in comparison to conventional IP chemotherapy. Tumor regression on histology and peritoneal carcinomatosis index (PCI) has also been shown in relevant studies. In addition, most of the PIPAC procedures were completed successfully with acceptable toxicity due to the use of a low dose of chemotherapeutic agents. For considering these advantages of PIPAC, we review the current status of PIPAC for treating recurrent ovarian, fallopian or primary peritoneal cancer through literature review.