Safety and efficacy study of laparoscopic or robotic radical surgery using an endoscopic stapler for inhibiting tumour spillage of cervical malignant neoplasms evaluating survival (SOLUTION): a multi-centre, open-label, single-arm, phase II trial protocol.

BACKGROUND: The Laparoscopic Approach to Cervical Cancer trial and Surveillance, Epidemiology, and End Results program database study demonstrated that minimally invasive radical hysterectomy was inferior to abdominal radical hysterectomy in terms of disease recurrence and survival. Among risk factors related to poor prognosis after minimally invasive surgery (MIS), tumour spillage during intracorporeal colpotomy became a significant issue. Thus, we designed this trial to evaluate the efficacy and safety of minimally invasive radical hysterectomy using an endoscopic stapler for early-stage cervical cancer. METHODS: This trial is a prospective, multi-centre, open-label, single-arm, non-inferiority phase II study. The nine organisations will participate in this trial after the approval of the institutional review board. Major eligibility criteria include women aged 20 years or older with cervical cancer stage IB1 squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma according to the revised 2009 FIGO staging system who will undergo type B2 or C hysterectomy by MIS. The primary endpoint is the 4.5-year disease-free survival (DFS) rate between abdominal radical hysterectomy and MIS using an endoscopic stapler. For calculating the sample size, we hypothesised that the 4.5-year DFS rate after MIS using an endoscopic stapler is assumed to be the same after abdominal radical hysterectomy at 90.9%, and the non-inferiority margin was 7.2%. When we consider a three-year accrual and 4.5-year follow-up, at least 13 events must happen, requiring a total of 111 patients assuming a statistical power of 80% and the one-tailed test of 5% significance. A total of 124 patients is needed, considering a drop-out rate of 10%. DISCUSSION: We expect intracorporeal colpotomy using an endoscopic stapler may prevent tumour spillage during MIS for stage IB1 cervical cancer, showing a comparable prognosis with abdominal radical surgery. TRIAL REGISTRATION: ClinicalTrials.gov ; NCT04370496 ; registration date, May 2020.

Is increased chronological age a contraindication to debulking surgery for elderly patients with advanced ovarian cancer?

We collected data of elderly patients aged 65 years and older who underwent debulking surgery for advanced ovarian cancer in order to explore the impact of old age on surgical outcomes and complications. A total of 120 patients were classified as follows: group 1, 65-69 years (n = 58); group 2, 70-74 years (n = 38); group 3, 75-79 years (n = 17); group 4, ≥80 years (n = 7). There were no differences in most of the characteristics, surgical extent and outcomes, and postoperative complications between the four groups, whereas polypharmacy was more common (6 vs. 5-16; p=.02) and operation time was shorter (median, 194 vs. 285-330 min; p=.02) in group 4. Factors related to frailty rather than age, polypharmacy, preoperative albumin level, estimated blood loss and transfusion increased the risk of postoperative complications. Thus, the impact of old age on surgical extent, outcomes and postoperative complications may be minimal in elderly patients with advanced ovarian cancer. Impact StatementWhat is already known on this subject? Optimal debulking surgery is a significant factor in improving the prognosis of ovarian cancer but it is not easy to perform such radical surgery on elderly patients in fear of increasing surgical morbidity and mortality. Some studies suggest that underlying comorbidities may be a stronger contributing factor to increasing such risk rather than old age although there is not enough evidence yet.What do the results of this study add? Through this study, we could see that increased age is not the determining cause of increased morbidity and mortality in elderly patients who undergo optimal debulking surgery in ovarian cancer. There are other aspects describing a patient's health status that can predict prognosis better rather than age.What are the implications of these findings for clinical practice and/or further research? Old age need not be a contraindication when performing optimal debulking surgery in elderly patients with advanced ovarian cancer.

Anti-N-methyl-D-aspartate Receptor Encephalitis: a Rare Complication of Ovarian Teratoma.

Anti-N-methyl-D-aspartate receptor (anti-NMDAR) encephalitis is a potentially life-threatening but reversible autoimmune disorder characterized by psychiatric symptoms, cognitive dysfunction, speech dysfunction, seizures, movement disorder, decreased level of consciousness, and autonomic dysfunction or central hypoventilation. It occurs predominantly in young women and approximately half of them have underlying tumors, mainly ovarian teratoma. A 24-year old woman was admitted because of fever, headache, abnormal movement and decreased mental status. Five cycles of plasmapheresis improved her neurological and mental status. Anti-NMDAR antibodies in her CSF and serum were positive, and computed tomography revealed a 1-cm sized mass suggestive of mature cystic teratoma arising from the right ovary. We promptly performed laparoscopic right ovarian cystectomy. She was discharged after 2 weeks with mild memory deficit. Prompt removal of ovarian teratoma and multidisciplinary care are particularly important for good outcome.

Risk of occult atypical hyperplasia or cancer in women with nonatypical endometrial hyperplasia.

AIM: The aim of this study was to identify subsets of patients diagnosed with nonatypical endometrial hyperplasia (NAEH) by endometrial biopsy who had high risk for occult atypical endometrial hyperplasia (AEH) or endometrial cancer (EC). METHODS: We retrospectively reviewed the medical records of 281 patients who underwent hysterectomy within 6 months after a diagnosis of NAEH. We collected data on age, body mass index, menopausal status, tamoxifen use, previous history of NAEH, details of endometrial biopsy (location, curettage vs. pipelle sampling), NAEH subtype (simple vs. complex), interval between endometrial biopsy and hysterectomy, indication of hysterectomy and the presence of occult AEH or EC in hysterectomy specimen. Associations between variables and occult AEH or EC were analyzed. Risk of occult AEH or EC in subsets were calculated and visualized using a heatmap. RESULTS: Among 281 patients, 34 (12.1%) and 9 (3.2%) had occult AEH and EC in hysterectomy specimens, respectively. Using univariate analysis, we found age, menopausal status and subtype were associated with occult AEH or EC. Using multivariate analysis, older age (odds ratio = 1.09, P < 0.01) and complex subtype (odds ratio = 3.34, P < 0.01) were independent risk factors. Patients at an age ≥ 51 years with complex NAEH had about 50% risk of occult AEH or EC. CONCLUSION: Women at an age ≥ 51 years with complex NAEH had high risk for occult AEH or EC and surgical treatment can be considered for these patients.

Perioperative Outcomes of 3-Arm Versus 4-Arm Robotic Radical Hysterectomy in Patients with Cervical Cancer.

STUDY OBJECTIVE: To investigate and compare surgical outcomes of the 3 versus 4 robotic arm approaches for robotic surgery in patients with cervical cancer. DESIGN: A retrospective analysis of prospectively collected data (Canadian Task Force classification II-2). SETTING: An academic tertiary hospital. PATIENTS: A total of 142 patients with stage 1A1 to IIB cervical carcinoma who underwent robotic surgery were included for analysis. The subjects were divided according to the surgical approach (i.e., the number of robotic arms), and the 2 groups were compared in terms of intraoperative data and postoperative outcomes. INTERVENTIONS: Robotic radical hysterectomy (RRH) with lymphadenectomy using 3 robotic arms (n = 101) versus 4 robotic arms (n = 41). MEASUREMENTS AND MAIN RESULTS: Perioperative surgical outcomes. The 3-arm robotic approach consisted of a camera arm, 2 robotic arms, and 1 conventional assistant port. An additional robotic arm was placed on the right side of the patient's abdomen for the 4-arm robotic approach. The mean age, body mass index, cell type, Fédération Internationale de Gynécologie et d'Obstétrique stage, and type of surgery were not significantly different between the 2 cohorts. The 3-arm approach showed favorable outcomes over the 4-arm approach in terms of postoperative pain at 6 and 24 hours (3.8 ± 1.8 vs 4.5 ± 1.7 and 2.8 ± 1.7 vs 3.4 ± 1.6, respectively; p = .033 and .049) and postoperative hemoglobin difference (1.8 ± 0.9 vs 2.6 ± 1.3 and 1.9 ± 1.1 vs 2.4 ± 0.9 on days 1 and 3, respectively; p = .002 and .004). The median length of postoperative hospital stay, total operative time, docking time, lymph node yield, and intraoperative and postoperative complication rates were comparable between the 2 cohorts. CONCLUSION: Surgical outcomes and complications rates of RRH for cervical cancer using the 4-arm approach were comparable with that of the 3-arm approach with decreased early postoperative pain in the 3-arm group. Cost-benefit analysis and the impact on surgical training are needed in the future.

Malnutrition Identified by the Nutritional Risk Index and Poor Prognosis in Advanced Epithelial Ovarian Carcinoma.

Ovarian cancer is a chronic disease with a risk of malnutrition. Nutritional Risk Index (NRI) has been reported as a simple and accurate tool to assess the nutritional status. We sought to explore the prevalence of malnutrition and its association with survival in ovarian cancer. A retrospective study was conducted in 213 advanced ovarian cancer patients. NRI was calculated before and at the end of treatment using patients' body weight and serum albumin level. Overall survival (OS) and progression-free survival (PFS) were estimated by Kaplan-Meier method, and associations were assessed using a Cox proportional hazards analysis adjusted for known prognostic variables. Moderate to severely malnourished patients had lower 5-yr OS (45.3%) compared to normal to mild group (64.0%), respectively (P = 0.024). Adjusted for covariates, the relative risk of death was 5.8 times higher in moderate/severely malnourished group identified at the last course of chemotherapy (HR = 5.896, 95% CI = 2.723-12.764, P < 0.001). Similarly, this cohort had shorter PFS compared with normal to mild risk group (median 15 vs. 28 months, P = 0.011). Malnutrition is prevalent among ovarian cancer patients and is found to be a significant predictor for mortality.

Clinical relevance of vaginal natural orifice transluminal endoscopic surgery (vNOTES) in gynecology.

This study reviews the progress and recent advances in vaginal natural orifice transluminal endoscopic surgery (vNOTES) as a minimally invasive gynecologic procedure. The proposed advantages of vaginal natural orifice transluminal surgery include enhanced cosmesis due to a scarless procedure, better exposure compared with the pure vaginal approach, tolerable pain scores, fewer perioperative complications, and a shorter hospital stay. Recent advances in surgical instrumentation and technology have improved the feasibility of vNOTES as an innovative treatment option for gynecological conditions. However, technical challenges and training issues must be overcome before its widespread use. As a promising surgical innovation, further randomized comparative studies are required to clarify the safety and effectiveness of vNOTES in gynecology.

Effect and Safety of Diluted Vasopressin Injection for Bleeding Control During Robot-assisted Laparoscopic Myomectomy in Reproductive Women With Uterine Fibroids: A Randomized Controlled Pilot Trial (VALENTINE Trial).

BACKGROUND/AIM: Vasopressin injected during myomectomy is known to effectively reduce bleeding but is sometimes associated with intraoperative vasoconstriction and hypertension due to systemic absorption. Although there is a growing preference for the use of diluted vasopressin, evidence of its effect and safety is still lacking. PATIENTS AND METHODS: We performed a randomized controlled pilot trial to evaluate the effect and safety of vasopressin diluted in a constant volume during robot-assisted laparoscopic myomectomy (RALM), where a total of 39 women with uterine fibroids were randomly assigned into the following three groups (group 1, 0.2 IU/ml; group 2, 0.1 IU/ml; group 3, 0.05 IU/ml with a total of 100 ml of normal saline). The primary endpoint was to compare estimated blood loss (EBL), and the secondary endpoints were to compare postoperative value and drop ratio of hemoglobin, operation time, transfusion, hospitalization, and complications among the three groups. RESULTS: There were no differences in the number and largest size of uterine fibroids, total weight of uterine fibroids, console time, and volumes of intravenous fluid administered during RALM among the three groups, whereas combined operation was performed more commonly in group 2 than in groups 1 and 3 (53.9% vs. 0 to 7.7%; p=0.01). The primary and secondary endpoints were also not different among the three groups. However, two patients in group 1 (15.4%) showed vasopressin-related hypertension. CONCLUSION: Vasopressin diluted in a volume of 100 ml showed an effective hemostatic effect and safety during RALM (Trial No. NCT04874246 in ClinicalTrial.gov).

Major clinical research advances in gynecologic cancer in 2023: a tumultuous year for endometrial cancer.

In the 2023 series, we summarized the major clinical research advances in gynecologic oncology based on communications at the conference of Asian Society of Gynecologic Oncology Review Course. The review consisted of 1) Endometrial cancer: immune checkpoint inhibitor, antibody drug conjugates (ADCs), selective inhibitor of nuclear export, CDK4/6 inhibitors WEE1 inhibitor, poly (ADP-ribose) polymerase (PARP) inhibitors. 2) Cervical cancer: surgery in low-risk early-stage cervical cancer, therapy for locally advanced stage and advanced, metastatic, or recurrent setting; and 3) Ovarian cancer: immunotherapy, triplet therapies using immune checkpoint inhibitors along with antiangiogenic agents and PARP inhibitors, and ADCs. In 2023, the field of endometrial cancer treatment witnessed a landmark year, marked by several practice-changing outcomes with immune checkpoint inhibitors and the reliable efficacy of PARP inhibitors and ADCs.

Comparison of carboplatin- and cisplatin-based concurrent chemoradiotherapy in locally advanced cervical cancer patients with morbidity risks.

BACKGROUND: The aim of this study was to assess the activity and toxicity of primary carboplatin-based chemoradiotherapy (CarboRT) and to compare CarboRT with cisplatin-based chemoradiotherapy (CisRT) in patients with locally advanced cervical cancer and poor general condition. PATIENTS AND METHODS: Fifty-one locally advanced cervical cancer patients with morbidity risks were prospectively enrolled between January 2007 and April 2010. Eligible patients received weekly intravenous CarboRT with carboplatin 100 mg/m2, and a comparison was made with a historical patient group that received weekly CisRT with cisplatin 40 mg/m2. RESULTS: Median follow-up was 36 months (range: 4-66 months) in the CarboRT group and 53 months (range: 4-121 months) in the CisRT group. Compared with the historical CisRT group, the CarboRT group showed no statistically significant differences in recurrence (hazard ratio [HR], 1.21; 95% confidence interval [CI], 0.52-2.81) and survival (HR, 1.80; 95% CI, 0.49-6.54). The mean numbers of received cycles of CarboRT and CisRT were 7.5 ± 1.4 and 6.0 ± 1.8, respectively (p < .001). The rates of grade 3-4 toxicity were similar in the two groups. CONCLUSIONS: CarboRT was better tolerated than CisRT without compromising tumor response and survival in patients with locally advanced cervical cancer and poor general condition.

Staging laparoscopy for the management of early-stage ovarian cancer: a metaanalysis.

OBJECTIVE: We sought to perform a quantitative analysis on operative outcomes of laparoscopic staging surgery in patients with presumed early-stage ovarian cancer using a metaanalysis. STUDY DESIGN: Electronic searches for studies of laparoscopic staging surgery in patients with ovarian cancer were performed within 3 electronic databases (Medline, Embase, and the Cochrane Library) using the key words "ovarian cancer," "early stage," "laparoscopy," "staging surgery," "staging laparoscopy," and "recurrence." Two authors independently screened articles, and those meeting the defined inclusion/exclusion criteria were included in the metaanalysis. RESULTS: We identified 11 observational studies. The combined results of 3 retrospective studies showed that the estimated blood loss in laparoscopy was significantly lower than that for laparotomy (P < .001). The overall upstaging rate after laparoscopic surgery was 22.6% (95% confidence interval [CI], 18.1-27.9%) without significant heterogeneity among all study results. The overall incidence of conversion from laparoscopy to laparotomy was 3.7% (95% CI, 2.0-6.9%). The overall rate of recurrence in studies with a median follow-up period of ≥19 months was 9.9% (95% CI, 6.7-14.4%). CONCLUSION: Through our quantitative analysis, we concluded that the operative outcomes of a laparoscopic approach in patients with early-stage ovarian cancer could be compatible with those of laparotomy. In the future, further randomized controlled trials may be needed.

Is single-port access laparoscopy less painful than conventional laparoscopy for adnexal surgery? A comparison of postoperative pain and surgical outcomes.

OBJECTIVE: This study aimed to compare postoperative pain and surgical outcomes after transumbilical single-port access (SPA) and conventional multiport laparoscopic surgery for adnexal lesions. METHODS: A retrospective case-control study was conducted matched by age, body mass index, and frequency of previous abdominal surgery. A total of 110 SPA laparoscopy patients (cases) were matched with a cohort of 107 patients who underwent conventional laparoscopy (controls) for benign adnexal lesions. SPA system consisted of a wound retractor, surgical glove, two 5-mm trocars, and one 11-mm trocar. Postoperative pain scores were measured immediately after surgery and at 6, 24, and 48 hours postsurgery using the numerical rating scale. RESULTS: Postoperative pain scores did not differ between the 2 groups (P = .552). However, higher number of painkiller administrations was observed in the SPA laparoscopy group (median 3 vs 1, P < .001). The type of surgery and intraoperative blood loss were the significant factors influencing the number of painkiller administrations after controlling for other parameters by linear regression (P < .0001). The SPA laparoscopy group had less intraoperative blood loss (45.3 vs 87.5 mL, P < .001) and shorter hospital stay (2.1 ± 0.8 vs 2.7 ± 1.0 days, P < .001) compared with the conventional laparoscopy group. Operative time and perioperative complications did not differ between groups. CONCLUSIONS: There was no difference in pain intensity between the SPA and conventional laparoscopic group in this study. Future trials are warranted to better define the benefits of SPA surgery in terms of postoperative pain.

Single-port laparoscopic surgery is applicable to most gynecologic surgery: a single surgeon's experience.

BACKGROUND: The aim of this study was to evaluate the use of single-port laparoscopic surgery in benign gynecologic diseases and to examine its impact on surgical outcomes. METHODS: The medical records of 500 consecutive patients who underwent laparotomy or laparoscopic surgery performed by a single surgeon for benign disease from August 2008 to October 2010 were retrospectively reviewed. RESULTS: The surgeries included hysterectomy (n = 239), adnexectomy (n = 212), and myomectomy (n = 51). The indications for surgery included adnexal lesions (48.1%), uterine fibroids (37.8%), preinvasive cervical disease (7.5%), and endometrial pathology (6.6%). Twenty-nine percent of the first 100 cases were single-port laparoscopic surgeries. The percentages increased in the second (62%), third (72%), fourth (71%), and last (86%) 100 cases. The percentages of laparotomy and multiport laparoscopy were 23% and 48%, respectively, in the first 100 cases; however, in the last 100 cases, the percentages dropped to 4% and 10%, respectively. A significant reduction in estimated blood loss and length of hospital stay was observed for all diseases. No differences were identified in the median operative time or complication rate over the study period. CONCLUSION: Single-port laparoscopic surgery can be applied to most benign gynecologic surgery without detrimental effects on clinical outcomes.

Two-port access versus conventional staging laparoscopy for endometrial cancer.

OBJECTIVE: The purpose of this study was to compare surgical outcomes of 2-port access (TPA) and conventional laparoscopy in staging operations for endometrial cancer. The ultimate goal of TPA system was to perform proper cancer operation with less invasive access and to complement technical limitations of minimally invasive surgery. METHODS: The TPA system consisted of a single multi-channel port system at the umbilicus and an ancillary 5-mm trocar in the suprapubic area. Twenty-one consecutive patients who underwent TPA staging laparoscopy for endometrial cancers were enrolled in the study. Data coming from this group of patients were prospectively collected and compared with those coming from 42 consecutive patients who underwent conventional staging laparoscopy for the same period. The selected patients were matched (1:2 ratio) to control patients based on age (± 5 years), body mass index, and tumor stage. RESULTS: Patient status was estimated in operative morbidity and surgical outcomes. All operations were completed laparoscopically, with no conversion to laparotomy. The TPA group had a significantly longer operating time (238 ± 51 minutes vs 188 ± 65 minutes; P = 0.001), more retrieved para-aortic lymph nodes (13 vs 5; P < 0.001), shorter postoperative hospital stay (5 vs 8 days; P = 0.001), and less postoperative pain (P = 0.045). There were no postoperative complications requiring further management. CONCLUSIONS: Two-port access staging laparoscopy using a single multi-channel port system could be a feasible procedure in selected patients with endometrial cancer with only minimal skin incisions. Prospective randomized trials will permit the evaluation of potential benefits of this minimally invasive surgical technique.

Robotic surgery in gynecologic cancer.

PURPOSE OF REVIEW: The development of robotic technology has facilitated the application of minimally invasive techniques for complex operations in gynecologic oncology. The objective of this article is to review the published literature regarding robotic surgery and its application to gynecologic cancer. RECENT FINDINGS: To date, 20 articles addressing radical hysterectomy, six articles of radical trachelectomy, seven articles of surgical procedure in advanced or recurrent cervical cancer, 14 articles of endometrial cancer staging, and two articles solely on ovarian cancer all performed robotically are published in the literature. The majority of publications on robotic surgery are still retrospective or descriptive in nature. However, the data for gynecologic cancer show comparable results of robotic surgery compared with laparoscopy or laparotomy in terms of blood loss, length of hospital stay, and complications. SUMMARY: Computer-enhanced technology with its associated benefits appears to facilitate the surgical approach for technically challenging operations performed to treat selected cases of cervical, endometrial, and ovarian cancer as evidenced by the current literature. Continued research and clinical trials are needed to further elucidate the equivalence or superiority of robot-assisted surgery to conventional methods in terms of oncologic outcome and patients' quality of life.

Safety and feasibility of laterally extended endopelvic resection for sarcoma in the female genital tract: a prospective cohort study.

OBJECTIVE: This study aims to evaluate the safety and feasibility of laterally extended endopelvic resection (LEER) for sarcoma in the female genital tract. METHODS: We prospectively recruited gynecologic cancer patients with sarcoma arising from female genital tract who underwent LEER at Seoul National University Hospital from December 2016 to March 2021. Clinicopathologic characteristics, surgical outcomes including postoperative complications and pain control, and survival outcomes of the patients were investigated. RESULTS: A total of nine patients were registered for this study. The median age was 56 years. Carcinosarcoma (n=2, 22%), leiomyosarcoma (n=2, 22%), and undifferentiated uterine sarcoma (n=2, 22%) were common histology types. Complete resection was achieved in 88.9%. The most common location of pelvic sidewall tumors was infra-iliac acetabulum (66.7%). The pathologic outcome showed a median tumor size of 9.0 cm and internal iliac vessel resection with pelvic sidewall muscle was performed in all patients. The median estimated blood loss was 1,600 mL (range, 300-22,300), and the patients were postoperatively admitted to the intensive care unit for median 1 day (range, 0-8). Complete response was observed in 44.4% (4/9) in radiologic studies after LEER, and median progression-free survival, treatment-related survival, and overall survival were 3.3, 19.6, and 98.9 months, respectively. CONCLUSION: LEER was feasible and safe in treating recurrent sarcoma presenting pelvic sidewall invasion with acceptable survival outcomes and manageable postoperative complications.

Long Non-coding RNA LOC285194 Promotes Epithelial Ovarian Cancer Progression via the Apoptosis Signaling Pathway.

BACKGROUND/AIM: To explore the molecular mechanism and clinical significance of a newly identified lncRNA LOC285194 in epithelial ovarian cancer (EOC). MATERIALS AND METHODS: LOC285194 transcript levels were analyzed in EOC cells compared to normal cells. Small interfering RNAs were used to suppress LOC285194 expression. Levels of apoptosis-related proteins were determined by western blot. LOC285194 expression in ovarian cancer and non-tumor tissues were compared with clinicopathologic and survival data. RESULTS: Knockdown of LOC285194 decreased cell migration and proliferation, enhanced reactive oxygen species production and resulted in increased levels of proteins of the extrinsic apoptotic signaling pathway. LOC285194 expression level was higher in ovarian cancer tissues compared to control. Overall survival was significantly shorter in patients with high LOC285194 expression. Lymph node metastasis and high LOC285194 expression were significant prognostic factors of mortality (HR=4.614 and 5.880; p=0.026 and p=0.002, respectively). CONCLUSION: LOC285194 can promote the progression of EOC via an anti-apoptotic mechanism. It may serve as a novel biomarker for predicting prognosis of EOC.

Hypoxia-induced Maspin Expression Affects the Prognosis of Ovarian Clear Cell Carcinoma.

BACKGROUND/AIM: To investigate the role of the expression of hypoxia-related genes on the prognosis of ovarian clear cell carcinoma (OCCC). MATERIALS AND METHODS: Basal mRNA levels of eight hypoxia-related genes were compared. Cell viability was assayed after treating ES-2 cells under hypoxic conditions. The mRNA and protein levels were evaluated after the induction of hypoxia and administration of increased doses of N-acetylcysteine (NAC). Finally, the prognostic role of their expression levels was evaluated in 61 patients with OCCC. RESULTS: The mRNA and protein levels of maspin increased gradually with the induction of hypoxia. Maspin protein expression decreased after treatment with paclitaxel and NAC. High expression of maspin was related to poor progression-free and overall survival in patients with OCCC (adjusted hazard ratios, 3.97 and 7.47; 95% confidence intervals=1.34-11.81, and 1.98-28.13). CONCLUSION: High expression of maspin induced by hypoxia might be associated with poor prognosis of OCCC.

Effect and safety of diluted vasopressin injection on bleeding during robot-assisted laparoscopic myomectomy: a protocol for a randomised controlled pilot trial.

INTRODUCTION: Even though the injection of diluted vasopressin into the uterus is expected to reduce intraoperative bleeding with decreased adverse effects during robot-assisted laparoscopic myomectomy (RALM), there is a lack of relevant trials to show its effect and safety. Thus, this study was designed to compare the effect and safety of vasopressin injection on bleedings based on dilution levels of vasopressin with constant volumes during RALM. METHODS AND ANALYSIS: This is a randomised controlled pilot trial, where a total of 39 patients will be randomly divided into three experimental groups in a 1:1:1 ratio. All patients will be classified into the three groups based on the dilution level of vasopressin: group 1-a solution prepared by mixing 20 units of vasopressin with 100 mL of normal saline to make a total of 100 mL; group 2-a solution prepared by mixing 20 units of vasopressin with 200 mL of normal saline to make a total of 100 mL and group 3-a solution prepared by mixing 20 units of vasopressin with 400 mL of normal saline to make a total of 100 mL. During RALM, we will inject diluted vasopressin at different concentrations with a total of 100 mL. As the primary endpoint, estimated blood loss would be compared. As secondary endpoints, we will check the level of haemoglobin and haematocrit, operation time, amount of transfusion, and the period of hospitalisation. In addition, we will check other complications related to vasopressin injection. ETHICS AND DISSEMINATION: This pilot study has been approved by the Institutional Review Board of the Seoul National University Hospital (No. H-2011-107-1174). All potential subjects will be provided written informed consent. The results of this study will be published in peer-reviewed journals and be presented at academic conferences. TRIAL REGISTRATION NUMBERS: NCT04874246 and CKCT0006225.