Morbidity following robot-assisted surgery in a gynecological oncology setting: A cohort study.

INTRODUCTION: The objective of the study was to provide a comprehensive description of perioperative morbidity associated with robot-assisted surgery (RAS) in a gynecological oncology setting in order to improve the preoperative counseling of women and support shared decision-making. MATERIAL AND METHODS: All women scheduled for intended RAS between January 2015 and December 2022 were prospectively included in an electronic morbidity database for the analyses of perioperative complications. RESULTS: In total, 2225 women were included. Sixty-four patients (2.9%) experienced an intraoperative complication. Intraoperative complications were associated with a higher rate of conversion to laparotomy (15.6% vs. 1.8%, p < 0.001), a higher rate of major postoperative morbidity (9.3% vs. 2.4%, p < 0.001), and a higher rate of reoperation (9.3% vs. 1.7%, p < 0.001), compared to cases without intraoperative complications. Thirty-day postoperative morbidity was evaluated according to the Memorial Sloan-Kettering Cancer Center Surgical Secondary Events Grading System. Grade 3-5 events were considered major. A total of 57 patients (2.6%) experienced a major event after surgery, postoperative rupture of the vaginal vault being the most common complication requiring surgical intervention. Conversion to laparotomy occurred in 49 cases (2.2%) and was associated with higher intraoperative blood loss (300 mL vs. 25 mL, p < 0.001), a higher rate of postoperative major events (20.4% vs. 2.2%, p < 0.001), and a higher rate of reoperation (11.8% vs. 1.6%, p < 0.001). CONCLUSIONS: Our study demonstrates low rates of major perioperative morbidity and conversion to laparotomy after RAS performed by trained high-volume surgeons in a gynecological oncology setting.

Impact of FRAilty screening and Geriatric assessment and INtervention in older patients with epithelial Ovarian Cancer: A multicenter randomized clinical trial protocol (FRAGINOC).

INTRODUCTION: Radical surgery combined with chemotherapy is the only potential curative treatment of patients with advanced epithelial ovarian cancer (EOC). However, 43% of older Danish patients with EOC are not referred to surgery due to frailty, age, or fear of complications. Comprehensive geriatric assessment (CGA) has demonstrated ability to reduce frailty in older patients, but there is a knowledge gap regarding its effect before or during treatment in older adults with EOC. This protocol presents a randomized controlled trial (RCT), which evaluates the effect of CGA-based interventions including individualized physical exercise therapy in older adults with EOC during neoadjuvant chemotherapy (NACT). MATERIALS AND METHODS: This RCT will include patients aged ≥70 years with primary EOC referred to NACT. Patients will be randomized 1:1 to intervention or standard of care, along with neoadjuvant antineoplastic treatment. Stratification for performance status and center of inclusion will be performed. In the intervention arm, a geriatrician will perform CGA and corresponding geriatric interventions and patients will undergo an individualized home-based exercise program managed by a physiotherapist. All patients will be evaluated with Geriatric-8, modified Geriatric-8, clinical frailty scale, and physical tests at randomization. Predictive values (positive/negative) will be evaluated for CGA detected impairments. The primary endpoint is the proportion of patients referred to interval debulking surgery (IDS). Secondary endpoints include the proportion who complete oncological treatment, improvements in physical tests, quality of life measured by European Organization for Research and Treatment of Cancer-Quality of Life questionnaires at inclusion, after three cycles of chemotherapy, and at end of chemotherapy treatment. Furthermore, the association between results of geriatric screening tests, CGA, and physical tests with complication rate and progression free survival will be examined. The primary outcome will be analyzed with logistic regression in the intention-to-treat population. Power calculations reveal the need to enroll 216 patients. DISCUSSION: The present study examines whether CGA-based interventions including individualized physical exercise can increase the referral rate for potential curative IDS in older patients with EOC. If successful, this will result in more patients undergoing surgery and completing chemotherapy, preventing complications, and ultimately improving quality of life and survival. The study setup may establish the basis for direct clinical implementation if proven effective.

Social factors and age play a significant role in cervical cancer and advanced-stage disease among Danish women.

BACKGROUND: For cervical cancer (CC), the implementation of preventive strategies has the potential to make cervical cancer occurrence and death largely avoidable. To better understand the factors possibly responsible for cervical cancer, we aimed to examine possible differences in age and social parameters as well as screening status between women with low- or high-stage cervical cancer and matched controls. METHODS: Through the Danish Cancer Registry (DCR), women diagnosed with cervical cancer in Denmark between 1987 and 2016 were included. These were age- and residence-matched in a 1:5 ratio with controls from the general female population. The study population was sub grouped into a low-stage subpopulation with women with early-stage cervical cancer and matched controls and a high-stage subpopulation with women with late-stage cervical cancer and matched controls. Age and social parameters were compared within the subpopulations as well as between low- and high-stage cases. For part of the study population, screening attendance was examined to compare differences in adherence. RESULTS: Overall, we found that the risk of cervical cancer is significantly increased in socially disadvantaged women and not least non-attenders in screening. Interestingly, the high-stage subpopulation was significantly older than the low-stage subpopulation (p < 0.001), and when examining the impact of age further, we found that for cervical cancer cases, the risk of having low-stage disease decreases significantly with increasing age, whereas the risk of having high-stage disease increases significantly with increasing age. In the screening cohort, significantly less cases than controls were attenders in screening with the most pronounced differences seen in the old subpopulation (women aged 50-64 years) and in the high-stage subpopulation (p-values all < 0.001). Interestingly, when examining the risk of CC for attenders and non-attenders, we demonstrated that many social parameters continue to influence the risk of cervical cancer, even in women attending screening. CONCLUSIONS: Older women, socially disadvantaged women, and non-attenders in screening are particularly vulnerable in terms of developing cervical cancer, especially high-stage disease. Therefore, improvements in the participating rate in screening as well as a revision of the current screening guidelines are needed.