Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries

Background: Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks. Methods: The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned. Results: A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P < 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31). Conclusion: Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov)

Littoral cell angioma of the spleen: case report and literature review

Conclusions Long-term follow-up for suspicious malignant potential is advised

Assessment of ovarian reserve with anti-Mullerian hormone in women following allogeneic hematopoietic cell transplantation

Introduction: Severe ovarian failure and persistent infertility have could be seen in females following allogeneic hematopoietic cell transplantation (allo-HCT.) In this study, the authors aimed to determine the effectiveness of AMH on assessment of ovarian reserve in long-term survivors after allo-HCT. Material and Methods: Female patients, who underwent allo-HCT between August 2009 and February 2016, were retrospectively evaluated for ovarian capacity in long-term follow-up. Twenty-one female patients with a median age of 34 (22-45) years were included in the study. The serum levels of estrogen (E2), follicle stimulated hormone (FSH), luteinizing hormone (LH), and AMH were analysed. Results: The median duration of post-transplant follow-up was 37 (12-84) months. Primary ovarian failure (POF) was detected in eight (38,1%) and 19 (90,4%) cases in the pre-transplant and post-transplant period, respectively. It was found that no menstruation cycles were observed in 18 cases with low AMH levels. Discussion: Regular menstrual cycles may not guarantee the fertilization in the post-transplant period. Combined analysis of hormonal investigations, antral follicle count by vaginal USG, and evaluation of serum AMH levels may be preferred to demonstrate the presence of POF

Is Cytomegalovirus Surveillance Necessary for Patients With Low Reactivation Risk in an Autologous Hematopoietic Cell Transplantation Setting?

Background In an autologous hematopoietic cell transplantation (AHCT) setting, routine cytomegalovirus (CMV) surveillance is not indicated except in high-risk situations. On the other hand, some studies reported increased CMV reactivation in AHCT setting as a result of incorporation of novel agents into treatment algorithms, such as bortezomib and rituximab. We retrospectively analyzed CMV reactivation and infection rates in patients with no high-risk features, who were treated with AHCT. Methods During January 2010 to November 2015, all consecutive, CMV-seropositive patients were included. The viral copy numbers were measured twice a week from the start of the conditioning regimen until engraftment, once a week for the remaining time period until day 30 after AHCT and once weekly only for patients who had been diagnosed with CMV reactivation before and who developed primary/secondary engraftment failure during 31 to 60 days after AHCT. Results One hundred one (61.6%) men and 63 (38.4%) women were included in the study. The median age of study cohort was 51 years (range, 16–71 years). The indications for AHCT were Hodgkin lymphoma, non-Hodgkin lymphoma, and multiple myeloma in 44 (26.8%), 41 (25%), and 79 (48.2%) patients, respectively. CMV reactivation occurred in 60 (37%) patients, and 13 patients (8%) received pre-emptive ganciclovir treatment. Conclusions On the basis of our results, it might be stated that CMV surveillance may be recommended during 40 days after AHCT in countries with a high CMV prevalence, even in patients without high-risk features regarding reactivation. Additionally, the risky conditions necessitating CMV screening after AHCT must be re-defined in the era of novel agents

with chronic myeloid leukemia: A retrospective multicenter study

AimsWe aimed to investigate whether older age leads to limitations in the starting dose of imatinib in daily treatment of chronic myeloid leukemia, and to determine the compliance of elderly patients with tyrosine kinase inhibitors (TKI) therapy.MethodsData including the clinical characteristics, therapeutic outcomes and compliance with TKI therapy of elderly patients with chronic myeloid leukemia aged >65years were collected from 13 institutions in Turkey, retrospectively.ResultsA total of 69 patients (27 [39%] men, 42 [61%] women) were evaluated retrospectively. The median age of the patients was 71years (range 66-85years). Of the patients, 66 (96%) were in the chronic phase and three (4.3%) were in the accelerated phase when diagnosed. A total of 63 (91.3%) patients were receiving imatinib as the first-line therapy. The initial dose of imatinib was 400mg/day in 59 patients (93.6%). Imatinib treatment induced 57 (90.5%) complete hematological responses at 3months, 29 (46%) complete cytogenetic responses at 6months and 49 (77.7%) major molecular responses at 12months. As a result, nilotinib and dasatinib were used in 14 patients as second-line therapy. Second-line TKI induced nine complete hematological responses (64.3%) at 3months, four complete cytogenetic responses (28.6%) at 12months and seven major molecular responses (50%) at 18months. A total of 56 of the patients (81.2%) are still alive. The median overall survival and progression-free survival rates were 35months (range 1-95months) and 17months (range 0.8-95months), respectively.ConclusionElderly patients should receive TKI according to the same guidelines that apply to younger patients. Geriatr Gerontol Int 2015; 15: 729-735

The Real-World Experience With Single Agent Ibrutinib in Relapsed/Refractory CLL

We evaluated the safety and efficacy of single-agent ibrutinib in 200 patients presenting with relapsed/refractory CLL in real-world settings. With an estimated median OS of 52 months, 146 patients (75%) achieved at least PR; 16 (8.7%) patients discontinued ibrutinib due to adverse events. The results indicate good safety and efficacy for single-agent ibrutinib in R/R CLL in daily practice. Introduction/Background: The emergence of novel agents targeting the B-cell receptor pathway and BCL-2 has significantly changed the therapeutic landscape of CLL. We evaluated the safety and efficacy of single-agent ibrutinib in relapsed/refractory CLL in real-world settings. Patients/Methods: A total of 200 relapsed/refractory CLL patients with a median age of 68 were included in this retrospective, multicenter, non-interventional study. Data of the study were captured from the patient charts of the par ticipating centers. Results: The median for lines of previous chemotherapy was 2 (1-6); 62 (31.8%) patients had del17p and/or p53 mutations (del17p+ /p53mut). Of the study group, 146 (75%) patients achieved at least PR, while 16 (8.7%) patients discontinued ibrutinib due to TEA. The most common drug-related adverse events were neutropenia (n: 31; 17.4%) and thrombocytopenia (n: 40; 22.3%), which were >= grade 3 in 9 (5%) and 5 (3.9%) patients, respectively. Pneumonia (n: 42; 23.7%) was the most common nonhematologic TEA. Atr ial fibrillation (n: 5; 2.8%) and bleeding (n: 11; 6.3%) were relatively rare dur ing the study period. Within a median follow-up period of 17 (1-74) months, 42 (21%) patients died. The estimated median OS of the study cohort was 52 months. Only the response to ibrutinib (CR/PR vs. SD/PD) was significantly associated with OS. Conclusion: Our results indicate good safety and efficacy for single-agent ibrutinib in R/R CLL in daily practice. (C) 2021 Elsevier Inc. All rights reserved