Study Population. Infants who underwent creation of an enterostomy receiving postoperative care and awaiting enterostomy closure: to be assessed for eligibility: n = 201 to be assigned to the study: n = 106 to be analysed: n = 106 Duration of intervention per patient of the intervention group: 6 weeks between enterostomy creation and enterostomy closure Follow-up per patient: 3 months, 6 months and 12 months post enterostomy closure, following enterostomy closure (12-month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 month of overall study duration).
Study Population. All patients who underwent elective surgery with primary anastomosis creation for a first primary colon carcinoma between January the 1, 2013 and December the 31, 2019, and registered in the DCRA were potentially eligible. Data extracted from the DCRA comprised characteristics concerning patient, tumor, surgical and follow−up information. The 30−day follow−up was registered until December 31, 2017, and from January 1, 2018, the 90−day follow−up was registered. Index surgical procedures were divided into right hemicolectomy, transversectomy, left hemicolectomy, sigmoid resection, and subtotal colectomy. AL was defined as a defect of the intestinal wall or abscess at the site of the colorectal anastomosis, for which a reintervention was required within 30 to 90−days from primary resection. Since the date of AL diagnosis is not available in the DCRA, the present study reports the follow−up from index colectomy to reintervention. Reinterventions were divided into two categories: (1) surgical reinterventions including laparoscopic and open surgical reinterventions, and (2) non−surgical reinterventions including radiologic−, endoscopic−, and other unspecified reinterventions. For each type of index colectomy, the occurrence of AL, type of reintervention, and timing of reintervention were determined. Primary outcomes after reoperation were mortality, ICU admission, and stoma construction. Secondary outcomes were prolonged hospital stay (primary admission of >14 days after index procedure), readmission, stoma creation per type (defunctioning ileo or colostomy, end ileo or colostomy), and mortality for patients with and without stoma creation during reoperation. Baseline study population characteristics are reported for patients with and without AL. Outcomes after reoperation were reported for the total study population and for each type of index colectomy. Sub−analyses were performed to assess differences in outcomes for reoperation performed during the weekend vs. week and for different annual hospital volumes. Since the Dutch standard states that hospitals should perform at least 50 colonic resections per year,19 volumes were categorized into low− (<50), low−intermediate (50−75), intermediate−high (76−100), and high (>100 ) volume hospitals. Categorical and dichotomous variables are reported as absolute numbers with percentages and were compared using the Xxxxxxx Xxx−square test or Xxxxxx−Exact test. Continuous variables are reported as median with interquartile...
Study Population. All patients who underwent surgery for first primary colon cancer between January the 1, 2013 and December the 31, 2019, and registered in the DCRA were potentially eligible for this study (N=52,035) (Figure 1). For the purpose of this study, the following patients were excluded: patients with a synchronous colorectal carcinoma (N=1,770), patients who underwent emergency surgery (N=6,806), underwent a local excision (N=39), patients in whom no primary anastomosis was constructed (N=2,659), patients with a prior stoma of any type as bridge to surgery which was not reversed during the elective colectomy or patients with a stoma of any type constructed during elective colectomy (N=1,178), patients with missing data on AL (N=3), and proctocolectomy (N=15) were excluded. After exclusion, a total of 39,565 patients were included in the study. E l e c t i v ec ca on lco enr s u r g p r i m a r y a n a s t o m o s i s N = 3 9 , 5 6 5 T o tnau lm b ecor loocfna n c e r p a t i who u n d e r swu re gnet r y -(202 10 91 )3 N = 5 2 , 0 3 5 E x c l u s i o n : - S y n c h r o n o u s C R C , N = 1 , 7 7 0 - E m e r g e n c y s e t t i n g , N = 6 , 8 0 6 - L o c a l e x c i s i o n , N = 3 9 - N o p r i m a r y a n a s t o m o s i s , N = 2 , 6 5 9 - M i s s i n g c a s e s f o r A L , N = 3 - P r o c t o c o l e c t o m y , N = 1 5 Figure 1 presents the flowchart of the present study. Synchronous CRC: synchronous colorectal cancer, AL: anastomotic leakage. The overall AL rate was 4.8% and baseline characteristics are displayed in Table 1. Compared to patients without AL, thosewith ALwere more frequently male (62.5% vs. 52.2%, p<0.001), obese (BMI ≥30 kg/m2 22.7% vs. 19.9%, p=0.009), less healthy (ASA III+ 31.7% vs. 24.8%, p<0.001; CCI II+ 32.7% vs. 28.0%, p<0.001), more often presented with tumor−related complications such as anemia or peritumoral abscess (32.7% vs. 27.4%, p=0.006) and had a more advanced tumor stage (T4 13.5% vs. 10.0%, p<0.001 and M1 11.0% vs. 7.4%, p<0.001). Regarding treatment characteristics, these patients more often received neoadjuvant chemotherapy (3.1% vs.1.6%, p<0.001), more often underwent an open resection (23.8% vs. 16.5%, p<0.001), a multivisceral resection (11.5% vs. 6.5%, p<0.001) or an additional resection for metastasis (5.5% vs. 2.8%, p<0.001). The total number of patients treated at low−volume hospitals was 5,564, which was 7,454 for low-intermediate volume hospitals, 8,163 for intermediate-high volume hospitals, and 18,384 for hi...
Study Population. This retrospective, single-center study was conducted in accordance with the Declaration of Helsinki (as revised in 2013) and was approved by the Ethics Committee of Fudan University Shanghai Cancer Center. Informed consent was obtained from all individual participants. From March 2017 to June 2022, 147 patients who underwent RP after neoadjuvant ADT and presurgical MRI examinations were retrieved from our picture archiving and communication system according to the following criteria 147 PCa patients undergoing ADT before RP Inclusion • Clinically significant PCa as confirmed by biopsy before ADT • With post-ADT pathology confirmed by RP • Mp-MRI scans within 2 weeks before RP • More than 3 months with a complete androgen blockade with bicalutamide plus ADT Final study population (n=119) Exclusion • Any type of chemotherapy or RT before RP (n=18) • Inadequate image quality (n=10) (Figure 1).
Study Population. Subjects with postmenopausal osteoporosis who completed the End-of-Treatment Visit (Visit 9) for Study BA058-05-003 and were previously randomized to either blinded Abaloparatide-SC or blinded Placebo are eligible for inclusion into this Extension Study provided that they fulfill the Inclusion/Exclusion criteria described below.
Study Population. The study population in this protocol is comprised of otherwise healthy ambulatory postmenopausal women who:
1. have participated in Study BA058-05-003, 2. were randomized to either BA058 Injection 80 µg/Placebo,
Study Population. 490 schools from the canton of Zurich were invited and 37 participated. 3870 children aged 6-17 years took part. For 3079 we had questionnaires with information on wheeze and exertional wheeze from both parents and children (Table 1). FeNO results were available for 2762 children (median 12ppb, interquartile range [IQR] 7-21) and FVC measurements for 2217 (median 87%, IQR 82-91). Most questionnaires were completed by the mothers (n=1765, 57%). 667 children (22%) helped their parents to complete the questionnaire. Parents of 425 children (14%) had a history of asthma. Table 1: Sociodemographic characteristics of schoolchildren in the XXXX study (N=3079). n (%) Male sex 1519 (49) Age in years, median (range) 12.3 (6.0-17.2) Who answered the parental questionnaire Mother alone 1765 (57) Father alone 406 (13) Mother and father 202 (7) One or both parents and the child 667 (22) Other 28 (1) Child born in Switzerland 2726 (89) Mother born in Switzerland 1764 (58) Father born in Switzerland 1859 (60) Number of children per household One or two 2073 (67) More than two 926 (30) Urbanisation degree Large urban area 1338 (44)
Study Population. All subjects will have a histologically-confirmed diagnosis of GBM (WHO Grade IV), and an unmethylated MGMT status, as confirmed by PCR or alternative genomic analysis. Prior to study entry, subjects will have had optimal surgical resection and subsequent treatment with radiotherapy and temozolomide, in accordance with the ‘Xxxxx regimen’. Subjects who have had disease progression or recurrence subsequent to radiotherapy treatment will not be eligible. Other eligibility criteria will be as commonly deployed for oncology studies. Both male and female subjects will be recruited.
Study Population. The study population in this protocol is the population recommended by Regulatory Authorities (17-19) for the clinical evaluation of PTH and PTH-like drugs in this indication: postmenopausal women (50 to 85 years of age) who are more than 5 years post menopause and whose menopause has been confirmed by an elevated serum FSH and a BMD T-score of <-2.5 (2.5 SD below the population norm) and > -5.0 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA) and radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic vertebral fractures, or history of low trauma forearm, humerus, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years. However, postmenopausal women older than 65 who meet the above fracture criteria but have a T-score < -2.0 and > -5.0 may be enrolled. In addition, women older than 65 who do not meet the fracture criteria may also be enrolled if their T-score is <-3.0 and > -5.0. Women who are intolerant of bisphosphonates as outlined in exclusion criterion # 17 (Section 0) and meet the above criteria will also be allowed to enroll. Based on midpoint demographics of the proposed study population, the anticipated 10-year fracture rate in Study BA058-05-003 is estimated to fall within the recommended ranges in the relevant guideline (CPMP/EWP/552/95 Rev.2) when calculated using the FRAX assessment tool (xxxx://xxx.xxxx.xx.xx/FRAX/). A sample size of 622 patients per treatment arm provides 90% power at a two-sided alpha of 0.05 to detect a difference of 4% between treatments, assuming a vertebral fracture rate of 7% in placebo patients and 3% in BA058 80 µg for injection-treated patients when the large scale approximation of the binomial method is employed. This superiority assessment infers a relative risk reduction of 57% and presupposes the availability of a pretreatment and post-treatment radiological assessment. To ensure a per protocol population of 622 patients, an overall sample size of 800 patients per treatment arm will be recruited, anticipating that approximately 20% of patients may not have a second evaluable X-ray film available for analysis. Prior studies have demonstrated that approximately 20% of enrolled patients drop out over the lengthy period of the study and a further proportion (10%) fail to provide an evaluable End-of-Treatment X-ray, therefore a sample size of 800 patients per arm is proposed.
Study Population. This study was performed in a single university center and was approved by our institutional review board. Written informed consent was obtained from all patients. All patients with clinical suspicion of CAD and after a cardiological evaluation were prospectively included.
