Cost analysis in a randomized trial of early closure of a temporary ileostomy after rectal resection for cancer (EASY trial).

BACKGROUND: Hospital costs associated with the treatment of rectal cancer are considerable and the formation of a temporary stoma accounts for additional costs. Results from the EASY trial showed that early closure of a temporary ileostomy was associated with significantly fewer postoperative complications but no difference in health-related quality of life up to 12 months after rectal resection. The aim of the present study was to perform a cost analysis within the framework of the EASY trial. METHODS: Early closure (8-13 days) of a temporary stoma was compared to late closure (> 12 weeks) in the randomized controlled trial EASY (NCT01287637). The study period and follow-up was 12 months after rectal resection. Inclusion of participants was made after index surgery. Exclusion criteria were diabetes mellitus, steroid treatment, signs of postoperative complications or anastomotic leakage. Clinical effectiveness and resource use were derived from the trial and unit costs from Swedish sources. Costs were calculated for the year 2016 and analysed from the perspective of the healthcare sector. RESULTS: Fifty-five patients underwent early closure, and 57 late closure in eight Swedish and Danish hospitals between 2011 and 2014. The difference in mean cost per patient was 4060 US dollar (95% confidence interval 1121; 6999, p value < 0.01) in favour of early closure. A sensitivity analysis, taking protocol-driven examinations into account, resulted in an overall difference in mean cost per patient of $3608, in favour of early closure (95% confidence interval 668; 6549, p value 0.02). The predominant cost factors were reoperations, readmissions and endoscopic examinations. CONCLUSIONS: The significant cost reduction in this study, together with results of safety and efficacy from the randomized controlled trial, supports the routine use of early closure of a temporary ileostomy after rectal resection for cancer in selected patients without signs of anastomotic leakage. CLINICAL TRIAL: Registered at clinicaltrials.gov, clinical trials identifier NCT01287637.

5-year outcome after complete mesocolic excision for right-sided colon cancer: a population-based cohort study.

BACKGROUND: The benefits of extensive lymph node dissection as performed in complete mesocolic excision are still debated, although recent studies have shown an association with improved long-term outcomes. However, none of these studies had an intention-to-treat design or aimed to show a causal effect; therefore in this study, we aimed to estimate the causal oncological treatment effects of complete mesocolic excision on right-sided colon cancer. METHODS: We did a population-based cohort study involving prospective data collected from four hospitals in Denmark. We compared the oncological outcome data of patients at one centre performing central lymph node dissection and vascular division after almost complete exposure of the proximal part of the superior mesenteric vein (ie, the complete mesocolic excision group) with three other centres performing conventional resections with unstandardised and limited lymph node dissection (ie, non-complete mesocolic excision; control group). We included data for all patients in the Capital Region of Denmark undergoing elective curative-intent right-sided colon resections for stages I-III colon cancer, as categorised by the Union for International Cancer Control (UICC; 5th edition), from June 1, 2008, to Dec 31, 2013. Patients were followed-up for 5·2 years after surgery. The primary outcome was the cumulative incidence of recurrence after 5·2 years of surgery. Inverse probability of treatment weighting and competing risk analyses were used to estimate the possible causal effects of complete mesocolic excision. This study is registered with ClinicalTrials.gov, number NCT03754075. FINDINGS: 1069 patients (813 in the control group and 256 in the complete mesocolic excision group) underwent curative-intent elective surgery for right-sided colon cancer during the study period. None of the patients were lost to follow-up regarding survival or recurrence status, and consequently no patient was censored in the analyses. The 5·2-year cumulative incidence of recurrence was 9·7% (95% CI 6·3-13·1) in the complete mesocolic excision group compared with 17·9% (15·3-20·5) in the control group, and the absolute risk reduction of complete mesocolic excision after 5·2 years was 8·2% (95% CI 4·0-12·4; p=0·00015). In the control group, 145 (18%) of 813 patients were diagnosed with a recurrence and 281 (35%) died during follow-up, whereas in the complete mesocolic excision group 25 (10%) of 256 patients were diagnosed with a recurrence and 75 (29%) died during follow-up. INTERPRETATION: This study shows a causal treatment effect of central mesocolic lymph node excision on risk of recurrence after resection for right-sided colon adenocarcinoma. Complete mesocolic excision has the potential to reduce the risk of recurrence and improve long-term outcome after resection for all UICC stages I-III of right-sided colon adenocarcinomas. FUNDING: The Tvergaard Fund, Helen Rude Fund, Krista and Viggo Petersen Fund, Olga Bryde Nielsen Fund, and Else and Mogens Wedell-Wedellsborg Fund.

Early Closure of a Temporary Ileostomy in Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial.

OBJECTIVE: The objective was to study morbidity and mortality associated with early closure (8-13 days) of a temporary stoma compared with standard procedure (closure after > 12 weeks) after rectal resection for cancer. BACKGROUND: A temporary ileostomy may reduce the risk of pelvic sepsis after anastomotic dehiscence. However, the temporary ileostomy is afflicted with complications and requires a second surgical procedure (closure) with its own complications. Early closure of the temporary ileostomy could reduce complications for rectal cancer patients. METHODS: Early closure (8-13 days after stoma creation) of a temporary ileostomy was compared with late closure (>12 weeks) in a multicenter randomized controlled trial, EASY (www.clinicaltrials.gov, NCT01287637) including patients undergoing rectal resection for cancer. Patients with a temporary ileostomy without signs of postoperative complications were randomized to closure at 8 to 13 days or late closure (>12 weeks after index surgery). Clinical data were collected up to 12 months. Complications were registered according to the Clavien-Dindo Classification of Surgical Complications, and Comprehensive Complication Index was calculated. RESULTS: The trial included 127 patients in eight Danish and Swedish surgical departments, and 112 patients were available for analysis. The mean number of complications after index surgery up to 12 months follow up was significantly lower in the intervention group (1.2) compared with the control group (2.9), P < 0.0001. CONCLUSIONS: It is safe to close a temporary ileostomy 8 to 13 days after rectal resection and anastomosis for rectal cancer in selected patients without clinical or radiological signs of anastomotic leakage.

Childhood adversities: Social support, premorbid functioning and social outcome in first-episode psychosis and a matched case-control group.

OBJECTIVE: The establishment of childhood adversities as risk factors for non-affective psychosis has derived a need to consider alternative interpretations of several psychosis-related factors. This paper sought to examine premorbid adjustment trajectories and social outcome factors in relation to childhood adversities. Perceived support has been found to decrease the risk of post-traumatic stress disorder, and we wished to compare perceived support in people with first-episode psychosis to non-clinical control persons and explore its relation to childhood adversities. METHOD: Every individual presenting with a non-affective first-episode psychosis (F20-29, except F21) in Region Zealand over a 2-year period was approached for participation and the 101 consenting participants were matched to 101 people with no psychiatric disorders. Comprehensive demographic data were collected. Assessment instruments included the Premorbid Assessment Scale, the Global Assessment of Functioning scale and the Childhood Trauma Questionnaire. The latter represented the childhood adversities in addition to parental separation and institutionalization. RESULTS: There were no associations between number of childhood adversities and different social or academic premorbid trajectories. Those with more adversities had lower global functioning the year prior to treatment start and reported lower rates of perceived support during childhood along with less current face-to-face contact with family members. Lack of peer support remained a significant predictor of psychosis when adversities were adjusted for; peer support diminished the risk of psychosis caused by childhood adversities by 10%. CONCLUSION: Childhood adversities may not predict specific premorbid trajectories, but have an effect on global functioning when the psychosis has begun. Perceived support, especially from peers, may be important in the development of psychosis, and those with more adversities may represent a vulnerable subgroup who need more assistance to increase and maintain supportive networks.

Lymph node metastases in the gastrocolic ligament in patients with colon cancer.

BACKGROUND: Long-term survival after colorectal cancer may be improved by more extensive resection of the primary tumor and lymph nodes. Resection of the gastroepiploic and infrapyloric lymph nodes in the gastrocolic ligament has been proposed as a standard procedure when resecting tumors located in the proximity of the flexures or in the transverse colon. OBJECTIVE: The purpose of this work was to present our findings of metastases in the gastrocolic ligament in a consecutive series of patients. DESIGN: This was a single-center retrospective study. SETTINGS: The study was conducted in a colorectal cancer center. PATIENTS: All of the colon adenocarcinoma resections with relevant tumor location from June 1, 2008, to December 31, 2012 were included in this study. MAIN OUTCOME MEASURES: The presence of lymph node metastases in the gastrocolic ligament in colon adenocarcinomas located in the proximity of the flexures or in the transverse colon was measured. RESULTS: Gastrocolic resection was performed in 130 patients. Thirty-two patients were excluded because of a lack of information about gastrocolic lymph node status in the pathology reports. Median age of the remaining 98 patients was 70 years (range, 30-90 years), and 57% were men. Gastrocolic lymph nodes were found in 86 specimens (88%) with a median number of 4 lymph nodes (range, 0-16 lymph nodes). Thirty-four patients (35%) had mesocolic lymph node metastases. Gastrocolic lymph node metastases were found in 4 (12%) of these 34 patients and in 4% of all 98 included patients. Gastrocolic lymph node metastases were related to perineural invasion (p > 0.001). LIMITATIONS: Limitations of this study include the retrospective design, size of material, and lack of gastrocolic ligament lymph node status in the pathology report in some patients. CONCLUSIONS: Metastases in the gastroepiploic or infrapyloric lymph nodes can be found in patients with tumors located in the proximity of the flexures or in the transverse colon. Further studies are needed to reveal the clinical relevance of this finding, with special focus on recurrence risk and long-term survival.

Psychological Flexibility as a Buffer against Caregiver Distress in Families with Psychosis.

Background: Research has shown that caregivers of persons with psychosis play an invaluable role in recovery, but unfortunately, often report high levels of distress. While cognitive models of caregiver distress have been well-supported, there is still limited knowledge of the psychological factors involved. Recent advances in cognitive behavioral therapy seem to converge on the importance of acceptance- and mindfulness based processes. Aim: To examine the impact of psychological flexibility on caregiver distress in the early phases of psychosis, while controlling for known predictors of caregiver distress. Method: Within a cross-sectional design, 101 caregivers of 38 persons with first-episode psychosis in a clinical epidemiological sample completed a series of self-report measures. Results: A linear mixed model analysis found that, after controlling for caregiver socio-demographic factors, service user symptoms, drug use and global functioning, psychological flexibility was a significant predictor of caregiver distress. Conclusion: Greater level of psychological flexibility in caregivers, seems to be related to lower levels of caregiver distress. This finding corresponds to studies within a broad range of emotional disorders. There may be important clinical implications in terms of facilitating the process of acceptance through interventions from the 'third-wave' or contextual cognitive behavioral therapies.

Positive and negative caregiver experiences in first-episode psychosis: emotional overinvolvement, wellbeing and metacognition.

OBJECTIVES: While caregivers of persons with first-episode psychosis often report a range of negative experiences, little is known about what psychological factors are involved. The aim of this study was to examine how caregivers' general wellbeing, emotional overinvolvement and metacognition influenced their reports of both positive and negative caregiving experiences. DESIGN: A prospective consecutive cross-sectional study. METHODS: Forty caregivers of patients with first-episode psychosis were interviewed using semi-structured interview and questionnaires. RESULTS: Greater levels of distress and overinvolvement were associated with more negative experiences of caregiving while greater metacognitive capacity was associated with more positive experiences of caregiving. CONCLUSIONS: The experience of positive and negative aspects of caregiving seems to be associated with different variables. Greater metacognitive capacity does not necessarily alleviate the suffering and distress, which is a healthy and normal reaction to having a close one suffering from psychosis. But it might help broaden the perspective, allowing for both negative and positive experiences. Clinical implications in terms of expanding the range of therapeutic interventions are discussed. PRACTITIONER POINTS: Assessing the capacity for metacognition in a non-clinical population. Understanding what factors are involved in positive and negative caregiver experiences in first-episode psychosis. A broadening of family interventions by encompassing the concept of metacognition.