The British journal of surgery
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Randomized Controlled Trial Multicenter Study Comparative Study
Quality of life in a randomized trial of early closure of temporary ileostomy after rectal resection for cancer (EASY trial).
A temporary ileostomy may reduce symptoms from anastomotic leakage after rectal cancer resection. Earlier results of the EASY trial showed that early closure of the temporary ileostomy was associated with significantly fewer postoperative complications. The aim of the present study was to compare health-related quality of life (HRQOL) following early versus late closure of a temporary ileostomy. ⋯ Although the randomized study found that early closure of the temporary ileostomy was associated with significantly fewer complications, this clinical advantage had no effect on the patients' HRQOL. Registration number: NCT01287637 (https://www.clinicaltrials.gov).
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Review Meta Analysis
Meta-analysis of microsatellite instability in relation to clinicopathological characteristics and overall survival in gastric cancer.
Several associations between microsatellite instability (MSI) and other clinicopathological factors have been reported in gastric cancer, but the results have been ambiguous. This systematic review and meta-analysis investigated the relationship between MSI and overall survival and clinicopathological characteristics of patients with gastric cancer. ⋯ MSI in gastric cancer was associated with good overall survival, reflected in several favourable clinicopathological tumour characteristics.
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Review Meta Analysis Comparative Study
Meta-analysis of metabolic surgery versus medical treatment for microvascular complications in patients with type 2 diabetes mellitus.
This study aimed to examine the effect of metabolic surgery on pre-existing and future microvascular complications in patients with type 2 diabetes mellitus (T2DM) in comparison with medical treatment. Although metabolic surgery is the most effective treatment for obese patients with T2DM regarding glycaemic control, it is unclear whether the incidence or severity of microvascular complications is reduced. ⋯ In patients with T2DM, metabolic surgery prevented the development of microvascular complications better than medical treatment . Metabolic surgery improved pre-existing diabetic nephropathy compared with medical treatment.
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Randomized Controlled Trial Multicenter Study Comparative Study
Randomized clinical trial of adjuvant gemcitabine chemotherapy versus observation in resected bile duct cancer.
Although some retrospective studies have suggested the value of adjuvant therapy, no recommended standard exists in bile duct cancer. The aim of this study was to test the hypothesis that adjuvant gemcitabine chemotherapy would improve survival probability in resected bile duct cancer. ⋯ The survival probability in patients with resected bile duct cancer was not significantly different between the gemcitabine adjuvant chemotherapy group and the observation group. Registration number: UMIN 000000820 (http://www.umin.ac.jp/).
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Multiple surgical procedures in a single patient are relatively common and lead to dependent (clustered) data. This dependency needs to be accounted for in study design and data analysis. A systematic review was performed to assess how clustered data were handled in inguinal hernia trials. The impact of ignoring clustered data was estimated using simulations. ⋯ Clustering was rarely considered in inguinal hernia trials. The simulations underline the importance of considering clustering as part of the statistical analysis to avoid false-positive and false-negative results, and hence inappropriate study conclusions.