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      Similarities and differences between study designs in short‐ and long‐term outcomes of laparoscopic versus open low anterior resection for rectal cancer: A systematic review and meta‐analysis of randomized, case‐matched, and cohort studies

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          Abstract

          Aim

          Randomized controlled trials (RCT) are the gold standard in surgical research, and case‐matched studies, such as studies with propensity score matching, are expected to serve as an alternative to RCT. Both study designs have been used to investigate the potential superiority of laparoscopic surgery to open surgery for rectal cancer, but it remains unclear whether there are any differences in the findings obtained using these study designs. We aimed to examine similarities and differences between findings from different study designs regarding laparoscopic surgery for rectal cancer.

          Methods

          Systematic review and meta‐analyses. A comprehensive literature search was conducted using PubMed, Scopus, and Cochrane. RCT, case‐matched studies, and cohort studies comparing laparoscopic low anterior resection and open low anterior resection for rectal cancer were included. In total, 8 short‐term outcomes and 3 long‐term outcomes were assessed. Meta‐analysis was conducted stratified by study design using a random‐effects model.

          Results

          Thirty‐five studies were included in this review. Findings did not differ between RCT and case‐matched studies for most outcomes. However, the estimated treatment effect was largest in cohort studies, intermediate in case‐matched studies, and smallest in RCT for overall postoperative complications and 3‐year local recurrence.

          Conclusion

          Findings from case‐matched studies were similar to those from RCT in laparoscopic low anterior resection for rectal cancer. However, findings from case‐matched studies were sometimes intermediate between those of RCT and unadjusted cohort studies, and case‐matched studies and cohort studies have a potential to overestimate the treatment effect compared with RCT.

          Abstract

          This article reports on similarities and differences in findings of randomized controlled trials (RCTs), case‐matched studies, and cohort studies, as revealed by meta‐analyses of previously published studies on laparoscopic low anterior resection (LAR) for rectal cancer. Results of case‐matched studies were often similar to those of RCTs in terms of outcomes of laparoscopic LAR for rectal cancer. However, case‐matched studies occasionally overestimate the effects of interventions compared to RCTs.

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          Most cited references53

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          Estimating the mean and variance from the median, range, and the size of a sample

          Background Usually the researchers performing meta-analysis of continuous outcomes from clinical trials need their mean value and the variance (or standard deviation) in order to pool data. However, sometimes the published reports of clinical trials only report the median, range and the size of the trial. Methods In this article we use simple and elementary inequalities and approximations in order to estimate the mean and the variance for such trials. Our estimation is distribution-free, i.e., it makes no assumption on the distribution of the underlying data. Results We found two simple formulas that estimate the mean using the values of the median (m), low and high end of the range (a and b, respectively), and n (the sample size). Using simulations, we show that median can be used to estimate mean when the sample size is larger than 25. For smaller samples our new formula, devised in this paper, should be used. We also estimated the variance of an unknown sample using the median, low and high end of the range, and the sample size. Our estimate is performing as the best estimate in our simulations for very small samples (n ≤ 15). For moderately sized samples (15 70), the formula range/6 gives the best estimator for the standard deviation (variance). We also include an illustrative example of the potential value of our method using reports from the Cochrane review on the role of erythropoietin in anemia due to malignancy. Conclusion Using these formulas, we hope to help meta-analysts use clinical trials in their analysis even when not all of the information is available and/or reported.
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            The Central Role of the Propensity Score in Observational Studies for Causal Effects

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              Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial.

              Laparoscopic surgery as an alternative to open surgery in patients with rectal cancer has not yet been shown to be oncologically safe. The aim in the COlorectal cancer Laparoscopic or Open Resection (COLOR II) trial was to compare laparoscopic and open surgery in patients with rectal cancer. A non-inferiority phase 3 trial was undertaken at 30 centres and hospitals in eight countries. Patients (aged ≥18 years) with rectal cancer within 15 cm from the anal verge without evidence of distant metastases were randomly assigned to either laparoscopic or open surgery in a 2:1 ratio, stratified by centre, location of tumour, and preoperative radiotherapy. The study was not masked. Secondary (short-term) outcomes-including operative findings, complications, mortality, and results at pathological examination-are reported here. Analysis was by modified intention to treat, excluding those patients with post-randomisation exclusion criteria and for whom data were not available. This study is registered with ClinicalTrials.gov, number NCT00297791. The study was undertaken between Jan 20, 2004, and May 4, 2010. 1103 patients were randomly assigned to the laparoscopic (n=739) and open surgery groups (n=364), and 1044 were eligible for analyses (699 and 345, respectively). Patients in the laparoscopic surgery group lost less blood than did those in the open surgery group (median 200 mL [IQR 100-400] vs 400 mL [200-700], p<0·0001); however, laparoscopic procedures took longer (240 min [184-300] vs 188 min [150-240]; p<0·0001). In the laparoscopic surgery group, bowel function returned sooner (2·0 days [1·0-3·0] vs 3·0 days [2·0-4·0]; p<0·0001) and hospital stay was shorter (8·0 days [6·0-13·0] vs 9·0 days [7·0-14·0]; p=0·036). Macroscopically, completeness of the resection was not different between groups (589 [88%] of 666 vs 303 [92%] of 331; p=0·250). Positive circumferential resection margin (<2 mm) was noted in 56 (10%) of 588 patients in the laparoscopic surgery group and 30 (10%) of 300 in the open surgery group (p=0·850). Median tumour distance to distal resection margin did not differ significantly between the groups (3·0 cm [IQR 2·0-4·8] vs 3·0 cm [1·8-5·0], respectively; p=0·676). In the laparoscopic and open surgery groups, morbidity (278 [40%] of 697 vs 128 [37%] of 345, respectively; p=0·424) and mortality (eight [1%] of 699 vs six [2%] of 345, respectively; p=0·409) within 28 days after surgery were similar. In selected patients with rectal cancer treated by skilled surgeons, laparoscopic surgery resulted in similar safety, resection margins, and completeness of resection to that of open surgery, and recovery was improved after laparoscopic surgery. Results for the primary endpoint-locoregional recurrence-are expected by the end of 2013. Ethicon Endo-Surgery Europe, Swedish Cancer Foundation, West Gothia Region, Sahlgrenska University Hospital. Copyright © 2013 Elsevier Ltd. All rights reserved.
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                Author and article information

                Contributors
                hoshinob@kuhp.kyoto-u.ac.jp
                Journal
                Ann Gastroenterol Surg
                Ann Gastroenterol Surg
                10.1002/(ISSN)2475-0328
                AGS3
                Annals of Gastroenterological Surgery
                John Wiley and Sons Inc. (Hoboken )
                2475-0328
                21 November 2020
                March 2021
                : 5
                : 2 ( doiID: 10.1002/ags3.v5.2 )
                : 183-193
                Affiliations
                [ 1 ] Department of Surgery Kyoto University Graduate School of Medicine Kyoto Japan
                Author notes
                [*] [* ] Correspondence

                Nobuaki Hoshino, Department of Surgery, Kyoto University Graduate School of Medicine, 54 Shogoin‐Kawahara‐cho, Sakyo‐ku, Kyoto 606‐8507, Japan

                Email: hoshinob@ 123456kuhp.kyoto-u.ac.jp

                Author information
                https://orcid.org/0000-0002-7171-8971
                Article
                AGS312409
                10.1002/ags3.12409
                8034685
                33860138
                2f690a5d-1e71-4598-b640-49b9d812c136
                © 2020 The Authors. Annals of Gastroenterological Surgery published by John Wiley & Sons Australia, Ltd on behalf of The Japanese Society of Gastroenterology

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                : 17 October 2020
                : 30 August 2020
                : 26 October 2020
                Page count
                Figures: 4, Tables: 2, Pages: 11, Words: 7254
                Funding
                Funded by: Kondou Kinen Medical Foundation , open-funder-registry 10.13039/501100008658;
                Categories
                Systematic Review Article
                Systematic Review Article
                Custom metadata
                2.0
                March 2021
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.0.1 mode:remove_FC converted:09.04.2021

                case‐matched study,low anterior resection,randomized controlled trial,rectal cancer

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