Background: Because of specific methodological difficulties in conducting randomized trials, surgical research remains dependent predominantly on observational or non-randomized studies. Few validated instruments are available to determine the methodological quality of such studies either from the reader's perspective or for the purpose of meta-analysis. The aim of the present study was to develop and validate such an instrument. Methods: After an initial conceptualization phase of a methodological index for non-randomized studies (MINORS), a list of 12 potential items was sent to 100 experts from different surgical specialities for evaluation and was also assessed by 10 clinical methodologists. Subsequent testing involved the assessment of inter-reviewer agreement, test-retest reliability at 2 months, internal consistency reliability and external validity. Results:The final version of MINORS contained 12 items, the first eight being specifically for non-comparative studies. Reliability was established on the basis of good inter-reviewer agreement, high test-retest reliability by the κ -coefficient and good internal consistency by a high Cronbach's α -coefficient. External validity was established in terms of the ability of MINORS to identify excellent trials. Conclusions: MINORS is a valid instrument designed to assess the methodological quality of non-randomized surgical studies, whether comparative or non-comparative. The next step will be to determine its external validity when used in a large number of studies and to compare it with other existing instruments.Key words: comparative study, methodology index, non-randomized study.Abbreviation : MINORS, methodological index for non-randomized studies. INTRODUCTIONAlthough surgeons are now conducting an increasing number of randomized trials, 1 most of the available evidence in surgery comes from non-randomized studies, both comparative and noncomparative. Indeed surgical research remains an example of a situation where randomization is not always possible or feasible. 2 Beyond large randomized trials, systematic reviews are an important way to answer questions in surgery. However, the systematic review or meta-analysis of studies other than randomized trials may be difficult because combining the results of observational studies of heterogeneous quality could be highly biased.Observational studies include comparative studies such as case-control and cohort designs, and patient series which may or may not involve comparisons between two or more groups.Several papers have discussed the methodology of metaanalyses of observational studies 3,4 and checklists have been proposed but not formally validated. 5 Downs and Black used clinimetric criteria to develop a checklist which was applicable to both randomized and non-randomized studies without distinction. 6 The aim of the present study was to develop and validate a methodological index for non-randomized studies (MINORS) which could be used by readers, manuscript reviewers or journal editors to assess the quality...

Purpose A pathologic complete response (pCR; ypT0N0) of a rectal tumor after neoadjuvant radiochemotherapy (RCT) is associated with an excellent prognosis. Several retrospective studies have investigated the effect of increasing the delay after RCT. The aim of this study was to evaluate the effect of increasing the interval between the end of RCT and surgery on the pCR rate. Methods GRECCAR6 was a phase III, multicenter, randomized, open-label, parallel-group controlled trial. Patients with cT3/T4 or Tx N+ tumors of the mid or lower rectum who had received RCT (45 to 50 Gy with fluorouracil or capecitabine) were included. Patients were randomly included in the 7-week or the 11-week (11w) group. Primary end point was the pCR rate defined as a ypT0N0 specimen (NCT01648894). Results A total of 265 patients from 24 centers were enrolled between October 2012 and February 2015. The majority of the tumors were cT3 (82%). After RCT, surgery was not performed in nine patients (3.4%) because of the occurrence of distant metastasis (n = 5) or other reasons. Two patients underwent local resection of the tumor scar. A total of 47 (18.6%) specimens were classified as ypT0 (four had invaded lymph nodes [8.5%]). The primary end point (ypT0N0) was not different (7 weeks: 20 of 133, 15.0% v 11w: 23 of 132, 17.4%; P = .5983). Morbidity was significantly increased in the 11w group (44.5% v 32%; P = .0404) as a result of increased medical complications (32.8% v 19.2%; P = .0137). The 11w group had a worse quality of mesorectal resection (complete mesorectum [I] 78.7% v 90%; P = .0156). Conclusion Waiting 11 weeks after RCT did not increase the rate of pCR after surgical resection. A longer waiting period may be associated with higher morbidity and more difficult surgical resection.

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Recurrent clinical episode of Crohn's disease, preoperative steroids use, poor nutritional status, and the presence of abscess at the time of surgery significantly increased the risk of septic abdominal complications after first ileocecal resection for Crohn's disease. Knowledge of these risk factors could permit to propose a temporary stoma in very high-risk patients (i.e., with 3 or more risk factors).

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