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.

Methodological index for non-randomized studies (minors): development and validation of a new instrument.

https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(05)66545-2.pdf

Short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer (MRC CLASICC trial): multicentre, randomised controlled trial

This is the fourth updated Enhanced Recovery After Surgery (ERAS®) Society guideline presenting a consensus for optimal perioperative care in colorectal surgery and providing graded recommendations for each ERAS item within the ERAS® protocol. A wide database search on English literature publications was performed. Studies on each item within the protocol were selected with particular attention paid to meta-analyses, randomised controlled trials and large prospective cohorts and examined, reviewed and graded according to Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system. All recommendations on ERAS® protocol items are based on best available evidence; good-quality trials; meta-analyses of good-quality trials; or large cohort studies. The level of evidence for the use of each item is presented accordingly. The evidence base and recommendation for items within the multimodal perioperative care pathway are presented by the ERAS® Society in this comprehensive consensus review.

/pdf/guidelines-for-perioperative-care-in-elective-colonic-1wl593eui2.pdf

Guidelines for perioperative care in elective colonic surgery: Enhanced recovery after surgery (ERAS®) society recommendations

Riedel DJ, Gonzalez-Cuyar LF, Zhao XF, Redfi eld RR, Gilliam BL. Plasmablastic lymphoma of the oral cavity: a rapidly progressive lymphoma associated with HIV infection. Lancet Infect Dis 2008; 8: 261–67. In this Grand Round, the references for the sentence “Occasionally, CD138-negative plasmablastic lymphoma cases (such as this case) have been reported” (page 265) should be 32, 34, and 38. Book Systematic reviews: CRD’s guidance for undertaking reviews in health care

/pdf/systematic-reviews-crd-s-guidance-for-undertaking-reviews-in-4hcrkbrbv4.pdf

Systematic reviews: CRD's guidance for undertaking reviews in health care

Risk factors of critical & mortal COVID-19 cases: A systematic literature review and meta-analysis.

Background:Earlier meta-analyses of small randomized trials suggested that mechanical bowel preparation (MBP) should be omitted before colorectal surgery because it does not affect complication rates 0 mortality and may be even harmful; however, more recent large randomized trials suggested an incre

Updated systematic review and meta-analysis of randomized clinical trials on the role of mechanical bowel preparation before colorectal surgery

Mechanical bowel preparation is used routinely before colorectal surgery, but some randomized clinical trials have suggested that it is of no benefit. This study assesses whether such bowel preparation may safely be omitted before elective colorectal surgery. A search of the literature was performed; the inclusion criteria were randomized clinical trials comparing bowel preparation with no preparation in colorectal surgery. The methodological quality of included trials was assessed. The primary outcome was anastomotic leakage; secondary outcomes were other septic complications. The meta-analysis was conducted using the Peto one-step method. Eleven trials were retrieved, of which seven, containing 1454 patients, were included in the meta-analysis. There was no heterogeneity between the trials. Significantly more anastomotic leakage was found after mechanical bowel preparation (5.6 versus 3.2 per cent; odds ratio 1.75 (95 per cent confidence interval 1.05 to 2.90); P = 0.032). All other endpoints (wound infection, other septic complications and non-septic complications) also favoured the no-preparation regimen, but the differences were not statistically significant. Sensitivity analysis showed that these results were similar when trials of poor quality were excluded. Subgroup analysis showed that anastomotic leakage was significantly greater after bowel preparation with polyethylene glycol (PEG) compared with no preparation, but not after other types of preparation. There is good evidence to suggest that mechanical bowel preparation using PEG should be omitted before elective colorectal surgery. Other bowel preparations should be evaluated by further large randomized trials.

/pdf/meta-analysis-of-randomized-clinical-trials-of-colorectal-3twtqm7l57.pdf

Meta-analysis of randomized clinical trials of colorectal surgery with or without mechanical bowel preparation.

Objective: To assess with a single-blinded, multicenter, randomized trial, the postoperative results in patients undergoing sphincter-saving rectal resection for cancer without preoperative mechanical bowel preparation (MBP). Background: The collective evidence from literature strongly suggests that MBP, before elective colonic surgery, is of no benefit in terms of postoperative morbidity. Very few data and no randomized study are available for rectal surgery and preliminary results conclude toward the safety of rectal resection without MBP. Methods: From October 2007 to January 2009, patients scheduled for elective rectal cancer sphincter-saving resection were randomized to receive preoperative MBP (ie, retrograde enema and oral laxatives) or not. Primary endpoint was the overall 30-day morbidity rate. Secondary endpoints included mortality rate, anastomotic leakage rate, major morbidity rate (Dindo III or more), degree of discomfort for the patient, and hospital stay. Results: A total of 178 patients (103 men), including 89 in both groups (no-MBP and MBP groups), were included in the study. The overall and infectious morbidity rates were significantly higher in no-MBP versus MBP group, 44% versus 27%, P = 0.018, and 34% versus 16%, P = 0.005, respectively. Regarding both anastomotic leakage and major morbidity rates, there was no significant difference between no-MBP and MBP group: 19% versus 10% (P = 0.09) and 18% versus 11% (P = 0.69), respectively. Moderate or severe discomfort was reported by 40% of prepared patients. Mortality rate (1.1% vs 3.4%) and mean hospital stay (16 vs 14 days) did not differ significantly between both groups. Conclusions: This first randomized trial demonstrated that rectal cancer surgery without MBP was associated with higher risk of overall and infectious morbidity rates without any significant increase of anastomotic leakage rate. Thus, it suggests continuing to perform MBP before elective rectal resection for cancer. This study is registered with ClinicalTrials.gov, number NCT00554892.

https://www.espoire.org/wp-content/uploads/2011/07/Prep-col-rectum-Ann-Surg-20101.pdf

Rectal cancer surgery with or without bowel preparation: The French GRECCAR III multicenter single-blinded randomized trial.

Objectif, - L 'index de qualite de vie pour les maladies digestives (GIQLI) est un questionnaire developpe en Allemagne. Le but de cette etude etait d'en valider la version francaise. Methodes. - Le questionnaire comporte 36 items explorant les symptomes, la condition physique, les emotions, l'integration sociale, et l'effet du traitement medical, Il a ete propose a 615 personnes. 335 sujets sains et 280 malades. L'acceptabilite du questionnaire et les scores absolu et relatif etaient calcules dans les 2 groupes. La validation psychometrique etait faite par l'etude de la pertinence du regroupement des items (validites convergente et discriminante) et la fiabilite du questionnaire (coherence interne). Resultats. - L'acceptabilite etait de 93 %. Le score absolu moven etait de 126 (sur 144) pour les sujets sains et 96 pour les malades (P < 0.00001). La pertinence du regroupement des items, la fiabilite etaient demontrees et la validite clinique suggeree dans ce groupe de malades. Conclusion. - Cette etude a permis la validation psychometrique de la version francaise du GIQLI, Ce questionnaire pourrait etre utilise en France comme un moyen de mesure fiable de la qualite de vie en pathologie digestive.

Jacques Chipponi

Papers

Methodological index for non-randomized studies (minors): development and validation of a new instrument.

Updated systematic review and meta-analysis of randomized clinical trials on the role of mechanical bowel preparation before colorectal surgery

Meta-analysis of randomized clinical trials of colorectal surgery with or without mechanical bowel preparation.

Rectal cancer surgery with or without bowel preparation: The French GRECCAR III multicenter single-blinded randomized trial.

First validation of the French version of the Gastrointestinal Quality of Life Index (GIQLI)