Background An intestinal ostomy is an artificial bowel opening created on the skin. Procedure-related mortality is extremely rare. However, the presence of an ostomy may be associated with significant morbidity. Complications negatively affect the quality of life of ostomates. Preoperative stoma site marking can reduce stoma-related complications and is recommended by several guidelines. However, there is no consensus on the procedure and recommendations are based on low-quality evidence. The objective of the systematic review will be to investigate if preoperative stoma site marking compared to no preoperative marking in patients undergoing intestinal stoma surgery reduces or prevents the rate of stoma-related complications. Methods We will include (cluster-) randomised controlled trials and cohort studies that involve patients with intestinal ostomies comparing preoperative stoma site marking to no preoperative marking and report at least one patient-relevant outcome. For study identification, we will systematically search MEDLINE/PubMed, EMBASE, CENTRAL and CINHAL as well as Google Scholar, trial registries, conference proceedings and reference lists. Additionally, we will contact experts in the field. Two reviewers will independently perform study selection and data extraction. Outcomes will be prioritised based on findings from telephone interviews with five ostomates and five ostomy and wound nurses prior to conducting the review. Outcomes may include but are not limited to stoma-related complications (infection, parastomal abscess, hernia, mucocutaneous separation, dermatological complications, stoma necrosis, stenosis, retraction and prolapse) or other patient-relevant postoperative endpoints (quality of life, revision rate, dependence on professional care, mortality, length of stay and readmission). We will use the ROBINS-I or the Cochrane risk of bias tool to assess the risk of bias of the included studies. We will perform a meta-analysis and assess the certainty of evidence using the GRADE approach. Discussion With the results of the systematic review, we aim to provide information for future clinical guidelines and influence clinical routine with regard to preoperative stoma site marking in patients undergoing ostomy surgery. When the evidence of our systematic review is low, it would still be a useful basis for future clinical trials by identifying data gaps. Systematic review registration PROSPERO registration number: CRD42021226647

Aim This systematic review and meta‐analysis aimed to investigate the effect of preoperative stoma site marking on stoma‐related complications in patients with intestinal ostomy. Methods MEDLINE, Embase, CENTRAL, CINHAL, and Google Scholar were searched up to August 2021 for randomised controlled trials (RCTs) and nonrandomised studies of interventions (NRSI) that involved patients with intestinal ostomies comparing preoperative stoma site marking to no marking and which reported at least one patient‐relevant outcome. Outcomes were prioritised by stakeholder involvement. Random‐effects meta‐analyses produced odds ratios (ORs) or standardised mean differences (SMD) and 95% confidence intervals (CIs). The ROBINS‐I tool and the GRADE approach were used to assess the risk of bias and certainty of evidence, respectively. Results This review included two RCTs and 25 NRSI. The risk of bias was high in RCTs and serious to critical in NRSI. Although preoperative site marking reduced stoma‐related complications (OR: 0.45, 95% CI: [0.31–0.65]), dependence on professional or unprofessional care (narrative synthesis), and increased health‐related quality of life (SMD: 1.13 [0.38–1.88]), the evidence is very uncertain. Preoperative site marking may probably reduce leakage (OR: 0.14 [0.06–0.37]) and may decrease dermatological complications (OR: 0.38 [0.29–0.50]) and surgical revision (OR: 0.09 [0.02–0.49]). The confidence in the cumulative evidence was moderate to very low. Conclusion Despite low quality evidence, preoperative stoma site marking can prevent stoma‐related complications and should be performed in patients undergoing gastrointestinal surgery given that this intervention poses no harm to patients.

Purpose This systematic review and dose–response meta-analysis aimed to investigate the relationship between hospital volume and outcomes for total knee arthroplasty (TKA). Methods MEDLINE, Embase, CENTRAL and CINAHL were searched up to February 2020 for randomised controlled trials and cohort studies that reported TKA performed in hospitals with at least two different volumes and any associated patient-relevant outcomes. The adjusted effect estimates (odds ratios, OR) were pooled using a random-effects, linear dose–response meta-analysis. Heterogeneity was quantified using the I2-statistic. ROBINS-I and the GRADE approach were used to assess the risk of bias and the confidence in the cumulative evidence, respectively. Results A total of 68 cohort studies with data from 1985 to 2018 were included. The risk of bias for all outcomes ranged from moderate to critical. Higher hospital volume may be associated with a lower rate of early revision ≤ 12 months (narrative synthesis of k = 7 studies, n = 301,378 patients) and is likely associated with lower mortality ≤ 3 months (OR = 0.91 per additional 50 TKAs/year, 95% confidence interval [0.87–0.95], k = 9, n = 2,638,996, I2 = 51%) and readmissions ≤ 3 months (OR = 0.98 [0.97–0.99], k = 3, n = 830,381, I2 = 44%). Hospital volume may not be associated with the rates of deep infections within 1–4 years, late revision (1–10 years) or adverse events ≤ 3 months. The confidence in the cumulative evidence was moderate for mortality and readmission rates; low for early revision rates; and very low for deep infection, late revision and adverse event rates. Conclusion An inverse volume–outcome relationship probably exists for some TKA outcomes, including mortality and readmissions, and may exist for early revisions. Small reductions in unfavourable outcomes may be clinically relevant at the population level, supporting centralisation of TKA to high-volume hospitals. Level of evidence III. Registration number The study was registered in the International Prospective Register of Systematic Reviews (PROSPERO CRD42019131209 available at: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=131209).

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Background Total knee arthroplasty (TKA) is performed to treat end-stage knee osteoarthritis. In Germany, a minimum volume threshold of 50 TKAs/hospital/year was implemented to ensure outcome quality. This study, embedded within a systematic review, aimed to investigate the perspectives of potential TKA patients on the hospital volume-outcome relationship for TKA (higher volumes associated with better outcomes). Methods A convenience sample of adults with knee problems and heterogeneous demographic characteristics participated in the study. Qualitative data were collected during a focus group prior to the systematic review (n = 5) and during telephone interviews, in which preliminary results of the systematic review were discussed (n = 16). The data were synthesised using content analysis. Results All participants (n = 21) believed that a hospital volume-outcome relationship exists for TKA while recognising that patient behaviour or the surgeon could also influence outcomes. All participants would be willing to travel longer for better outcomes. Most interviewees would choose a hospital for TKA depending on reputation, recommendations, and service quality. However, some would also choose a hospital based on the results of the systematic review that showed slightly lower mortality/revision rates at higher-volume hospitals. Half of the interviewees supported raising the minimum volume threshold even if this were to increase travel time to receive TKA. Conclusions Potential patients believe that a hospital volume-outcome relationship exists for TKA. Hospital preference is based mainly on subjective factors, although some potential patients would consider scientific evidence when making their choice. Policy makers and physicians should consider the patient perspectives when deciding on minimum volume thresholds or recommending hospitals for TKA, respectively.