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.
Background Colorectal cancer (CRC) is the third most frequent cause of cancer death in the word. Which aspects of research into CRC should be accorded the highest priority remains unclear, because relevant stakeholders, such as patients, nurses, and physicians, played hardly any part in the development of research projects. The goal in forming the CRC Priority-Setting Partnership (PSP) was to bring all relevant stakeholders together to identify and prioritize unresolved research questions regarding the diagnosis, treatment, and follow-up of CRC. Methods The CRC PSP worked in cooperation with the British James Lind Alliance. An initial nationwide survey was conducted, and evidence uncertainties were collected, categorized, summarized, and compared with available evidence from the literature. The as-yet unresolved questions were (provisionally) ranked in a second national wide survey, and at a concluding consensus workshop all stakeholders came together to finalize the rankings in a nominal group process and compile a top 10 list. Results In the first survey (34% patients, 51% healthcare professionals, 15% unknown), 1102 submissions were made. After exclusion of duplicates and previously resolved questions, 66 topics were then ranked in the second survey (56% patients, 39% healthcare professionals, 5% unknown). This interim ranking process revealed distinct differences between relatives and healthcare professionals. The final top 10 list compiled at the consensus workshop covers a wide area of research topics. Conclusion All relevant stakeholders in the CRC PSP worked together to identify and prioritize the top 10 evidence uncertainties. The results give researchers and funding bodies the opportunity to address the most patient-relevant research projects. It is the first detailed description of a PSP in Germany, and the first PSP on CRC care worldwide.
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