A framework for Surgical Quality Assurance (SQA) in randomized controlled trials in gastrointestinal surgery: an international Delphi consensus study

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Background: Randomized controlled trials (RCTs) in gastrointestinal surgery often lack standardized approaches to Surgical Quality Assurance (SQA), which threatens both internal and external validity. The technical complexity and inherent inter-surgeon variability in gastrointestinal procedures pose significant challenges for standardizing interventions and ensuring reproducible outcomes. SQA involves credentialing of surgeons, standardization of surgical techniques, and monitoring of performance, but consensus on essential components has been missing. To address this gap, we conducted a four-round Delphi consensus process with 40 international experts in gastrointestinal surgery and clinical trials. Methods: Experts from 15 countries were invited to rate the relevance of potential SQA items using a 5-point Likert scale from December 2023 to December 2024. The checklist was structured into three domains: credentialing, standardization of surgical techniques, and performance monitoring. Items rated as 4 ('important') or 5 ('very important') by at least 80% of experts were included in the final SQA checklist. Findings: Consensus was reached on 13 essential SQA items including a minimum annual case volume per center, a minimum surgeon case volume (overall and annually), standardized reporting guidelines, pretrial education (written materials and videos), standardization of surgical approach, standardized extent of lymphadenectomy, proctoring surgeons (without and with limited experience), periodic pathological assessment, and performance monitoring through Case Report Forms or patient file data. Interpretation: This Delphi study establishes an international expert consensus framework of 13 items for Surgical Quality Assurance in RCTs in gastrointestinal surgery. This framework is expected to be widely utilized to enhance the quality of surgical trials by improving the internal and external validity. Adoption of these standards may help strengthen the credibility, comparability, and clinical relevance of future surgical RCTs. Funding: This study received no funding.

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