Preoperative Risk Evaluation for Cancer Treatment (PREdiCT): protocol for an international cohort study evaluating a...

Gastrointestinal cancer surgery commonly leads to postoperative complications and other adverse outcomes. While prehabilitation shows promise in reducing adverse postoperative outcomes, most hospitals have resource limitations that preclude its use as standard of care. Additionally, the need to expedite surgery from diagnosis often creates a narrow window for prehabilitation initiatives. Online, self-reported screening tools may address these challenges by facilitating early identification of high-risk patients and enabling targeted preoperative interventions, thereby allowing equitable allocation of limited resources. Therefore, the primary aim of this study is to evaluate the predictive utility of a tri-modal (physical, nutritional, psychological) screening tool for patients undergoing gastrointestinal cancer surgery.

This prospective international cohort study will recruit 1214 adults undergoing elective gastrointestinal cancer surgery across 35 sites from 19 countries. Participants will complete an online screening tool developed through a comprehensive, multistep, predefined process. The screening tool comprises the Duke Activity Status Index, Patient-Generated Subjective Global Assessment Short Form and the Patient Health Questionnaire-4, in English, Spanish, French or Portuguese. These tools were selected based on a scoping review, followed by an international Delphi consensus process. The primary outcomes include rate of postoperative complications, major complications (Clavien-Dindo Classification grade III-V) and overall complication severity assessed by the Comprehensive Complications Index; all assessed 30 days postoperatively. Secondary outcomes include hospital length of stay, readmission rate within 30 days, discharge destination (home vs other), days at home and alive in 30 days postsurgery, 30-day all-cause mortality and 12-month survival. Primary analyses will establish optimal screening tool cut-points to stratify patients into clinically actionable risk categories for postoperative complications and examine the independent predictive value of these screening scores after adjusting for established clinical risk factors.

This study has received ethical approval from the Sydney Local Health District Human Research and Ethics Committee (X25-0333 and 2025/ETH02465) and has been registered on the Open Science Framework (10.17605/OSF.IO/HVCGD). The results of Preoperative Risk Evaluation for Cancer Treatment will be submitted to reputable journals and presented at national and international conferences.