DOI: 10.6084/m9.figshare.31211734
title: Data of ERAS QC study

description: 1.1 Study Design This was a prospective, randomized controlled study. 1.2 Participants A total of 139 patients with advanced gastric cancer (including Siewert type II and III adenocarcinoma of the esophagogastric junction, AEG) scheduled for surgery in the Department of General Surgery of our hospital from January 2022 to October 2023 were prospectively enrolled. All surgical and anesthetic procedures were performed by the same surgical team. 1.3 Inclusion and Exclusion Criteria Inclusion criteria: ① Age 18-80 years; ② Scheduled for subtotal or total gastrectomy for advanced gastric cancer (including AEG); ③ No preoperative signs of gastrointestinal obstruction; ④ Planned for perioperative management according to the ERAS pathway; ⑤ Complete medical records. Exclusion criteria: ① Concurrent other malignancies; ② Combined resection of other organs during the same operation; ③ Incomplete medical records; ④ Emergency surgery. 1.4 Ethical Considerations This study was approved by the hospital's ethics committee, and written informed consent was obtained from all patients. 1.5 Intervention and Procedures A multidisciplinary expert team of 30 members was established, comprising gastrointestinal surgeons, anesthesiologists, nutritionists, and nursing staff from both our institution and external units. Selection criteria: ① Having completed standardized ERAS training and passed assessment; ② Clinical experience ≥5 years, ERAS implementation experience ≥3 years; ③ Intermediate or higher professional title; ④ High motivation for this study, able to provide constructive suggestions from different perspectives, and available for consultation and discussion throughout the study period. A modified Delphi method involving three rounds of consultation and discussion was employed. With reference to evidence-based literature such as the "Chinese Clinical Practice Guidelines for Enhanced Recovery After Surgery (2021)", a quality control standard encompassing 20 perioperative measures was formulated. To objectively reflect the relative importance and contribution of each measure to overall quality control and postoperative recovery, the expert team independently stratified, evaluated, and ranked each measure using the Analytic Hierarchy Process (AHP). Specific weight coefficients for each item were calculated, and six core measures were identified (shortened preoperative fasting, anesthesia technique, minimally invasive technique, fluid management, pain management, and early postoperative ambulation). Based on this, a Quality Control Scoring Sheet was developed. All enrolled patients were randomly divided into two groups using a random number table. Both groups received perioperative management from clinical care teams trained in the standardized ERAS protocol. The intervention group additionally received management guided by the aforementioned 20-item quantitative QC standards (based on the detailed scoring sheet), with real-time feedback and corrections according to these standards. The control group received conventional ERAS pathway management without the structured QC system intervention. Throughout the trial, dedicated research personnel used the validated QC Scoring Sheet to record the implementation status of all ERAS measures for all patients. This scoring sheet underwent rigorous reliability and validity testing prior to the formal study. 1.6 ERAS Measures Quality Control Scoring Sheet No. Item Scoring/Level (①0, ②25, ③50, ④75, ⑤100 points) Weight Coefficient 1 Nutritional Assessment and Support ① Not implemented ② Only nutritional screening completed ③ Nutritional assessment + basic nutritional education ④ Nutritional assessment + nutritional support ⑤ Dynamic nutritional assessment throughout + nutritional support 0.043 2 Alcohol Cessation ① Not abstained ② &lt;1 week ③ 1–2 weeks ④ 2–3 weeks ⑤ 3–4 weeks 0.029 3 Smoking Cessation ① Not quit ② &lt;1 week ③ 1–2 weeks ④ 2–3 weeks ⑤ ≥3 weeks 0.033 4 Cardiopulmonary Function Assessment + Prehabilitation ① Basic screening ② Basic screening + simple exercise tolerance or cardiopulmonary function assessment ③ Risk stratification based on assessment results ④ Individualized prehabilitation plan initiated based on risk stratification ⑤ Prehabilitation plan implemented for &gt;1 week with expected goals achieved 0.048 5 Preoperative Correction of Anemia ① Hb &lt;70 g/L and not managed ② Hb 70–79 g/L ③ Hb 80–89 g/L ④ Hb 90–100 g/L ⑤ Hb &gt;100 g/ 0.049 6 Mental and Psychological Status Assessment ① Not performed ② Simple inquiry ③ Standardized scale assessment (e.g., HADS) ④ Anxiety/depression risk identified, simple education provided ⑤ Psychological or pharmacological intervention plan developed and implemented for medium- to high-risk patients 0.040 7 Thrombosis Risk Assessment and Prevention ① Not assessed ② Assessment completed but prevention not initiated ③ Assessment completed + basic prevention (e.g., compression stockings) ④ Standard pharmacological prevention after assessment ⑤ Individualized combined prevention after assessment 0.049 8 Shortened Preoperative Fasting (Core) ① Traditional fasting (solid &gt;8 h, clear liquid &gt;6 h) ② Clear liquids allowed until 4 h before surgery ③ Clear liquids allowed until 2 h before surgery ④ Oral carbohydrates 10 h before surgery + clear liquid until 2 h before surgery ⑤ Individualized fasting protocol, oral carbohydrates until 2 h before surgery 0.062 9 Preoperative Oral Carbohydrates ① Not performed ② Only 800 ml 10% glucose solution the night before surgery ③ Only 800 ml 12.5% carbohydrate solution the night before surgery ④ 800 ml the night before + ≤400 ml 10% glucose solution 2 h before surgery ⑤ 800 ml the night before + ≤400 ml 12.5% carbohydrate solution 2 h before surgery 0.049 10 Prophylactic Antibiotics ① Not administered ② Administered but inappropriate type or timing ③ Correct type but inappropriate dose or timing ④ Correct type and dose but inappropriate timing ⑤ Correct type, dose, and timing 0.052 11 Anesthesia Technique (Core) ① Conventional general anesthesia ② General anesthesia with BIS monitoring ③ General anesthesia with BIS monitoring + short-acting anesthetics ④ General anesthesia with BIS monitoring + transversus abdominis plane block ⑤ General anesthesia with BIS monitoring + mid-thoracic epidural anesthesia 0.063 12 Minimally Invasive Technique (Core) ① Traditional open surgery ② Planned laparoscopic/robotic surgery converted to open ③ Laparoscopic/robotic surgery, duration &gt;4 h ④ Laparoscopic/robotic surgery, duration ≤4 h ⑤ Laparoscopic/robotic surgery, duration ≤3 h 0.067 13 Intraoperative Fluid Management (Core) ① Fluid volume &gt;2500 ml or significantly positive balance ② Fluid volume 2000–2500 ml ③ Fluid volume ≈ urine output and &lt;2000 ml ④ Goal-directed fluid therapy (GDFT) implemented but with hemodynamic fluctuations ⑤ GDFT implemented throughout with stable hemodynamics 0.064 14 Intraoperative Temperature Management ① No warming ② Only passive warming (e.g., room temperature, blankets) ③ One active warming measure used (e.g., forced-air warmer) ④ ≥2 active warming measures used ⑤ Active warming throughout with monitoring, no hypothermia (&gt;36°C) postoperatively 0.043 15 Nasogastric Tube Management ① Removed &gt;72 h ② Removed 48–72 h ③ Removed 24–48 h ④ Removed &lt;24 h ⑤ Not placed or removed intraoperative 0.044 16 Abdominal Drain Placement ① Removed &gt;7 days ② Removed 5–7 days ③ Removed 3–5 days ④ Removed &lt;3 days ⑤ Not placed 0.045 17 Postoperative Pain Management (Core) ① On-demand analgesia ② One scheduled analgesia regimen ③ Two combined modes of analgesia ④ Three combined modes of analgesia ⑤ Multimodal analgesia with individualized adjustment 0.065 18 Early Postoperative Oral Intake ① Initiated after flatus ② Liquid diet &gt;48 h postoperatively ③ Liquid diet 24–48 h postoperatively ④ Liquid diet ≤24 h postoperatively ⑤ Clear liquid attempted at 6 h postoperatively, rapid progression thereafter 0.051 19 Early Postoperative Ambulation (Core) ① No ambulation within 24 h ② Ambulation &lt;10 min/day within 24 h ③ Ambulation 10–30 min/day within 24 h ④ Ambulation &gt;30 min/day within 24 h ⑤ Ambulation started at 6 h postoperatively, gradually increased daily 0.062 20 Urinary Catheter Management ① Removed &gt;72 h ② Removed 48–72 h ③ Removed 24–48 h ④ Removed &lt;24 h ⑤ Not placed or removed intraoperatively 0.042 2.7 Collected data included: l Baseline data: Age, gender, BMI, Age-adjusted Charlson Comorbidity Index (ACCI), ASA physical status classification, NRS2002 nutritional risk screening score (on admission), preoperative hemoglobin (HB), preoperative serum albumin (ALB). l Perioperative data: Surgical quality (including operative time, intraoperative blood loss, tumor location, tumor size, resection margin, number of lymph nodes harvested, number of positive lymph nodes, etc.), anesthesia technique, postoperative pain management (NRS score and opioid use), time to first postoperative oral intake, time to first postoperative ambulation, time to removal of various catheters/drains, number of unplanned events and number handled within 2 hours, postoperative complications (Clavien-Dindo grade ≥II). Note: Unplanned events refer to issues identified during the pathway that are easily overlooked but require timely resolution; prompt management of such events can reduce complication rates. Common unplanned events included failure to assess and implement interventions as required by the clinical pathway schedule, or delayed intervention for patient symptoms such as dizziness, nausea, vomiting, insomnia, poor blood pressure/glucose control, drain dislodgement, etc. l Number of ERAS measures implemented, scores for each item, total score, and phase-specific scores (preoperative, intraoperative, postoperative). l Primary outcome: Postoperative length of stay (LOS). l Secondary outcomes: Unplanned reoperation and readmission.