Postoperative GI Dysfunction and Nutrition in Malnourished Cancer Surgery Patients

The proportion of participants whose gastrointestinal dysfunction regresses to a Lausanne Intestinal Failure Estimation (LIFE) score of ≤1 within the assessment window (POD4-POD6). LIFE is assessed once daily from POD1 through POD7 using routine clinical parameters.

Average of daily LIFE scores measured once per day from POD1 to POD7. LIFE is a composite clinical score of gastrointestinal dysfunction. Mean LIFE over this period will be compared between serotonin exposed and non exposed cohorts to describe the trajectory of GI function.

Number of days from surgery to the first documented spontaneous bowel movement without clinically significant ongoing gastrointestinal dysfunction (as judged by the treating team and LIFE score).

Proportion of participants with at least one positive delirium assessment using CAM ICU or ICDSC during ICU and ward stay.

Total number of calendar days with positive CAM-ICU or ICDSC assessments.

Proportion of participants who develop at least one postoperative complication of Clavien-Dindo grade II or higher; separate reporting of grade III-V complications.

Proportion of participants with clinically diagnosed infectious complications (e.g., surgical site infection, pneumonia, intra abdominal abscess, sepsis) during the index hospitalization.

Number of days spent

• in the ICU during the index postoperative stay
• in the hospital for the index surgical admission.

Proportion of participants who die

• before discharge from the index hospitalization
• within 30 days after surgery, based on hospital records and, where available, follow up information.

Incidence of cardiovascular, hematologic, metabolic, and neuropsychiatric adverse events with emphasis on thrombotic events, serious arrhythmias, severe hypertensive reactions, and events compatible with serotonin syndrome

Difference in body weight (kg) between baseline and discharge.

Difference in mid upper arm circumference (cm) as a simple anthropometric marker of muscle mass.

Difference in FFM (kg) between baseline and postoperative day 6-10 (or discharge). For participants in whom bioelectrical impedance analysis (BIA) is performed as part of extended clinical assessment.

Difference in SMM (kg) between baseline and postoperative day 6-10 (or discharge). For participants in whom bioelectrical impedance analysis (BIA) is performed as part of extended clinical assessment.

Difference in SMMI (kg/m²) between baseline and postoperative day 6-10 (or discharge). For participants in whom bioelectrical impedance analysis (BIA) is performed as part of extended clinical assessment.

Difference in phase angle (degrees) between baseline and postoperative day 6-10 (or discharge).For participants in whom bioelectrical impedance analysis (BIA) is performed as part of extended clinical assessment.

Difference in Nutritional Risk Screening 2002 (NRS-2002) total score between baseline (preoperative assessment) and the day of hospital discharge. The NRS-2002 total score ranges from 0 to 7; higher scores indicate greater nutritional risk. For reporting, present mean (SD) change and number (%) of participants with clinically relevant change (e.g., change ≥1 point).

Change in malnutrition severity category as defined by the Global Leadership Initiative on Malnutrition (GLIM) criteria between the preoperative baseline assessment and the day of hospital discharge. GLIM categories to be reported: No malnutrition, Moderate malnutrition, Severe malnutrition. For results reporting, present the number and proportion of participants in each GLIM category at baseline and at discharge, and the number and proportion of participants with a change in category (e.g., Moderate → Severe, Severe → Moderate, Any worsening, Any improvement).

Difference in Patient-Generated Subjective Global Assessment (PG-SGA) total score between baseline (preoperative assessment) and the day of hospital discharge. PG-SGA is a validated nutritional assessment instrument; higher total scores indicate worse nutritional status. For results reporting, present mean (SD) change and median (IQR), and report the number and proportion of participants with a clinically meaningful change (predefined in the SAP; e.g., change ≥2 points).

Number of days from initiation of postoperative nutritional support to the first day on which ≥60-70% of calculated daily energy requirements are delivered via the enteral route, sustained according to local practice. Calculated energy targets follow institutional nutritional protocols (typically ~25-30 kcal/kg/day).