This is a prospective two-center observational cohort study in adult patients undergoing major abdominal and/or pelvic oncologic surgery with pre-existing malnutrition. The study describes the course of postoperative gastrointestinal dysfunction and evaluates whether real-world exposure to parenteral serotonin as part of routine postoperative care is associated with a higher proportion of patients whose gastrointestinal dysfunction regresses to LIFE score less than or equal to 1 by postoperative day 5 (plus or minus 1 day), compared with patients not exposed to serotonin.
All treatment decisions, including the use of parenteral serotonin, metoclopramide, neostigmine, nutritional support, and other postoperative management, are made solely by the treating physicians in accordance with routine clinical practice. The protocol does not assign, randomize, require, or restrict any drug treatment; it records real-world care, daily LIFE assessments during postoperative days 1 through 7, nutritional status measures, body composition where available, delirium screening, complications, length of stay, and mortality.
Age ≥ 18 years.
Histologically confirmed malignant tumor of the abdomen or pelvis with planned radical or cytoreductive surgery.
Baseline malnutrition defined as NRS2002 ≥ 3 and at least one phenotypic and one etiologic GLIM criterion.
Expected postoperative hospitalization ≥ 7 days.
Severe decompensated hepatic or renal failure rendering surgery infeasible.
Documented preexisting severe cognitive impairment or dementia precluding valid postoperative cognitive/delirium assessment (e.g., MoCA < 18 or documented dementia).
Pregnancy or breastfeeding.
Participation in another interventional randomized clinical trial within the prior 30 days that could confound outcomes.
Adult patients (≥18 years) with histologically or cytologically confirmed abdominal or pelvic malignancy scheduled for major oncologic surgery (radical or cytoreductive), with pre existing malnutrition (NRS 2002 ≥3 and ≥1 phenotypic + ≥1 etiologic GLIM criterion), and expected postoperative hospital stay ≥7 days.
Cohort
Prospective
Serotonin (e.g., serotonin adipinate)
DrugParenteral serotonin administered postoperatively per treating physician's discretion. Dose, duration, and co-administration with other prokinetics recorded.
Standard Prokinetic Therapy (excluding serotonin)
DrugUse of metoclopramide, neostigmine, or other prokinetics per local practice, without serotonin.
Proportion of participants with LIFE ≤ 1 by postoperative day 5 (POD5 ±1 day)
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.
Mean LIFE score from postoperative day 1 through postoperative day 7
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.
Time to restoration of gastrointestinal motility (first spontaneous bowel movement without clinical signs of significant GID)
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).
Number of participants with at least one episode of delirium
Proportion of participants with at least one positive delirium assessment using CAM ICU or ICDSC during ICU and ward stay.
Number of delirium days
Total number of calendar days with positive CAM-ICU or ICDSC assessments.
Change in body weight
Difference in body weight (kg) between baseline and discharge.
Change in mid-upper arm circumference
Difference in mid upper arm circumference (cm) as a simple anthropometric marker of muscle mass.
Change in fat-free mass (FFM)
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.
Change in skeletal muscle mass (SMM)
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.
This trial is not recruiting at the moment. You can still explore other options:
