Clinical trial · Observational
Postoperative GI Dysfunction and Nutrition in Malnourished Cancer Surgery Patients
Gastrointestinal Dysfunction, Nutritional Status, and Delirium in the Early Postoperative Period in Oncologic Surgical Patients With Pre-existing Malnutrition: A Prospective Two-Center Observational Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal Neoplasm | — | UNRESOLVED | — |
| Delirium - Postoperative | — | UNRESOLVED | — |
| Gastrointestinal Dysfunction | — | UNRESOLVED | — |
| Malnutrition | — | UNRESOLVED | — |
| Pelvic Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Serotonin (e.g., serotonin adipinate) | Drug | — | UNRESOLVED |
| Standard Prokinetic Therapy (excluding serotonin) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Serotonin Cohort
- description
- Participants who receive parenteral serotonin, such as serotonin adipinate, at any time during the early postoperative period as part of routine clinical management of postoperative gastrointestinal dysfunction or functional ileus, at the discretion of the treating physician. Exposure is observed and recorded; it is not assigned by protocol.
- interventionNames
- Drug: Serotonin (e.g., serotonin adipinate)
- label
- No Serotonin Cohort
- description
- Participants who do not receive parenteral serotonin during the index hospitalization. Other standard prokinetic agents, including metoclopramide or neostigmine, may be used according to routine clinical care. Exposure is observed and recorded; it is not assigned by protocol.
- interventionNames
- Drug: Standard Prokinetic Therapy (excluding serotonin)
Primary outcomes (1)
- measure
- Proportion of participants with LIFE ≤ 1 by postoperative day 5 (POD5 ±1 day)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. * Ability to undergo baseline cognitive and nutritional assessments (MoCA, NRS2002, GLIM, PG-SGA) prior to surgery. * Signed informed consent for participation and data collection. Exclusion Criteria: * 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. * Inability to ensure postoperative follow-up or reliable data collection (planned transfer without access, loss of contact).
References
Publications (0)
Data not yet available