Abdominal Neoplasm, Delirium - Postoperative, Gastrointestinal Dysfunction, Malnutrition, Pelvic Neoplasm
Conditions
Brief summary
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.
Detailed description
Disease-related malnutrition and sarcopenia are common in patients undergoing major abdominal or pelvic oncologic surgery and are associated with worse postoperative outcomes, including more complications, prolonged hospital stay, and increased mortality. Postoperative gastrointestinal dysfunction may further impair tolerance of enteral nutrition and delay recovery, especially in patients with baseline malnutrition. In routine practice at the participating centers, postoperative gastrointestinal dysfunction or functional ileus may be managed with different pharmacologic approaches, including metoclopramide, neostigmine, and in some patients parenteral serotonin. The choice of therapy, dose, timing, and duration is determined entirely by the treating clinicians according to routine care, approved labeling, and local institutional practice; no treatment is assigned by the protocol. This study prospectively enrolls approximately 120 adult patients with histologically or cytologically confirmed malignancy who are scheduled for major abdominal and/or pelvic oncologic surgery and have pre-existing malnutrition defined by NRS-2002 score at least 3 plus at least one phenotypic and one etiologic GLIM criterion. Participants are observed from the preoperative period through discharge or postoperative day 30, whichever occurs first. Exposure cohorts are defined after inclusion according to whether parenteral serotonin was actually received during the early postoperative period as part of routine care. The primary endpoint is the proportion of participants with regression of gastrointestinal dysfunction to LIFE score less than or equal to 1 by postoperative day 5 within the postoperative day 4 to 6 assessment window. Secondary outcomes include the trajectory of LIFE scores during postoperative days 1 to 7, time to restoration of gastrointestinal motility, time to achievement of at least 60 to 70 percent of calculated energy requirements via enteral nutrition, changes in nutritional status and body composition, delirium incidence and duration, postoperative complications graded by Clavien-Dindo, infectious complications, ICU and hospital length of stay, and mortality. The study is exploratory and is intended to characterize real-world postoperative trajectories and generate effect-size estimates for future studies rather than provide definitive proof of treatment superiority.
Interventions
DRUGSerotonin (e.g., serotonin adipinate)
Parenteral serotonin administered postoperatively per treating physician's discretion. Dose, duration, and co-administration with other prokinetics recorded.
DRUGStandard Prokinetic Therapy (excluding serotonin)
Use of metoclopramide, neostigmine, or other prokinetics per local practice, without serotonin.
Sponsors
Arma Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with LIFE ≤ 1 by postoperative day 5 (POD5 ±1 day) | Postoperative day (POD) 5 ± 1 day (assessment window POD4-POD6) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean LIFE score from postoperative day 1 through postoperative day 7 | Postoperative Days 1-7 | 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) | From the date of surgery until the date of the first documented spontaneous bowel movement without clinically significant gastrointestinal dysfunction, assessed up to 30 days after surgery | 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 | From postoperative day 0 through postoperative day 10 after surgery or until hospital discharge, whichever occurs first. | Proportion of participants with at least one positive delirium assessment using CAM ICU or ICDSC during ICU and ward stay. |
| Number of delirium days | From postoperative day 0 through postoperative day 10 after surgery or until hospital discharge, whichever occurs first. | Total number of calendar days with positive CAM-ICU or ICDSC assessments. |
| Frequency of surgical complications (Clavien-Dindo, grade II-V) | Up to 30 days after surgery | Proportion of participants who develop at least one postoperative complication of Clavien-Dindo grade II or higher; separate reporting of grade III-V complications. |
| Frequency of infectious complications | Up to 30 days after surgery | Proportion of participants with clinically diagnosed infectious complications (e.g., surgical site infection, pneumonia, intra abdominal abscess, sepsis) during the index hospitalization. |
| ICU length of stay (days) and hospital length of stay (days) | Up to 30 days after surgery | Number of days spent * in the ICU during the index postoperative stay * in the hospital for the index surgical admission. |
| In-hospital mortality and 30-day mortality | Up to 30 days after surgery | 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. |
| Safety outcomes (CTCAE v6.0) | From the index hospitalization through 30 days after surgery | 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 |
Countries
Russia
Contacts
CONTACTIgor Vrublevskii
Outcome results
None listed