An observational study in Gastrointestinal Dysfunction, Malnutrition and Delirium - Postoperative, sponsored by Arma Ltd.. Not yet recruiting at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by Arma Ltd. · Observational
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.
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.
1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.
This study's planned enrollment of 120 is below the median of 206 across 393 observational studies indexed under Malnutrition.
Browse Malnutrition studies →This is the only study on the registry with Arma Ltd. as lead sponsor.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Serotonin (e.g., serotonin adipinate)
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.
Drug: Standard Prokinetic Therapy (excluding serotonin)
Parenteral serotonin administered postoperatively per treating physician's discretion. Dose, duration, and co-administration with other prokinetics recorded.
Use 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.
Time frame: Postoperative day (POD) 5 ± 1 day (assessment window POD4-POD6)
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 frame: Postoperative Days 1-7
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).
Time frame: 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 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.
Time frame: From postoperative day 0 through postoperative day 10 after surgery or until hospital discharge, whichever occurs first.
Number of delirium days
Total number of calendar days with positive CAM-ICU or ICDSC assessments.
Time frame: From postoperative day 0 through postoperative day 10 after surgery or until hospital discharge, whichever occurs first.
Frequency of surgical complications (Clavien-Dindo, grade II-V)
Proportion of participants who develop at least one postoperative complication of Clavien-Dindo grade II or higher; separate reporting of grade III-V complications.
Time frame: Up to 30 days after surgery
Frequency of infectious complications
Proportion of participants with clinically diagnosed infectious complications (e.g., surgical site infection, pneumonia, intra abdominal abscess, sepsis) during the index hospitalization.
Time frame: Up to 30 days after surgery
ICU length of stay (days) and hospital length of stay (days)
Number of days spent * in the ICU during the index postoperative stay * in the hospital for the index surgical admission.
Time frame: Up to 30 days after surgery
In-hospital mortality and 30-day mortality
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.
Time frame: Up to 30 days after surgery
Safety outcomes (CTCAE v6.0)
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
Time frame: From the index hospitalization through 30 days after surgery
Change in body weight
Difference in body weight (kg) between baseline and discharge.
Time frame: From preoperative baseline to hospital discharge, assessed up to 30 days after surgery.
Change in mid-upper arm circumference
Difference in mid upper arm circumference (cm) as a simple anthropometric marker of muscle mass.
Time frame: From preoperative baseline assessment to the day of hospital discharge, assessed up to 30 days after surgery
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.
Time frame: Postoperative Day 6-10 or at hospital discharge, whichever occurs first
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.
Time frame: Postoperative Day 6-10
Change in skeletal muscle mass index (SMMI)
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.
Time frame: Postoperative Day 6-10 or at hospital discharge, whichever occurs first
Change in phase angle
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.
Time frame: Postoperative Day 6-10 or at hospital discharge, whichever occurs first
Change in Nutritional Risk Screening 2002 (NRS-2002) score from baseline to discharge
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).
Time frame: From preoperative baseline assessment to the day of hospital discharge, assessed up to 30 days after surgery
Change in Global Leadership Initiative on Malnutrition (GLIM) malnutrition severity category from baseline to discharge
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).
Time frame: From preoperative baseline assessment to the day of hospital discharge, assessed up to 30 days after surgery
Change in Patient-Generated Subjective Global Assessment (PG-SGA) total score from baseline to discharge
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).
Time frame: From preoperative baseline assessment to the day of hospital discharge, assessed up to 30 days after surgery
Time to achievement of enteral nutrition ≥60-70% of calculated energy requirement
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).
Time frame: From initiation of postoperative nutritional support up to 30 days after surgery
Plan to share: No — IPD might not be shared due to national law
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