Postoperative GI Dysfunction and Nutrition in Malnourished Cancer Surgery Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Serotonin (e.g., serotonin adipinate), Standard Prokinetic Therapy (excluding serotonin).
- Who it may be relevant to
- Registry conditions: Gastrointestinal Dysfunction, Malnutrition, Delirium - Postoperative, Abdominal Neoplasm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
- Drug Serotonin (e.g., serotonin adipinate)
Parenteral serotonin administered postoperatively per treating physician's discretion. Dose, duration, and co-administration with other prokinetics recorded. - Drug Standard Prokinetic Therapy (excluding serotonin)
Use of metoclopramide, neostigmine, or other prokinetics per local practice, without serotonin.
Primary outcome measures
- Proportion of participants with LIFE ≤ 1 by postoperative day 5 (POD5 ±1 day) [Time frame: Postoperative day (POD) 5 ± 1 day (assessment window POD4-POD6)]
Secondary outcome measures (9)
- Mean LIFE score from postoperative day 1 through postoperative day 7 [Time frame: Postoperative Days 1-7]
- Time to restoration of gastrointestinal motility (first spontaneous bowel movement without clinical signs of significant GID) [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 [Time frame: From postoperative day 0 through postoperative day 10 after surgery or until hospital discharge, whichever occurs first.]
- Number of delirium days [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) [Time frame: Up to 30 days after surgery]
- Frequency of infectious complications [Time frame: Up to 30 days after surgery]
- ICU length of stay (days) and hospital length of stay (days) [Time frame: Up to 30 days after surgery]
- In-hospital mortality and 30-day mortality [Time frame: Up to 30 days after surgery]
- Safety outcomes (CTCAE v6.0) [Time frame: From the index hospitalization through 30 days after surgery]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Russia · 1 center
- North-Western District Scientific and Clinical Center named after L.G. Sokolov, FMBA of Ru — Saint Petersburg
Identifiers
NCT: NCT07622888 · ARMA-GIDNUT-O-2026-01