Postoperative GI Dysfunction and Nutrition in Malnourished Cancer Surgery Patients

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.

• Mean LIFE score from postoperative day 1 through postoperative day 7 [Срок оценки: Postoperative Days 1-7]
• Time to restoration of gastrointestinal motility (first spontaneous bowel movement without clinical signs of significant GID) [Срок оценки: 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 [Срок оценки: From postoperative day 0 through postoperative day 10 after surgery or until hospital discharge, whichever occurs first.]
• Number of delirium days [Срок оценки: 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) [Срок оценки: Up to 30 days after surgery]
• Frequency of infectious complications [Срок оценки: Up to 30 days after surgery]
• ICU length of stay (days) and hospital length of stay (days) [Срок оценки: Up to 30 days after surgery]
• In-hospital mortality and 30-day mortality [Срок оценки: Up to 30 days after surgery]
• Safety outcomes (CTCAE v6.0) [Срок оценки: From the index hospitalization through 30 days after surgery]