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NOT YET RECRUITING
NCT07622888

Postoperative GI Dysfunction and Nutrition in Malnourished Cancer Surgery Patients

Sponsor: Arma Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2026-10-01

Completion Date

2029-03-01

Last Updated

2026-06-03

Healthy Volunteers

No

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.

Locations (1)

North-Western District Scientific and Clinical Center named after L.G. Sokolov, FMBA of Russia

Saint Petersburg, Russia