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Postoperative GI Dysfunction and Nutrition in Malnourished Cancer Surgery Patients

Study acronym: GIDNUT
StatusNot Yet Recruiting
PhaseNot specified
SponsorArma Ltd.
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07622888
Lead Sponsor Arma Ltd.
Conditions
(from sponsor)
Gastrointestinal Dysfunction, Malnutrition, Delirium - Postoperative, Abdominal Neoplasm, Pelvic Neoplasm
Related terms Abdominal Neoplasms, Emergence Delirium, Malnutrition, Pelvic Neoplasms
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov