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Postoperative GI Dysfunction and Nutrition in Malnourished Cancer Surgery Patients

NCT07622888 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-06-03

No results posted yet for this study

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.

Conditions

  • Gastrointestinal Dysfunction
  • Malnutrition
  • Delirium - Postoperative
  • Abdominal Neoplasm
  • Pelvic Neoplasm

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.

Sponsors & Collaborators

  • Arma Ltd.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2028-10-31
Completion
2029-03-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07622888 on ClinicalTrials.gov