Postoperative GI Dysfunction and Nutrition in Malnourished Cancer Surgery Patients

NCT07622888 | Not Yet Recruiting

• 1 other identifier: ARMA-GIDNUT-O-2026-01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

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

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with LIFE ≤ 1 by postoperative day 5 (POD5 ±1 day)

  The proportion of participants whose gastrointestinal dysfunction regresses to a Lausanne Intestinal Failure Estimation (LIFE) score of ≤1 within the assessment window (POD4-POD6). LIFE is assessed once daily from POD1 through POD7 using routine clinical parameters.

  Postoperative day (POD) 5 ± 1 day (assessment window POD4-POD6)

Secondary Outcomes (9)

• Mean LIFE score from postoperative day 1 through postoperative day 7

  Postoperative Days 1-7

• Time to restoration of gastrointestinal motility (first spontaneous bowel movement without clinical signs of significant GID)

  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

  From postoperative day 0 through postoperative day 10 after surgery or until hospital discharge, whichever occurs first.

• Number of delirium days

  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)

  Up to 30 days after surgery

Other Outcomes (10)

• Change in body weight

  From preoperative baseline to hospital discharge, assessed up to 30 days after surgery.

• Change in mid-upper arm circumference

  From preoperative baseline assessment to the day of hospital discharge, assessed up to 30 days after surgery

• Change in fat-free mass (FFM)

  Postoperative Day 6-10 or at hospital discharge, whichever occurs first

Study Arms (2)

Serotonin Cohort

Participants who receive parenteral serotonin, such as serotonin adipinate, at any time during the early postoperative period as part of routine clinical management of postoperative gastrointestinal dysfunction or functional ileus, at the discretion of the treating physician. Exposure is observed and recorded; it is not assigned by protocol.

Drug: Serotonin (e.g., serotonin adipinate)

No Serotonin Cohort

Participants who do not receive parenteral serotonin during the index hospitalization. Other standard prokinetic agents, including metoclopramide or neostigmine, may be used according to routine clinical care. Exposure is observed and recorded; it is not assigned by protocol.

Drug: Standard Prokinetic Therapy (excluding serotonin)

Interventions

Serotonin (e.g., serotonin adipinate) DRUG

Parenteral serotonin administered postoperatively per treating physician's discretion. Dose, duration, and co-administration with other prokinetics recorded.

Serotonin Cohort

Standard Prokinetic Therapy (excluding serotonin) DRUG

Use of metoclopramide, neostigmine, or other prokinetics per local practice, without serotonin.

No Serotonin Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) with histologically or cytologically confirmed abdominal or pelvic malignancy scheduled for major oncologic surgery (radical or cytoreductive), with pre existing malnutrition (NRS 2002 ≥3 and ≥1 phenotypic + ≥1 etiologic GLIM criterion), and expected postoperative hospital stay ≥7 days.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Arma Ltd.: lead

Study Sites (1)

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

Saint Petersburg, 194291, Russia

Location

MeSH Terms

Conditions

Malnutrition; Emergence Delirium; Abdominal Neoplasms; Pelvic Neoplasms

Interventions

Serotonin; serotonin adipinate

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Tryptamines; Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Autacoids; Inflammation Mediators; Biological Factors

Central Study Contacts

Igor Vrublevskii

CONTACT

+79672769997; tender@ph-arma.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)