Gastrointestinal DysfunctionGIDNUTNCT07622888
Postoperative GI Dysfunction and Nutrition in Malnourished Cancer Surgery Patients
An observational study of Gastrointestinal Dysfunction and Malnutrition, run by Arma Ltd. at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Dysfunction, Malnutrition, Delirium - Postoperative
- What is being tested?
- Serotonin (e.g., serotonin adipinate) and Standard Prokinetic Therapy (excluding serotonin)
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 1 Oct 2026to 1 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site
North-Western District Scientific and Clinical Center named after L.G. Sokolov, FMBA of Russia
Saint Petersburg, 194291
About this study
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
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.
Read the detailed description
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.
- Conditions
- Gastrointestinal Dysfunction, Malnutrition, Delirium - Postoperative, Abdominal Neoplasm, Pelvic Neoplasm
- Being tested
- Serotonin (e.g., serotonin adipinate), Standard Prokinetic Therapy (excluding serotonin)
- Medical subject headings
- Malnutrition, Emergence Delirium, Abdominal Neoplasms, Pelvic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serotonin (e.g., serotonin adipinate)Drug
Parenteral serotonin administered postoperatively per treating physician's discretion. Dose, duration, and co-administration with other prokinetics recorded.
Standard Prokinetic Therapy (excluding serotonin)Drug
Use of metoclopramide, neostigmine, or other prokinetics per local practice, without serotonin.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Standard Prokinetic Therapy (excluding serotonin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative day (POD) 5 ± 1 day (assessment window POD4-POD6)
Secondary outcomes (9)
Mean LIFE score from postoperative day 1 through postoperative day 7
Average of daily LIFE scores measured once per day from POD1 to POD7. LIFE is a composite clinical score of gastrointestinal dysfunction. Mean LIFE over this period will be compared between serotonin exposed and non exposed cohorts to describe the trajectory of GI function.
Measured: Postoperative Days 1-7
Time to restoration of gastrointestinal motility (first spontaneous bowel movement without clinical signs of significant GID)
Number of days from surgery to the first documented spontaneous bowel movement without clinically significant ongoing gastrointestinal dysfunction (as judged by the treating team and LIFE score).
Measured: 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
Proportion of participants with at least one positive delirium assessment using CAM ICU or ICDSC during ICU and ward stay.
Measured: From postoperative day 0 through postoperative day 10 after surgery or until hospital discharge, whichever occurs first.
Number of delirium days
Total number of calendar days with positive CAM-ICU or ICDSC assessments.
Measured: 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)
Proportion of participants who develop at least one postoperative complication of Clavien-Dindo grade II or higher; separate reporting of grade III-V complications.
Measured: Up to 30 days after surgery
Frequency of infectious complications
Proportion of participants with clinically diagnosed infectious complications (e.g., surgical site infection, pneumonia, intra abdominal abscess, sepsis) during the index hospitalization.
Measured: Up to 30 days after surgery
ICU length of stay (days) and hospital length of stay (days)
Number of days spent
- in the ICU during the index postoperative stay
- in the hospital for the index surgical admission.
Measured: Up to 30 days after surgery
In-hospital mortality and 30-day mortality
Proportion of participants who die
- before discharge from the index hospitalization
- within 30 days after surgery, based on hospital records and, where available, follow up information.
Measured: Up to 30 days after surgery
Safety outcomes (CTCAE v6.0)
Incidence of cardiovascular, hematologic, metabolic, and neuropsychiatric adverse events with emphasis on thrombotic events, serious arrhythmias, severe hypertensive reactions, and events compatible with serotonin syndrome
Measured: From the index hospitalization through 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622888
- Sponsor's protocol ID
- ARMA-GIDNUT-O-2026-01
- Acronym
- GIDNUT
- Status last verified
- May 2026
- First submitted
- 18 Apr 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD might not be shared due to national law
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07622888
- Acronym / sponsor ID
- GIDNUT / ARMA-GIDNUT-O-2026-01
- Conditions
- Gastrointestinal Dysfunction, Malnutrition, Delirium - Postoperative, Abdominal Neoplasm, Pelvic Neoplasm
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Arma Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serotonin Cohort | – | Drug: Serotonin (e.g., serotonin adipinate)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. |
| No Serotonin Cohort | – | Drug: Standard Prokinetic Therapy (excluding serotonin)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serotonin (e.g., serotonin adipinate)Parenteral serotonin administered postoperatively per treating physician's discretion. Dose, duration, and co-administration with other prokinetics recorded. | Drug | Serotonin Cohort |
| Standard Prokinetic Therapy (excluding serotonin)Use of metoclopramide, neostigmine, or other prokinetics per local practice, without serotonin. | Drug | No Serotonin Cohort |
Primary outcome
Proportion of participants with LIFE ≤ 1 by postoperative day 5 (POD5 ±1 day)
Time frame: Postoperative day (POD) 5 ± 1 day (assessment window POD4-POD6)
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.
9 secondary outcomes
Mean LIFE score from postoperative day 1 through postoperative day 7
Time frame: Postoperative Days 1-7
Time to restoration of gastrointestinal motility (first spontaneous bowel movement without clinical signs of significant GID)
Time frame: 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
Time frame: From postoperative day 0 through postoperative day 10 after surgery or until hospital discharge, whichever occurs first.
Number of delirium days
Time frame: 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)
Time frame: Up to 30 days after surgery
Frequency of infectious complications
Time frame: Up to 30 days after surgery
ICU length of stay (days) and hospital length of stay (days)
Time frame: Up to 30 days after surgery
In-hospital mortality and 30-day mortality
Time frame: Up to 30 days after surgery
Safety outcomes (CTCAE v6.0)
Time frame: From the index hospitalization through 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No. IPD might not be shared due to national law
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Dysfunction and Malnutrition, run by Arma Ltd. at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Igor Vrublevskii (+79672769997, tender@ph-arma.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with LIFE ≤ 1 by postoperative day 5 (POD5 ±1 day) (time frame: Postoperative day (POD) 5 ± 1 day (assessment window POD4-POD6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.