NCT07406269

Brief Summary

After gastrointestinal or oncology surgery, it can be difficult to determine when a patient is ready to safely begin early rehabilitation or move toward discharge. Delays may prolong hospital stay, while premature decisions may increase risks. This study evaluates an artificial intelligence (AI)-based decision support tool that analyzes routinely collected hospital data to identify patients who are likely ready for early rehabilitation and discharge planning after surgery. The tool provides a simple yes/no output to support clinicians in their decision-making. The AI tool does not replace clinical judgment. Treating physicians remain fully responsible for all care decisions. The purpose of this study is to examine how well this tool performs in clinical practice and how it can be safely and effectively implemented to support postoperative care.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Jun 2026Jul 2027

First Submitted

Initial submission to the registry

February 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

February 6, 2026

Last Update Submit

February 6, 2026

Conditions

Keywords

Artificial IntelligenceClinical Decision Support SystemPostoperative CareEarly RehabilitationGastrointestinal SurgeryOncological SurgeryPredictive Modeling

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients requiring unplanned escalation of hospital-specific care within 30 days after early transfer to rehabilitation area.

    This is a composite outcome, consisting of any of the following events: ICU admission Re-operation Radiological intervention Administration of intravenous antibiotics Respiratory failure (new need for supplemental oxygen) 30-day mortality 30-day emergency readmission

    From postoperative day 2 (time of AI prediction and potential transfer to rehabilitation area) through 30 days after surgery

Study Arms (1)

Cohort of 103 patients undergoing GE/oncological surgery and admitted >2 days after surgery

EXPERIMENTAL
Device: DESIRE: AI-Based Clinical Decision Support for Postoperative Rehabilitation Planning

Interventions

The intervention consists of the clinical use of a locked, non-adaptive artificial intelligence (AI)-based clinical decision support system (DESIRE) that analyzes routinely collected electronic health record data to predict, on postoperative day 2, the risk that a patient will require hospital-specific interventions after gastrointestinal or oncological surgery. The system automatically extracts demographic, perioperative, vital sign, laboratory, and medication-related variables and generates a binary (yes/no) output indicating whether the patient is likely to be at low risk for requiring additional hospital care. A predefined conservative threshold is used to identify patients eligible for early rehabilitation.

Cohort of 103 patients undergoing GE/oncological surgery and admitted >2 days after surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 years or older
  • Undergoing gastrointestinal or oncological surgery
  • Postoperatively admitted to the surgical ward
  • Expected to remain admitted for at least 2 days after surgery

You may not qualify if:

  • Admitted to the intensive care unit (ICU) at the time of prediction on postoperative day 2
  • Inability to provide informed consent in Dutch or English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus MC, University Medical Center Rotterdam

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Central Study Contacts

Denise Hilling, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgeon and Data Scientist

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 12, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

February 12, 2026

Record last verified: 2026-02

Locations