NCT06277518

Brief Summary

Postoperative admission to ICU for patients with digestive system tumors is one of the most common postoperative complications of all non-cardiac surgeries. The study found that supportive treatment of critically ill patients admitted to ICU after surgery was conducive to reducing mortality, and the most common complications of postoperative ICU admission were infections, especially respiratory infections and surgical site infections. A growing body of evidence supports that ICU stays are expensive, always occupy major hospital resources, and are associated with the worst outcomes. To date, there is insufficient evidence to determine which patients with digestive system tumors benefit the most from being admitted to the ICU after surgery. Therefore, this study intends to adopt retrospective study to determine the risk factors of postoperative ICU transfer for patients with digestive system malignant tumor, and build a risk prediction model for postoperative ICU admission, so as to guide the decision of postoperative ICU transfer for patients with digestive system malignant tumor.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not 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 Progress96%
Sep 2023Jun 2026

Study Start

First participant enrolled

September 20, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2026

Expected
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

2.2 years

First QC Date

February 19, 2024

Last Update Submit

February 19, 2024

Conditions

Keywords

Malignant tumors of digestive systemIntensive care Unitrisk factorspredictive models

Outcome Measures

Primary Outcomes (1)

  • admitted to ICU after surgery

    whether the patient was admitted to ICU after surgery or within three days

    the day and three days after surgery

Study Arms (1)

observation group,

the risk factors of patients with malignant tumors of digestive system meeting the inclusion criteria were observed without special intervention

Procedure: Surgery for malignant tumors of the digestive system

Interventions

Related treatment or palliative surgery under general anesthesia for digestive system malignancies

observation group,

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing surgery for malignant tumors of digestive system under general anesthesia in Shaanxi Provincial Cancer Hospital and Ningxia Medical University General Hospital from January 2019 to December 2023

You may qualify if:

  • Postoperative patients with malignant tumor of digestive system under general anesthesia, ASA Ⅱ\~ Ⅳ

You may not qualify if:

  • Emergency operation, operation stopped after entering the operating room, ASA \> Ⅳ

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

  • Liqin Deng, M.D

    General Hospital of Ningxia Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2024

First Posted

February 26, 2024

Study Start

September 20, 2023

Primary Completion

December 1, 2025

Study Completion (Estimated)

June 20, 2026

Last Updated

February 26, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations