Correlation Analysis of POD and pNCD in Elderly Patients With Gastrointestinal Neoplasms

NCT06466096 | Recruiting

• 1 other identifier: 27961988
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective cohort study to explore the differences of serum indicators between elderly gastrointestinal neoplasms patients with postoperative delirium (POD) who either develop or do not develop long-term postoperative neurocognitive disorders (pNCD).

Conditions

Postoperative Delirium; Postoperative Neurocognitive Disorder; Gastrointestinal Surgery

Keywords

postoperative delirium; postoperative neurocognitive disorder; serum indicators; gastrointestinal neoplasms surgery

Outcome Measures

Primary Outcomes (1)

• the changes of blood biomarkers before and after surgery between elderly gastrointestinal neoplasms patients with postoperative delirium (POD) who either develop or do not develop postoperative neurocognitive disorders (pNCD) one month after surgery

  Perioperative changes in blood-based biomarkers can reflect the pathophysiological processes of diseases. Current studies indicate that the perioperative levels of blood-based biomarkers may be associated with postoperative neurocognitive disorders in elderly patients. These blood-based biomarkers may provide novel avenues for the early diagnosis, prevention, and improvement of outcomes in elderly patients with postoperative neurocognitive disorders. The procedures are as follows: Neurocognitive function assessments were conducted on the enrolled patients within one week before surgery, one month after surgery, and twelve months after surgery, respectively. Whether the patients developed postoperative delirium was evaluated within seven days after surgery. Venous blood was drawn before surgery and within three days after surgery to detect the levels of brain-derived neurotrophic factor (BDNF), high-sensitivity C-reactive protein (hs-CRP), and homocysteine (Hcy).

  2024.5.9-2026.6.1

Study Arms (1)

postoperative delirium(POD) and postoperative neurocognitive disorder(pNCD)

Delirium (CAM scale ) was assessed 7 days after surgery and divided into POD and non-POD groups; one of the above scenarios indicated postoperative delirium;The patients in the POD group were evaluated for cognitive function at 1 month and 12 months after surgery to determine whether pNCD occurred. The patients in the POD group were further divided into pNCD subgroup and non-PNCD subgroup, and the changes of serum indicators before and after surgery in the pNCD and non-pNCD subgroups were compared.

Other: no intervention

Interventions

no intervention OTHER

this is an observation study, no intervention

postoperative delirium(POD) and postoperative neurocognitive disorder(pNCD)

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients 65\~100 years of age who have undergone surgical anesthesia of gastrointestinal neoplasms

You may qualify if:

• Patients ≥65 years of age who have undergone surgical anesthesia of gastrointestinal neoplasms; Sign informed consent.

You may not qualify if:

• Inability to complete cognitive function assessment; Illiteracy, hearing impairment or visual impairment; He has a history of epilepsy, depression, schizophrenia, Alzheimer's disease and other psychiatric and neurological diseases.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Lei Zhao, Doctor's

CONTACT

+8613811035886; zhaoalei@sina.com

Manke Luo, Bachelor's

CONTACT

+8615508707563; uni1586830032@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 20, 2024
• Study Start: October 18, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)