Actively Recruiting

Age: 40Years - 80Years
All Genders
ID06186089

Effects of Total Gastrectomy or Double-Tract Reconstruction on Gut Microbiome and Cognitive Function in Patients With Proximal Gastric Cancer

Led by Jiangjiang Bi · Updated on 2024-04-11

45

Participants Needed

1

Research Sites

26 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are investigating perioperative neurocognitive disorders, a common complication after surgery in elderly patients, especially those with gastrointestinal tumors like proximal gastric cancer. This study aims to understand how different surgical procedures, total gastrectomy and double-tract reconstruction, affect gut microbiota and postoperative cognitive function. The role of gastric acid in shaping gut bacteria and its link to cognitive health is a key focus. The study compares patients undergoing total gastrectomy, who will take probiotics daily for three months after surgery, with those receiving double-tract reconstruction. Researchers will analyze gut microbiota differences using 16S rRNA gene sequencing and metabonomics technology. Cognitive function will be assessed using the Mini-Mental State Examination and Montreal Cognitive Assessment scales at multiple time points: before surgery, and 1 day, 7 days, 3 months, and 12 months after surgery. Participants will have their cognitive function and gut microbiota monitored before and after surgery, along with inflammatory markers measured before, 30 minutes, and 24 hours after surgery. The study involves assessments over one year to track changes and effects of the surgical methods on brain function and gut bacteria. This ongoing evaluation aims to better understand how surgery impacts recovery and cognition in proximal gastric cancer patients.

CONDITIONS

Brief Title

Effect of Gastrectomy on Gut Microbiome and Cognitive Function

Who Can Participate

Age: 40Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of proximal gastric cancer with planned gastrectomy
  • American Society of Anesthesiologists (ASA) classification I-III
  • Age between 40 and 80 years
  • Conscious during the perioperative period
Not Eligible

You will not qualify if you...

  • Central nervous system or psychological disorders
  • Chronic use of sedatives or antidepressants within the last year
  • Parkinson's disease
  • Severe immunosuppression
  • Severe hearing or vision impairment
  • Drug dependence or alcoholism
  • Inability to communicate with a physician

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo total gastrectomy or double-tract reconstruction surgery. Immediate post-operative care includes monitoring inflammatory factors shortly before and after surgery.

1 surgery day visit and monitoring at preoperation, 30 minutes and 24 hours post-surgery

Treatment

Duration - 3 months

Participants undergoing total gastrectomy take probiotics once daily for 3 months after surgery.

Daily probiotic intake with regular check-ins

Post-operative Follow-up

Duration - 12 months

Participants have their cognitive function and gut microbiota composition assessed at multiple time points after surgery to monitor recovery and treatment effects.

Visits 1 day before surgery; 1 day, 7 days, 3 months, and 12 months after surgery

Trial Site Locations

Total: 1 location

1

Tongji Hospital

Wuhan, Hubei, China, 430030

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Research Team

J

Jiangjiang Bi, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

Contribution of preoperative gut microbiota in postoperative neurocognitive dysfunction in elderly patients undergoing orthopedic surgery.

Jiangjiang Bi, Yifan Xu, Shiyong Li...

https://pubmed.ncbi.nlm.nih.gov/36875700

Influence of gastrectomy for gastric cancer treatment on faecal microbiome and metabolome profiles.

Pande Putu Erawijantari, Sayaka Mizutani, Hirotsugu Shiroma...

https://pubmed.ncbi.nlm.nih.gov/31953253

Differences in Alimentary Glucose Absorption and Intestinal Disposal of Blood Glucose After Roux-en-Y Gastric Bypass vs Sleeve Gastrectomy.

Jean-Baptiste Cavin, Anne Couvelard, Rachida Lebtahi...

https://pubmed.ncbi.nlm.nih.gov/26481855