Effect of Gastrectomy on Gut Microbiome and Cognitive Function
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-80
SponsorJiangjiang Bi
About this trial
Perioperative neurocognitive disorders is a common postoperative complication in elderly surgical patients. The role of gut microbiota in cognitive function has been concerned in recent years. Studies suggests that gastrointestinal surgery may affect the gut microbiota, and the effect varies between surgical procedures. In this study, the investigators will compare the differences of gut microbiota between total gastrectomy and double-tract reconstruction, to investigate the effect of gastric acid on the gut microbiota colonizing, and the effect of different surgical procedures on the postoperative cognitive function of proximal gastric cancer patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of proximal gastric cancer and will be performed gastrectomy
American Society of Anesthesiologists (ASA) classification I-III
Aged 40-80 years
Perioperative consciousness
Disqualifiers
Central nervous system and psychological disorders
Chronic use of sedatives, antidepressants within the last year
Parkinson's disease
Severe immunosuppression
Trial population
Patients undergoing proximal gastric cancer surgery with general anesthesia
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
probiotics
Dietary supplementpatients undergoing total gastrectomy take probiotics qd for 3 months
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Probiotics (PR)1 intervention
Group B: Total gastrectomy (TG)0 interventions
Group C: Double-tract reconstruction (DTR)0 interventions
Trial outcomes
Primary outcomes
1
Cognitive function
The participants will be evaluated by Mini-mental State Examination scales, and diagnosed as cognitive dysfunction if score \< 24.
Time frame
1 day before surgery; 1 day, 7 days, 3 months and 12 months after surgery2
Cognitive function
The participants will be evaluated by Montreal Cognitive Assessment scales, diagnosed as cognitive dysfunction if score \< 26
Time frame
1 day before surgery; 1 day, 7 days, 3 months and 12 months after surgery3
Composition and diversity of gut microbiota
It will be tested by 16s rRNA gene sequencing.
Time frame
1 day before surgery and 7 days after surgerySecondary outcomes
1
Inflammatory factor
Interleukin-1β (IL-1β), IL-6, tumor necrosis factor-α (TNF-α), C reactive protein (CRP) will be tested by ELISA kit.
Time frame
preoperation, 30 minutes and 24 hours after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Jiangjiang Bi
Lead sponsor
Tongji Hospital
Sponsor institution
Source ClinicalTrials.gov