Viewing Study NCT06186089



Ignite Creation Date: 2024-05-06 @ 7:56 PM
Last Modification Date: 2024-10-26 @ 3:16 PM
Study NCT ID: NCT06186089
Status: RECRUITING
Last Update Posted: 2024-04-11
First Post: 2023-12-07

Brief Title: Effect of Gastrectomy on Gut Microbiome and Cognitive Function
Sponsor: Jiangjiang Bi
Organization: Tongji Hospital

Study Overview

Official Title: Effects of Total Gastrectomy or Double Track Reconstruction on Gut Microbiome and Cognitive Function in Patients With Proximal Gastric Cancer
Status: RECRUITING
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: Perioperative neurocognitive disorders is a common postoperative complication in elderly surgical patients especially in gastrointestinal tumors and cardiac on-pump surgery and the mechanism is not clear yet The role of gut microbiota in cognitive function has been concerned in recent years and the applicants previous study also found significant differences in the composition of gut microbiota and metabolites in elderly orthopedic surgical patients with postoperative cognitive dysfunction compared with the control group and that the differential metabolites were mainly enriched in the metabolic pathway of protein digestion and absorption Studies suggests that gastrointestinal surgery may affect the gut microbiota and the effect varies between surgical procedures The incidence of proximal gastric cancer is increasing In order to prevent severe gastroesophageal reflux total gastrectomy is mostly performed However after total gastrectomy food directly enters into the intestine followed by insufficient mixing of gastric acid and food Patients are prone to nutrient absorption disorders which may cause changes in gut microbiota The double-tract reconstruction allows food to enter the distal gastrointestinal tract via two pathways successfully solving the problems of gastroesophageal reflux gastroparesis and long-term nutritional disorders in patients after proximal gastrectomy In this study the investigators aim 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 The investigators will compare the differences of gut microbiota between total gastrectomy and double-tract reconstruction by 16S ribosomal ribonucleic acid rRNA gene sequencing and metabonomics technology and evaluate the postoperative cognitive function by Mini-mental State Examination scales and Montreal Cognitive Assessment scales

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None