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Active Not RecruitingNCT06489288

ERAS in Totally Laparoscopic Total Gastrectomy for Gastric Cancer

The Safety and Efficacy of ERAS Clinical Pathway Intotally Laparoscopic Total Gastrectomy: a Multicenter, Prospective Randomized Controlled Study

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
2,656 (estimated)
Sponsor
Xijing Hospital · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

The number of totally laparoscopic total gastrectomy is gradually increasing, but the safety of ERAS in these term is still unknown and further multicenter randomized controlled studies are needed.

Detailed description

The application of ERAS during the perioperative of gastric cancer surgery can reduce hospitalization time, costs, and surgical stress response without increasing complications and readmission rates, and may even have a certain effect on improving long-term survival rates of patients. However, some studies have also shown that ERAS may increase the number of postoperative readmissions while reducing hospitalization time, costs, and recovery time after surgery. At the same time, there is still no consensus on the application standards of ERAS during the perioperative period of gastric cancer surgery , and the comprehensive implementation of ERAS programs in clinical practice still faces huge challenges. With the widespread development of totally laparoscopic total gastrectomy , the advantages of laparoscopy have been recognized. Multiple center studies have confirmed the safety of ERAS programs in totally laparoscopic distal radical gastrectomy. However, due to the complexity of totally laparoscopic total gastrectomy, there is currently no multi-center study to confirm the safety of ERAS in it. In order to better apply ERAS in clinical practice, better serve patients undergoing gastric cancer surgery, and provide more centers with practical experience in ERAS and even provide evidence for the establishment of a consensus on ERAS during the perioperative of gastric cancer surgery, our center will rely on platform advantages and previous work experience and collaborate with the CLASS Research Center to conduct a prospective, multi-center clinical study to explore the safety and effectiveness of ERAS clinical pathway in patients undergoing totally laparoscopic total gastrectomy, providing a theoretical basis for further standardizing and promoting the application of ERAS concept in the perioperative clinical practice of gastric cancer surgery.

Conditions

Interventions

TypeNameDescription
OTHERERAS protocolThe ERAS process mainly includes removing the urethral catheter before the recovery of anesthesia, removing the abdominal drainage tube within 3 days after surgery, removing the nasogastric feeding tu

Timeline

Start date
2024-05-01
Primary completion
2025-05-01
Completion
2025-12-01
First posted
2024-07-05
Last updated
2024-07-05

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06489288. Inclusion in this directory is not an endorsement.