Chonnam Nationl University Hwasun Hospital
Hwasun-gun, Jeollanam-do, 519-809, South Korea
NCT Number: NCT01653496
The purpose of this study is to prospectively evaluate the overall compliance to the enhanced recovery after surgery (ERAS) program in patients undergoing gastric cancer surgery.
Looking for future studies?
Notify Me18 year–70 year
All sexes
Interventional
Phase 2
Hwasun-gun, Jeollanam-do, 519-809, South Korea
The feasibility and effectiveness of ERAS program for various major surgical procedures have been well studies in the literature. However, ERAS program has not been widely accepted for patients undergoing gastric cancer surgery because of the paucity of evidence about its feasibility and efficacy. In this study, we developed ERAS program for gastric cancer surgery, based on the systemic review about perioperative cares. The main elements of ERAS program includes: 1preoperative patient education, 2)no preoperative bowel preparation, 3) provision of normal diet until the night before surgery, 4)carbohydrate rich drink 2 hrs before surgery, 5)epidural anesthesia for pain control, 6) local wound anesthetic infiltration for pain control, 7)no routine abdominal drain, 8)no naso-gastric tube insertion, 9)intraoperative antibiotics, 10)thromboprophylaxis using intermittent pneumatic compression device, 11)intraoperative normothermia using warm air blanket, 12)low oxygen supply during immediate postoperative period, 13)restrictive postoperative fluid administration, 14)early postoperative oral diet, 15)early active ambulation, 16)early removal of the urinary catheter, 17)patient education before discharge, and 18)hospital discharge based on discharge criteria.
The aim of study is to evaluate the compliance to these main elements of ERAS program in patients undergoing gastric cancer surgery.
Previously reported data about ERAS program for colon surgery reported overall compliance as about 65%. Considering that this is a single center study, we expected overall compliance rate of 70%. Therefore, the sample size of 173 patients was calculated based on this expected compliance rate, with permitted error of 95% confidence interval of 14%.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The main 18 elements of ERAS program included are described in detail in the brief summary of the study
Time frame: 90 days
Patient's compliance to the 18 main elements of ERAS program
Time frame: 90 days
Postoperative complications means any complications occured within 90 days after operation, and will be assessed based on the predefined definition and severity of postoperative complication of our institution.
Time frame: 90 days
The length of hospital stay means the duration from the operation until hospital discharge.
Time frame: 90 days
Any death related to surgery within 90 days after surgery
Chonnam National University Hospital
Other
Phase II Study Evaluating the Compliance to the Enhanced Recovery After Surgery (ERAS) Program in Patients Undergoing Gastrectomy for Gastric Carcinoma
Acronym: ERAS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07682220
Behavior, Digestive System Diseases
Harbin, Heilongjiang, China
View Trial DetailsNCT05334719
Digestive System Diseases, Digestive System Neoplasms
Minato-ku, Tokyo, Japan
View Trial DetailsNCT03030404
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Digestive System Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT03675737
Digestive System Diseases, Digestive System Neoplasms
Los Angeles, California, United States
View Trial Details