Compliance to ERAS After Gastric Surgery (ERAS)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study Evaluating the Compliance to the Enhanced Recovery After Surgery (ERAS) Program in Patients Undergoing Gastrectomy for Gastric Carcinoma|
- Overall compliance to the ERAS program [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]Patient's compliance to the 18 main elements of ERAS program
- Morbidity [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]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.
- Hospital stay [ Time Frame: 90 days ] [ Designated as safety issue: No ]The length of hospital stay means the duration from the operation until hospital discharge.
- Mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]Any death related to surgery within 90 days after surgery
|Study Start Date:||July 2012|
|Study Completion Date:||February 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Experimental: Enhanced recovery after surgery
Patients who receive ERAS program after gastric cancer surgery
Procedure: Enhanced recovery after surgery
The main 18 elements of ERAS program included are described in detail in the brief summary of the study
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%.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01653496
|Korea, Republic of|
|Chonnam Nationl University Hwasun Hospital|
|Hwasun-gun, Jeollanam-do, Korea, Republic of, 519-809|
|Principal Investigator:||Young-Kyu Park, MD, PhD||Chonnam National University Hospital, Korea|