Compliance to ERAS After Gastric Surgery
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stomach Neoplasms |
Procedure: Enhanced recovery after surgery |
Phase 2 |
| Study Type: | Interventional |
| 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
| Estimated Enrollment: | 173 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Detailed Description:
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%.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients who are to undergo gastric cancer surgery
- ASA score < 3
- ECOG performance status 0-1
- Adequate hepatic, renal, and hematologic function
- Written informed consent
Exclusion Criteria:
- Previous abdominal operation history
- Concommitant other organ malignant disease
- Preoperative chemotherapy or radiation therapy
- Concommitant other organ resection during surgery
- Emergency operation due to bleeding or perforation
- Active underlying medical illness
- Pregnancy
Contacts and Locations| Contact: Young-Kyu Park, MD, PhD | +82-61-379-7644 | parkyk@jnu.ac.kr |
| Korea, Republic of | |
| Chonnam Nationl University Hwasun Hospital | Recruiting |
| Hwasun-gun, Jeollanam-do, Korea, Republic of, 519-809 | |
| Contact: Oh Jeong, MD +82-10-9696-3699 surgeonjeong@yahoo.co.kr | |
| Principal Investigator: Young-Kyu Park, MD, PhD | |
| Principal Investigator: | Young-Kyu Park, MD, PhD | Chonnam National University Hospital, Korea |
More Information
No publications provided
| Responsible Party: | Young Kyu Park, Professor, Department of Gastroenterologic Surgery, Chonnam National University Hospital |
| ClinicalTrials.gov Identifier: | NCT01653496 History of Changes |
| Other Study ID Numbers: | CNUHGES-001 |
| Study First Received: | July 13, 2012 |
| Last Updated: | July 27, 2012 |
| Health Authority: | Korea: Institutional Review Board |
Keywords provided by Chonnam National University Hospital:
|
Gastric cancer Perioperative care Enhanced recovery after surgery |
Multimodal rehabilitation Fast track surgery Gastrectomy |
Additional relevant MeSH terms:
|
Neoplasms Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |
ClinicalTrials.gov processed this record on May 16, 2013