Clinical trial NCT01653496: Compliance to ERAS After Gastric Surgery
Official title: Phase II Study Evaluating the Compliance to the Enhanced Recovery After Surgery (ERAS) Program in Patients Undergoing Gastrectomy for Gastric Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stomach Neoplasms
Keywords: Gastric cancer
Perioperative care
Enhanced recovery after surgery
Multimodal rehabilitation
Fast track surgery
Gastrectomy
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
First posted: 2012-07-31
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 criteria: 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

Primary outcomes:
measure: Overall compliance to the ERAS program
timeFrame: 90 days
Secondary outcomes:
measure: Morbidity
timeFrame: 90 days
measure: Hospital stay
timeFrame: 90 days
measure: Mortality
timeFrame: 90 days
Other outcomes:
Locations:
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam Nationl University Hwasun Hospital
state: Jeollanam-do
Study officials:
affiliation: Chonnam National University Hospital, Korea
name: Young-Kyu Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jung MR, Ryu SY, Park YK, Jeong O. Compliance with an Enhanced Recovery After a Surgery Program for Patients Undergoing Gastrectomy for Gastric Carcinoma: A Phase 2 Study. Ann Surg Oncol. 2018 Aug;25(8):2366-2373. doi: 10.1245/s10434-018-6524-4. Epub 2018 May 22.