The Effect of Enhanced Recovery After Surgery (ERAS) in Gastric Cancer Surgery

February 23, 2024 updated by: National Taiwan University Hospital
The investigators aimed to clarify the clinical relevance of the ERAS protocol by evaluating the perioperative course in patients undergoing laparoscopic gastric cancer surgery.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Gastric cancer is 7th common malignant disease in Taiwan, accounting for 3000 new cases per year. The main treatment of gastric cancer is radical gastrectomy and lymph nodes dissection, which is associated with 13.0~46 % of surgical morbidities. To minimize the surgical morbidities and enhance patients' recovery, perioperative management is mandatory. Enhanced Recovery After Surgery (ERAS) is a multimodal, multidisciplinary approach to the care of the surgical patient. ERAS process implementation involves a team consisting of surgeons, anesthetists, an ERAS coordinator, and staff from units that care for the surgical patient. The main elements of ERAS include carbohydrate loading before surgery, minimally invasive approaches, balanced management of intravenous fluids, multimodal pain management, early mobilization, and early oral feeding, etc. Some prospective studies have shown its effectiveness in reduce surgical morbidity and hospital stay in colorectal surgery. In Taiwan, there was only limited report to study the use of ERAS in gastric cancer surgery. The investigators would like to integrate these perioperative interventions into the ERAS program, and test its effectiveness in gastric cancer patients undergoing radical gastrectomy at NTUH.

Study Type

Interventional

Enrollment (Estimated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pathological confirmed as gastric adenocarcinoma;
  • Gastric cancer patients who will undergo subtotal gastrectomy.

Exclusion Criteria:

  • Advanced gastric cancer with gastric outlet obstruction;
  • Epidural catheter placement contraindicated or inexecutable;
  • Have other cancers that have received chemotherapy or radiation therapy;
  • Coagulation abnormalities;
  • Pregnancy;
  • Severe dysfunction of major organs (e.g., heart failure, chronic obstructive pulmonary disease, liver cirrhosis, end-stage renal disease)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm E
  1. Preoperative preparation: shorten the fasting time, take a small amount of sugar water two hours before the surgery, and reduce excessive bowel preparation.
  2. Intraoperative care: multi-model analgesia (mainly epidural analgesia), sleep depth monitoring, warm air blanket to avoid hypothermia.
  3. Postoperative care: focus on pain relief methods (such as oral analgesics, patient-controlled epidural analgesia), early postoperative feeding (try drinking water on the first day after surgery, liquid diet on the second day, and soft diet on the third day), early removal of invasive tubes such as nasogastric tubes, intravenous catheters, and urinary catheters, and medication to prevent postoperative nausea and vomiting.
Procedure: ERAS
  1. Preoperative preparation: shorten the fasting time, take a small amount of sugar water two hours before the surgery, and reduce excessive bowel preparation.
  2. Intraoperative care: multi-model analgesia (mainly epidural analgesia), sleep depth monitoring, warm air blanket to avoid hypothermia.
  3. Postoperative care: focus on pain relief methods (such as oral analgesics, patient-controlled epidural analgesia), early postoperative feeding (try drinking water on the first day after surgery, liquid diet on the second day, and soft diet on the third day), early removal of invasive tubes such as nasogastric tubes, intravenous catheters, and urinary catheters, and medication to prevent postoperative nausea and vomiting.
Placebo Comparator: Arm H
  1. Preoperative preparation: overnight fasting preparation, bowel preparation.
  2. Intraoperative care: traditional pain care (intravenous analgesics), sleep depth monitoring, warm air blanket, central venous pressure and body water monitoring indicators, traditional muscle tension relaxation treatment and the use of health insurance antagonist drugs (Neostigmine).
  3. Postoperative care: patient-controlled intravenous drip for postoperative pain relief, oral feeing (rice porridge) on the postoperative day 5, and according to the progression of patient condition, step by step to removal of invasive tubes such as nasogastric tubes, intravenous catheters, and urinary catheters.
Procedure: Conventional care
  1. Preoperative preparation: overnight fasting preparation, bowel preparation.
  2. Intraoperative care: traditional pain care (intravenous analgesics), sleep depth monitoring, warm air blanket, central venous pressure and body water monitoring indicators, traditional muscle tension relaxation treatment and the use of health insurance antagonist drugs (Neostigmine).
  3. Postoperative care: patient-controlled intravenous drip for postoperative pain relief, oral feeing (rice porridge) on the postoperative day 5, and according to the progression of patient condition, step by step to removal of invasive tubes such as nasogastric tubes, intravenous catheters, and urinary catheters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: From date of admission until the date of discharge, assessed up to 2 weeks.
When patient discharge.
From date of admission until the date of discharge, assessed up to 2 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rates
Time Frame: 28 days
The complication rates means if there are any complications occur.
28 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmission rates
Time Frame: within 28 days
when the patient is readmitted to the hospital
within 28 days
costs of hospitalization
Time Frame: From date of admission until the date of discharge, assessed up to 2 weeks.
Total medical expenses incurred during the admission period.
From date of admission until the date of discharge, assessed up to 2 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2018

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

October 16, 2023

First Submitted That Met QC Criteria

January 14, 2024

First Posted (Actual)

January 18, 2024

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201809008RINC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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