Effect of Enhanced Recovery After Surgery (ERAS) on C-reactive and Visceral Proteins (ERASAG)

January 27, 2015 updated by: The First Hospital of Jilin University

Effect of Enhanced Recovery After Surgery (ERAS) on C-reactive and Visceral Proteins in Patients With Advanced Gastric Cancer

The investigators designed a prospective randomized, controlled clinical trial then recruited 149 consecutive advanced gastric cancer patients. Further divided into a ERAS group (n=73) and a conventional pathway group (n=76). Surgical technique in both groups was same laparoscopic-assisted gastrectomy with D2 lymphadenectomy. Compared outcomes included clinical parameters and serum indicators.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Enhanced recovery after surgery combined with laparoscopic-assisted gastrectomy was successfully carried out in this study. Recovery parameters such as the length of time to return to normal diet,mean hospital stay (d) were recorded.

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Not Applicable

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18-75 years old
  2. Diagnosis confirmed by the endoscopic biopsy and total-body CT scan
  3. No history of the chronic renal disease ,chronic liver disease, cardiopulmonary dysfunction, ASA score≦3
  4. No neoadjuvant chemotherapy and radiotherapy
  5. No digestive obstruction and distant metastasis

Exclusion Criteria:

  1. Conversion to open gastrectomy
  2. A large amount of bleeding leading(>500ml)
  3. Patients withdrew their consent

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ERAS group
ERAS protocols
Procedure: ERAS protocols
Normal meal allowed until 6 h before surgery and Carbohydrate drink until 2 h before surgery
Procedure: ERAS protocols
No bowel preparation
Procedure: ERAS protocols
No nasogastric placement; if used, remove on the 1st postoperative day
Procedure: ERAS protocols
Vasoactive drugs used if need be
Procedure: ERAS protocols
Temperature management
Procedure: ERAS protocols
Intra-abdominal drains not to be used
Procedure: ERAS protocols
Intraperitoneal Ropivicaine infusion
Procedure: ERAS protocols

On the 1st postoperative day Nasogastric catheter removed /Urinary catheter removed.

Oral non-opioid analgesia/Drinking 0.5L liquid. Active mobilisation

Procedure: ERAS protocols
On the 2nd postoperative day：Drains removed Oral diet was initiated
Procedure: ERAS protocols
3-4th postoperative day： Stop oral non opioid analgesia
Procedure: ERAS protocols
On the5-6th postoperative day Check discharge criteria
Other: conventional pathway group
using conventional pathway
Procedure: conventional pathway group
No solid foods at dinner before surgery and no liquids 12 h before surgery. Routine bowel preparation Nasogastric placement on the morning of surgery
Procedure: conventional pathway group
Routine use of anesthesia medicine. Standard 5-trocar laparoscopy-assisted procedure. I.V. fluids not restricted (Ringer's lactate 20 ml/kg in the first hour, then at the rate of 10-12 ml/kg/h) Routine use of abdominal drainage tubes and placement of catheters.
Procedure: conventional pathway group
1st postoperative day: Keep Nasogastric catheter Removal of urinary catheter Opioid analgesic by intramuscular injection Parenteral nutrition until flatus. I.V. fluids not restricted Mobilization in bed
Procedure: conventional pathway group
2nd postoperative day Patient is advised to get out of bed until 24-48h after surgery
Procedure: conventional pathway group
3-4th postoperative day： Remove nasogastric tube after flatus Oral liquids started. Encouraged to walk in the ward.
Procedure: conventional pathway group

5-6th postoperative day：Oral diet was changed from liquids to semi-fluids and normal food.

Drains removed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compartition of postoperative hospital stay
Time Frame: up to 30 days after the operation
up to 30 days after the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in C-Reactive Protein( CRP) and visceral proteins level
Time Frame: baseline and 5 days
1day before and 1-5days after operation
baseline and 5 days

Collaborators and Investigators

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

Sponsor

The First Hospital of Jilin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

January 17, 2015

First Submitted That Met QC Criteria

January 27, 2015

First Posted (Estimate)

January 28, 2015

Study Record Updates

Last Update Posted (Estimate)

January 28, 2015

Last Update Submitted That Met QC Criteria

January 27, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-212

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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