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

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Procedure: ERAS protocols
* Procedure: ERAS protocols
* Procedure: ERAS protocols
* Procedure: ERAS protocols
* Procedure: ERAS protocols
* Procedure: ERAS protocols
* Procedure: ERAS protocols
* Procedure: ERAS protocols
* Procedure: ERAS protocols
* Procedure: ERAS protocols
* Procedure: ERAS protocols
* Procedure: conventional pathway group
* Procedure: conventional pathway group
* Procedure: conventional pathway group
* Procedure: conventional pathway group
* Procedure: conventional pathway group
* Procedure: conventional pathway group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-75 years old Diagnosis confirmed by the endoscopic biopsy and total-body CT scan No history of the chronic renal disease ,chronic liver disease, cardiopulmonary dysfunction, ASA score≦3 No neoadjuvant chemotherapy and radiotherapy No digestive obstruction and distant metastasis Exclusion Criteria: Conversion to open gastrectomy A large amount of bleeding leading(>500ml) Patients withdrew their consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERAS group<br>ERAS protocols | Procedure: ERAS protocols<br>* Normal meal allowed until 6 h before surgery and Carbohydrate drink until 2 h before surgery<br>Procedure: ERAS protocols<br>* No bowel preparation<br>Procedure: ERAS protocols<br>* No nasogastric placement; if used, remove on the 1st postoperative day<br>Procedure: ERAS protocols<br>* Vasoactive drugs used if need be<br>Procedure: ERAS protocols<br>* Temperature management<br>Procedure: ERAS protocols<br>* Intra-abdominal drains not to be used<br>Procedure: ERAS protocols<br>* Intraperitoneal Ropivicaine infusion<br>Procedure: ERAS protocols<br>* On the 1st postoperative day Nasogastric catheter removed /Urinary catheter removed. Oral non-opioid analgesia/Drinking 0.5L liquid. Active mobilisation<br>Procedure: ERAS protocols<br>* On the 2nd postoperative day：Drains removed Oral diet was initiated<br>Procedure: ERAS protocols<br>* 3-4th postoperative day： Stop oral non opioid analgesia<br>Procedure: ERAS protocols<br>* On the5-6th postoperative day Check discharge criteria<br>|
| Other: conventional pathway group<br>using conventional pathway | Procedure: conventional pathway group<br>* No solid foods at dinner before surgery and no liquids 12 h before surgery. Routine bowel preparation Nasogastric placement on the morning of surgery<br>Procedure: conventional pathway group<br>* 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.<br>Procedure: conventional pathway group<br>* 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<br>Procedure: conventional pathway group<br>* 2nd postoperative day Patient is advised to get out of bed until 24-48h after surgery<br>Procedure: conventional pathway group<br>* 3-4th postoperative day： Remove nasogastric tube after flatus Oral liquids started. Encouraged to walk in the ward.<br>Procedure: conventional pathway group<br>* 5-6th postoperative day：Oral diet was changed from liquids to semi-fluids and normal food. Drains removed<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compartition of postoperative hospital stay |  | 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 | 1day before and 1-5days after operation | baseline and 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Enhanced recovery after surgery, laparoscopic gastrectomy, advanced gastric cancer, C-reactive,visceral proteins