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

Gastric Cancer Clinical Trial

— ERASAG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02348229
• Other study ID #: 2013-212
• Status: Completed
• Phase: N/A
• First received: January 17, 2015
• Last updated: January 27, 2015
• Start date: September 2013
• Est. completion date: October 2014

Study information

• Verified date: January 2015
• Source: First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Hospital of Jilin University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compartition of postoperative hospital stay		up to 30 days after the operation	No
Secondary	Change from baseline in C-Reactive Protein( CRP) and visceral proteins level	1day before and 1-5days after operation	baseline and 5 days	No