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Trials / Completed

CompletedNCT02348229

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
149 (actual)
Sponsor
The First Hospital of Jilin University · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREERAS protocolsNormal meal allowed until 6 h before surgery and Carbohydrate drink until 2 h before surgery
PROCEDUREERAS protocolsNo bowel preparation
PROCEDUREERAS protocolsNo nasogastric placement; if used, remove on the 1st postoperative day
PROCEDUREERAS protocolsVasoactive drugs used if need be
PROCEDUREERAS protocolsTemperature management
PROCEDUREERAS protocolsIntra-abdominal drains not to be used
PROCEDUREERAS protocolsIntraperitoneal Ropivicaine infusion
PROCEDUREERAS protocolsOn the 1st postoperative day Nasogastric catheter removed /Urinary catheter removed. Oral non-opioid analgesia/Drinking 0.5L liquid. Active mobilisation
PROCEDUREERAS protocolsOn the 2nd postoperative day:Drains removed Oral diet was initiated
PROCEDUREERAS protocols3-4th postoperative day: Stop oral non opioid analgesia
PROCEDUREERAS protocolsOn the5-6th postoperative day Check discharge criteria
PROCEDUREconventional pathway groupNo solid foods at dinner before surgery and no liquids 12 h before surgery. Routine bowel preparation Nasogastric placement on the morning of surgery
PROCEDUREconventional pathway groupRoutine 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.
PROCEDUREconventional pathway group1st 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
PROCEDUREconventional pathway group2nd postoperative day Patient is advised to get out of bed until 24-48h after surgery
PROCEDUREconventional pathway group3-4th postoperative day: Remove nasogastric tube after flatus Oral liquids started. Encouraged to walk in the ward.
PROCEDUREconventional pathway group5-6th postoperative day:Oral diet was changed from liquids to semi-fluids and normal food. Drains removed

Timeline

Start date
2013-09-01
Primary completion
2014-09-01
Completion
2014-10-01
First posted
2015-01-28
Last updated
2015-01-28

Source: ClinicalTrials.gov record NCT02348229. Inclusion in this directory is not an endorsement.