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

NCT ID: NCT02348229

Last Updated: 2015-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-10-31

Brief Summary

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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

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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

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ERAS group

ERAS protocols

Group Type EXPERIMENTAL

ERAS protocols

Intervention Type PROCEDURE

Normal meal allowed until 6 h before surgery and Carbohydrate drink until 2 h before surgery

ERAS protocols

Intervention Type PROCEDURE

No bowel preparation

ERAS protocols

Intervention Type PROCEDURE

No nasogastric placement; if used, remove on the 1st postoperative day

ERAS protocols

Intervention Type PROCEDURE

Vasoactive drugs used if need be

ERAS protocols

Intervention Type PROCEDURE

Temperature management

ERAS protocols

Intervention Type PROCEDURE

Intra-abdominal drains not to be used

ERAS protocols

Intervention Type PROCEDURE

Intraperitoneal Ropivicaine infusion

ERAS protocols

Intervention Type PROCEDURE

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

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

ERAS protocols

Intervention Type PROCEDURE

On the 2nd postoperative day:Drains removed Oral diet was initiated

ERAS protocols

Intervention Type PROCEDURE

3-4th postoperative day: Stop oral non opioid analgesia

ERAS protocols

Intervention Type PROCEDURE

On the5-6th postoperative day Check discharge criteria

conventional pathway group

using conventional pathway

Group Type OTHER

conventional pathway group

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

2nd postoperative day Patient is advised to get out of bed until 24-48h after surgery

conventional pathway group

Intervention Type PROCEDURE

3-4th postoperative day: Remove nasogastric tube after flatus Oral liquids started. Encouraged to walk in the ward.

conventional pathway group

Intervention Type PROCEDURE

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

Drains removed

Interventions

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ERAS protocols

Normal meal allowed until 6 h before surgery and Carbohydrate drink until 2 h before surgery

Intervention Type PROCEDURE

ERAS protocols

No bowel preparation

Intervention Type PROCEDURE

ERAS protocols

No nasogastric placement; if used, remove on the 1st postoperative day

Intervention Type PROCEDURE

ERAS protocols

Vasoactive drugs used if need be

Intervention Type PROCEDURE

ERAS protocols

Temperature management

Intervention Type PROCEDURE

ERAS protocols

Intra-abdominal drains not to be used

Intervention Type PROCEDURE

ERAS protocols

Intraperitoneal Ropivicaine infusion

Intervention Type PROCEDURE

ERAS protocols

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

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

Intervention Type PROCEDURE

ERAS protocols

On the 2nd postoperative day:Drains removed Oral diet was initiated

Intervention Type PROCEDURE

ERAS protocols

3-4th postoperative day: Stop oral non opioid analgesia

Intervention Type PROCEDURE

ERAS protocols

On the5-6th postoperative day Check discharge criteria

Intervention Type 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

Intervention Type 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.

Intervention Type 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

Intervention Type PROCEDURE

conventional pathway group

2nd postoperative day Patient is advised to get out of bed until 24-48h after surgery

Intervention Type PROCEDURE

conventional pathway group

3-4th postoperative day: Remove nasogastric tube after flatus Oral liquids started. Encouraged to walk in the ward.

Intervention Type PROCEDURE

conventional pathway group

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

Drains removed

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Hospital of Jilin University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Quan Wang, Doctor

Role: STUDY_DIRECTOR

The First Hospital of Jilin University

References

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Mingjie X, Luyao Z, Ze T, YinQuan Z, Quan W. Laparoscopic Radical Gastrectomy for Resectable Advanced Gastric Cancer Within Enhanced Recovery Programs: A Prospective Randomized Controlled Trial. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):959-964. doi: 10.1089/lap.2016.0057. Epub 2016 Nov 22.

Reference Type DERIVED
PMID: 27875094 (View on PubMed)

Other Identifiers

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2013-212

Identifier Type: -

Identifier Source: org_study_id

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