Back to results

Study on the Efficacy and Safety of Enhanced Recovery After Surgery （ERAS）in Gastrointestinal Cancer

Primary Purpose

Enhanced Recovery After Surgery, Gastrointestinal Cancer

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Enhanced Recovery After Surgery （ERAS）

About this trial

This is an interventional treatment trial for Enhanced Recovery After Surgery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Sign the informed consent
Preoperative pathology confirmed gastric cancer or colorectal cancer
Age: 18-70 years, men or women
According to NCCN guidelines, it is not Stage IV tumor
Perform radical gastrectomy or radical colon cancer surgery (CME) or radical rectal cancer surgery (TME);
ASA I-III
Receive no radiotherapy or chemotherapy before operation
The subjects can describe the symptoms objectively and keep the follow-up plan

Exclusion Criteria:

Preoperative pathology confirmed no gastric cancer / no colorectal cancer (such as rectal neuroendocrine tumor, lymphoma, etc.)
Stage IV or Radical resection can't be performed
Emergency operation
Can't cooperate with clinical data collection
General condition is intolerable to operation
Serious diseases, including heart function ≥ level II, respiratory function insufficiency, liver and kidney function insufficiency, and blood system diseases
Patients participate in other clinical trials at the same time
Pregnant or perinatal women
Other malignant tumors
History of mental illness
Had a history of severe trauma within 4 weeks before admission
Less than 6 months after other level 4 operations

Sites / Locations

Huashan Hospital Affiliated to Fudan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ERAS

Arm Description

Perioperative intervention with individual Enhanced Recovery After Surgery （ERAS）

Outcomes

Primary Outcome Measures

Hospitalization Days

Time of getting out of bed after operation

The time to first flatus

Secondary Outcome Measures

Expenses on medical treatment, medicine and hospitalization

Incidence of postoperative complications

Full Information

NCT ID

NCT04201730

First Posted

December 9, 2019

Last Updated

September 19, 2021

Sponsor

Huashan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04201730

Brief Title

Study on the Efficacy and Safety of Enhanced Recovery After Surgery （ERAS）in Gastrointestinal Cancer

Official Title

A Single Center, Open, Randomized Clinical Trial：Study on the Efficacy and Safety of Enhanced Recovery After Surgery （ERAS）in Gastrointestinal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

December 25, 2019 (Actual)

Primary Completion Date

December 31, 2020 (Actual)

Study Completion Date

June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Huashan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

At present, there are more and more reports about enhanced recovery after surgery（ERAS）in China, but there is no ERAS treatment standard for gastrointestinal cancer, and there are many factors limiting the development of ERAS. In recent years, due to the development of minimally invasive technology, the establishment of evidence-based medicine model and the development of MDT, it makes a good solid foundation for the clinical application of ERAS. The implementation of ERAS requires the cooperation of surgeons, anesthesia management, nursing, rehabilitation and other teams. As an individualized treatment mode, ERAS focuses on the optimization of treatment for different individuals in order to acquire the best benefit of patients. Therefore, the concept of ERAS is still in the process of continuous improvement and development in China, hoping to explore the Chinese ERAS clinical pathway for gastrointestinal cancer. The purpose of this study is to optimize the clinical pathway of ERAS in the perioperative period of gastrointestinal cancer, and to evaluate the effectiveness and safety of ERAS in gastrointestinal cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Enhanced Recovery After Surgery, Gastrointestinal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

356 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ERAS

Arm Type

Experimental

Arm Description

Perioperative intervention with individual Enhanced Recovery After Surgery （ERAS）

Intervention Type

Procedure

Intervention Name(s)

Enhanced Recovery After Surgery （ERAS）

Intervention Description

Preoperative education，Preoperative nutritional support，Preoperative bowel preparation，Preventative applying of antibiotics，Intraoperative warming，Goal-directed fluid therapy，Postoperative analgesia，Postoperative diet, drainage and activity management，Prevention of deep vein thrombosis.

Primary Outcome Measure Information:

Title

Hospitalization Days

Time Frame

Postoperative up to 2 weeks

Title

Time of getting out of bed after operation

Time Frame

Postoperative 7 days

Title

The time to first flatus

Time Frame

Postoperative 7 days

Secondary Outcome Measure Information:

Title

Expenses on medical treatment, medicine and hospitalization

Time Frame

On discharge, Postoperative up to 2 weeks

Title

Incidence of postoperative complications

Time Frame

Postoperative 3 months、6 months、1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Sign the informed consent Preoperative pathology confirmed gastric cancer or colorectal cancer Age: 18-70 years, men or women According to NCCN guidelines, it is not Stage IV tumor Perform radical gastrectomy or radical colon cancer surgery (CME) or radical rectal cancer surgery (TME); ASA I-III Receive no radiotherapy or chemotherapy before operation The subjects can describe the symptoms objectively and keep the follow-up plan Exclusion Criteria: Preoperative pathology confirmed no gastric cancer / no colorectal cancer (such as rectal neuroendocrine tumor, lymphoma, etc.) Stage IV or Radical resection can't be performed Emergency operation Can't cooperate with clinical data collection General condition is intolerable to operation Serious diseases, including heart function ≥ level II, respiratory function insufficiency, liver and kidney function insufficiency, and blood system diseases Patients participate in other clinical trials at the same time Pregnant or perinatal women Other malignant tumors History of mental illness Had a history of severe trauma within 4 weeks before admission Less than 6 months after other level 4 operations

Facility Information:

Facility Name

Huashan Hospital Affiliated to Fudan University

City

Shanghai

ZIP/Postal Code

200040

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

11222424

Citation

Wilmore DW, Kehlet H. Management of patients in fast track surgery. BMJ. 2001 Feb 24;322(7284):473-6. doi: 10.1136/bmj.322.7284.473. No abstract available.

Results Reference

result

PubMed Identifier

23708720

Citation

Lee SM, Kang SB, Jang JH, Park JS, Hong S, Lee TG, Ahn S. Early rehabilitation versus conventional care after laparoscopic rectal surgery: a prospective, randomized, controlled trial. Surg Endosc. 2013 Oct;27(10):3902-9. doi: 10.1007/s00464-013-3006-4. Epub 2013 May 25.

Results Reference

result

PubMed Identifier

21468643

Citation

Kehlet H. Fast-track surgery-an update on physiological care principles to enhance recovery. Langenbecks Arch Surg. 2011 Jun;396(5):585-90. doi: 10.1007/s00423-011-0790-y. Epub 2011 Apr 6.

Results Reference

result

PubMed Identifier

22011937

Citation

Aarts MA, Okrainec A, Glicksman A, Pearsall E, Victor JC, McLeod RS. Adoption of enhanced recovery after surgery (ERAS) strategies for colorectal surgery at academic teaching hospitals and impact on total length of hospital stay. Surg Endosc. 2012 Feb;26(2):442-50. doi: 10.1007/s00464-011-1897-5. Epub 2011 Oct 20.

Results Reference

result

PubMed Identifier

22673593

Citation

Jie B, Jiang ZM, Nolan MT, Zhu SN, Yu K, Kondrup J. Impact of preoperative nutritional support on clinical outcome in abdominal surgical patients at nutritional risk. Nutrition. 2012 Oct;28(10):1022-7. doi: 10.1016/j.nut.2012.01.017. Epub 2012 Jun 5.

Results Reference

result

PubMed Identifier

24379639

Citation

Li P, Fang F, Cai JX, Tang D, Li QG, Wang DR. Fast-track rehabilitation vs conventional care in laparoscopic colorectal resection for colorectal malignancy: a meta-analysis. World J Gastroenterol. 2013 Dec 21;19(47):9119-26. doi: 10.3748/wjg.v19.i47.9119.

Results Reference

result

PubMed Identifier

25228170

Citation

Li YJ, Huo TT, Xing J, An JZ, Han ZY, Liu XN, Zhao QC. Meta-analysis of efficacy and safety of fast-track surgery in gastrectomy for gastric cancer. World J Surg. 2014 Dec;38(12):3142-51. doi: 10.1007/s00268-014-2690-0.

Results Reference

result

PubMed Identifier

25801106

Citation

Spanjersberg WR, van Sambeeck JD, Bremers A, Rosman C, van Laarhoven CJ. Systematic review and meta-analysis for laparoscopic versus open colon surgery with or without an ERAS programme. Surg Endosc. 2015 Dec;29(12):3443-53. doi: 10.1007/s00464-015-4148-3. Epub 2015 Mar 24.

Results Reference

result

PubMed Identifier

26290648

Citation

Ni TG, Yang HT, Zhang H, Meng HP, Li B. Enhanced recovery after surgery programs in patients undergoing hepatectomy: A meta-analysis. World J Gastroenterol. 2015 Aug 14;21(30):9209-16. doi: 10.3748/wjg.v21.i30.9209.

Results Reference

result

PubMed Identifier

20717178

Citation

Sammour T, Zargar-Shoshtari K, Bhat A, Kahokehr A, Hill AG. A programme of Enhanced Recovery After Surgery (ERAS) is a cost-effective intervention in elective colonic surgery. N Z Med J. 2010 Jul 30;123(1319):61-70.

Results Reference

result

Learn more about this trial

Study on the Efficacy and Safety of Enhanced Recovery After Surgery （ERAS）in Gastrointestinal Cancer

We'll reach out to this number within 24 hrs