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Enhanced Recovery After SurgeryNCT04201730

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

A study testing Enhanced Recovery After Surgery （ERAS） in people with Enhanced Recovery After Surgery and Gastrointestinal Cancer, run by Huashan Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Enhanced Recovery After Surgery （ERAS）
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
356 participants
Where
1 siteChina
Study dates
25 Dec 2019to 1 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, 200040

Other trials in China

About this study

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

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.

Being tested
Enhanced Recovery After Surgery （ERAS）
Medical subject headings
Gastrointestinal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enhanced Recovery After Surgery （ERAS）Procedure or surgery

    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.

Study groups in NCT04201730
Study groupRoleWhat they receive
ERASExperimentalPerioperative intervention with individual Enhanced Recovery After Surgery （ERAS）
Receives: Procedure: Enhanced Recovery After Surgery （ERAS）

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hospitalization Days

    Measured: Postoperative up to 2 weeks

  2. Time of getting out of bed after operation

    Measured: Postoperative 7 days

  3. The time to first flatus

    Measured: Postoperative 7 days

Secondary outcomes (2)

  1. Expenses on medical treatment, medicine and hospitalization

    Measured: On discharge, Postoperative up to 2 weeks

  2. Incidence of postoperative complications

    Measured: Postoperative 3 months、6 months、1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2019
  2. Study start25 Dec 2019
  3. Primary completion31 Dec 2020
  4. Study completion1 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
356 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04201730
Sponsor's protocol ID
KY2018-396
Status last verified
Sep 2021
First submitted
9 Dec 2019
Last updated
21 Sep 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 11222424

  • 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.

    PubMed 23708720

  • 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.

    PubMed 21468643

  • 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.

    PubMed 22011937

  • 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.

    PubMed 22673593

  • 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.

    PubMed 24379639

  • 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.

    PubMed 25228170

  • 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.

    PubMed 25801106

  • 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.

    PubMed 26290648

  • 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.

    PubMed 20717178

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced Recovery After Surgery （ERAS） in people with Enhanced Recovery After Surgery and Gastrointestinal Cancer, run by Huashan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospitalization Days (time frame: Postoperative up to 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04201730, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.

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