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

NCT04201730 | Completed

• 1 other identifier: KY2018-396
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

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.

Conditions

Enhanced Recovery After Surgery; Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (3)

• Hospitalization Days

  Postoperative up to 2 weeks

• Time of getting out of bed after operation

  Postoperative 7 days

• The time to first flatus

  Postoperative 7 days

Secondary Outcomes (2)

• Expenses on medical treatment, medicine and hospitalization

  On discharge, Postoperative up to 2 weeks

• Incidence of postoperative complications

  Postoperative 3 months、6 months、1 year

Study Arms (1)

ERAS

EXPERIMENTAL

Perioperative intervention with individual Enhanced Recovery After Surgery （ERAS）

Procedure: Enhanced Recovery After Surgery （ERAS）

Interventions

Enhanced Recovery After Surgery （ERAS） PROCEDURE

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.

ERAS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital Affiliated to Fudan University

Shanghai, 200040, China

Location

Related Publications (10)

• 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.

  PMID: 11222424 RESULT

• 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.

  PMID: 23708720 RESULT

• 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.

  PMID: 21468643 RESULT

• 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.

  PMID: 22011937 RESULT

• 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.

  PMID: 22673593 RESULT

• 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.

  PMID: 24379639 RESULT

• 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.

  PMID: 25228170 RESULT

• 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.

  PMID: 25801106 RESULT

• 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.

  PMID: 26290648 RESULT

• 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.

  PMID: 20717178 RESULT

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Enhanced Recovery After Surgery

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 17, 2019
• Study Start: December 25, 2019
• Primary Completion: December 31, 2020
• Study Completion: June 1, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)