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

Gastrointestinal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04201730
• Other study ID #: KY2018-396
• Status: Completed
• Phase: N/A
• Start date: December 25, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: September 2021
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: June 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Enhanced Recovery After Surgery
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

Procedure:
• Enhanced Recovery After Surgery (ERAS)
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.

Locations

Country	Name	City	State
China	Huashan Hospital Affiliated to Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

References & Publications (10)

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( — View 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. — View 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. Review. — View 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. Ep — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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 — View Citation

Wilmore DW, Kehlet H. Management of patients in fast track surgery. BMJ. 2001 Feb 24;322(7284):473-6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization Days		Postoperative up to 2 weeks
Primary	Time of getting out of bed after operation		Postoperative 7 days
Primary	The time to first flatus		Postoperative 7 days
Secondary	Expenses on medical treatment, medicine and hospitalization		On discharge, Postoperative up to 2 weeks
Secondary	Incidence of postoperative complications		Postoperative 3 months?6 months?1 year