Effects of Implementing an ERAS Protocol

NCT06010225 | Completed DMC

• 1 other identifier: DRCiptoMGH
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Successful colorectal surgery is determined based on postoperative mortality and morbidity rates, complication rates, and cost-effectiveness. One of the methods to obtain an excellent postoperative outcome is the Enhanced Recovery After Surgery (ERAS) protocol. This study aims to see the effects of implementing an ERAS protocol in colorectal surgery patients. Methods: Eighty-four patients who underwent elective colorectal surgery at National Tertiary-level Hospital were included between January 2021 and July 2022. Patients were then placed into ERAS and control groups according to the criteria. The Patients in the ERAS group underwent a customized 18-component ERAS protocol and were assessed for adherence. Postoperatively, both groups were monitored for up to 30 days and assessed for complications and readmission. The investigators then analyzed the length of stay and total patient costs in both groups.

Conditions

Enhanced Recovery After Surgery (ERAS) Protocol; Colorectal Surgery; Effectivity; Colorectal Neoplasms; Colorectal Cancer

Keywords

Enhanced Recovery After Surgery (ERAS) protocol; Outcome; colorectal surgery

Outcome Measures

Primary Outcomes (4)

• length of hospitalization

  The length of hospitalization was calculated from the day of admission to the hospital ward until the discharge

  day 1 until day 30

• postoperative complications

  Postoperative complications were defined as infection on the surgical site or systemic infection, wound dehiscence, and other complications found after surgery

  day 1 until day 30

• readmission rate

  The readmission rate was calculated from discharge to one month after surgery.

  day 1 until day 30

• Total medical costs

  Total medical costs were calculated based on direct medical costs recorded in the hospital billing data. The currency was converted from Indonesian Rupiah (IDR) to US dollars (USD) based on the September 1, 2022, conversion rate of USD 1 = IDR 14,200.

  day 1 until day 30

Secondary Outcomes (1)

• adherence to the ERAS protocols

  day 1 until day 30

Study Arms (2)

ERAS group

Patients who met the inclusion criteria and consented were assigned to the ERAS group

control group

Patients who met the inclusion criteria and did not consent were assigned to the ERAS group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Colorectal cancer patients undergoing surgery at Dr. Cipto Mangunkusumo General Hospital

You may qualify if:

• maximum of two different comorbidities
• body mass index above 18.5 kg/m2
• ASA below 2

You may not qualify if:

• More than 2 comorbidities
• Refused to take part in the research

Sponsors & Collaborators

• Ridho Ardhi Syaiful: lead

Study Sites (1)

Dr. Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, 10440, Indonesia

Location

Related Publications (7)

• Andreoni B, Chiappa A, Bertani E, Bellomi M, Orecchia R, Zampino M, Fazio N, Venturino M, Orsi F, Sonzogni A, Pace U, Monfardini L. Surgical outcomes for colon and rectal cancer over a decade: results from a consecutive monocentric experience in 902 unselected patients. World J Surg Oncol. 2007 Jul 4;5:73. doi: 10.1186/1477-7819-5-73.

  PMID: 17610720 BACKGROUND

• Tevis SE, Kennedy GD. Postoperative Complications: Looking Forward to a Safer Future. Clin Colon Rectal Surg. 2016 Sep;29(3):246-52. doi: 10.1055/s-0036-1584501.

  PMID: 27582650 BACKGROUND

• Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

  PMID: 30207593 BACKGROUND

• Alves A, Panis Y, Mathieu P, Mantion G, Kwiatkowski F, Slim K; Association Francaise de Chirurgie. Postoperative mortality and morbidity in French patients undergoing colorectal surgery: results of a prospective multicenter study. Arch Surg. 2005 Mar;140(3):278-83, discussion 284. doi: 10.1001/archsurg.140.3.278.

  PMID: 15781793 BACKGROUND

• Tan JKH, Ang JJ, Chan DKH. Enhanced recovery program versus conventional care after colorectal surgery in the geriatric population: a systematic review and meta-analysis. Surg Endosc. 2021 Jun;35(6):3166-3174. doi: 10.1007/s00464-020-07673-7. Epub 2020 May 28.

  PMID: 32468264 BACKGROUND

• Miller TE, Thacker JK, White WD, Mantyh C, Migaly J, Jin J, Roche AM, Eisenstein EL, Edwards R, Anstrom KJ, Moon RE, Gan TJ; Enhanced Recovery Study Group. Reduced length of hospital stay in colorectal surgery after implementation of an enhanced recovery protocol. Anesth Analg. 2014 May;118(5):1052-61. doi: 10.1213/ANE.0000000000000206.

  PMID: 24781574 BACKGROUND

• Li L, Jin J, Min S, Liu D, Liu L. Compliance with the enhanced recovery after surgery protocol and prognosis after colorectal cancer surgery: A prospective cohort study. Oncotarget. 2017 Jun 22;8(32):53531-53541. doi: 10.18632/oncotarget.18602. eCollection 2017 Aug 8.

  PMID: 28881829 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor, Digestive Surgery

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 24, 2023
• Study Start: May 1, 2020
• Primary Completion: January 10, 2022
• Study Completion: May 1, 2023
• Last Updated: August 24, 2023

Record last verified: 2023-08

Locations

ID (1)