Impact of a Colorectal Enhanced Recovery Program Implementation on Clinical Outcomes and Institutional Costs

NCT03382210 | Completed DMC

• 1 other identifier: RF-2010-2322017
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Importance: The Enhanced Recovery Program (ERP) for perioperative care of the surgical patient reduces the postoperative metabolic response and organ dysfunction thereby accelerating functional recovery. Consequently, the hospital length of stay (LOS) may be reduced, with no increase in morbidity and mortality rates resulting in a potential economic benefit. Objective: To determine impact on postoperative recovery and cost-effectiveness of implementing an ERP for colorectal surgery in an Italian academic center. Design, Setting, and Participants: A prospective consecutive series of patients (N=100) undergoing elective colorectal resection completing a standardized ERP in 2013-2015 (ERP group) will be compared to patients (N=100) operated on at the same Italian University hospital in 2010-2011 (Pre-ERP group) before introducing ERP program. The exclusion criteria are: age\>80 years old, ASA score IV, tumour stage IV, and inflammatory bowel disease. Exposures: ERP for perioperative care. Main Outcomes and Measures: To evaluate the impact of colorectal ERP implementation on hospital LOS proxy of functional recovery. Secondary outcomes include: postoperative complications, 30-day readmission and mortality, protocol adherence, nursing workload, cost-effectiveness, and factors predicting prolonged hospital LOS. Patients' satisfaction in ERP group will also be prospectively evaluated.

Conditions

Colorectal Surgery; Recovery of Function; Laparoscopic Surgery

Keywords

Enhanced Recovery Program

Outcome Measures

Primary Outcomes (1)

• Postoperative Hospital Length Of Stay (LOS).

  The postoperative hospital LOS, proxy of functional recovery, is defined as the number of days from the date of surgical operation to the date of hospital. Patients in both study groups wil be discharged from the hospital upon reaching all predefined discharged criteria. For the ERP group it is estimated a 4 to 5-day hospital LOS according to the protocol, while in the traditional group an 8 to 10-day hospital stay is expected.

  Within 10 days from date of surgical operation.

Secondary Outcomes (8)

• Morbidity.

  Within 30 days from date of surgical operation.

• Mortality.

  Within 30 days from date of surgical operation.

• 30-day readmission.

  Within 30 days from date of surgical operation.

• Nursing workload evaluated by Project de Recherche en Nursing (PRN).

  From date of surgical operation to the 4th postoperative day.

• Cost-effectiveness.

  From date of preoperative counseling to 30 days from date of surgical operation.

Study Arms (2)

ERP group

A prospective series of patients (N=100) undergoing elective colorectal resection and completing a standardized enhanced recovery protocol in 2013-2015 (ERP group) at the S. Anna University Hospital in Ferrara (Italy).

Other: Enhanced recovery protocol

Pre-ERP group

A retrospective series of patients (N=100) operated on at the the S. Anna University Hospital in Ferrara (Italy) in 2009-2011 (Pre-ERP group), before the introduction of ERP methodology.

Interventions

Enhanced recovery protocol OTHER

Standardized enhanced recovery protocol including 21 perioperative items.

ERP group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective colorectal resection at the S. Anna University Hospital in Ferrara (Italy) between 2013-2015 (ERP group) and 2009-2011 (Pre ERP group)

You may qualify if:

• Patients undergoing elective colorectal resection at the S. Anna University Hospital in Ferrara (Italy)

You may not qualify if:

• age \>80 years old,
• American Society of Anesthesia (ASA) score IV,
• TNM stage IV,
• inflammatory bowel disease

Sponsors & Collaborators

• University Hospital of Ferrara: lead
• Ministero della Salute, Italy: collaborator
• Università degli Studi di Ferrara: collaborator

Related Publications (9)

• Varadhan KK, Neal KR, Dejong CH, Fearon KC, Ljungqvist O, Lobo DN. The enhanced recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal surgery: a meta-analysis of randomized controlled trials. Clin Nutr. 2010 Aug;29(4):434-40. doi: 10.1016/j.clnu.2010.01.004. Epub 2010 Jan 29.

  PMID: 20116145 BACKGROUND

• Greco M, Capretti G, Beretta L, Gemma M, Pecorelli N, Braga M. Enhanced recovery program in colorectal surgery: a meta-analysis of randomized controlled trials. World J Surg. 2014 Jun;38(6):1531-41. doi: 10.1007/s00268-013-2416-8.

  PMID: 24368573 BACKGROUND

• Braga M, Pecorelli N, Scatizzi M, Borghi F, Missana G, Radrizzani D; PeriOperative Italian Society. Enhanced Recovery Program in High-Risk Patients Undergoing Colorectal Surgery: Results from the PeriOperative Italian Society Registry. World J Surg. 2017 Mar;41(3):860-867. doi: 10.1007/s00268-016-3766-9.

  PMID: 27766398 BACKGROUND

• Adamina M, Kehlet H, Tomlinson GA, Senagore AJ, Delaney CP. Enhanced recovery pathways optimize health outcomes and resource utilization: a meta-analysis of randomized controlled trials in colorectal surgery. Surgery. 2011 Jun;149(6):830-40. doi: 10.1016/j.surg.2010.11.003. Epub 2011 Jan 14.

  PMID: 21236454 BACKGROUND

• Lee L, Mata J, Ghitulescu GA, Boutros M, Charlebois P, Stein B, Liberman AS, Fried GM, Morin N, Carli F, Latimer E, Feldman LS. Cost-effectiveness of Enhanced Recovery Versus Conventional Perioperative Management for Colorectal Surgery. Ann Surg. 2015 Dec;262(6):1026-33. doi: 10.1097/SLA.0000000000001019.

  PMID: 25371130 BACKGROUND

• Frostholm L, Fink P, Oernboel E, Christensen KS, Toft T, Olesen F, Weinman J. The uncertain consultation and patient satisfaction: the impact of patients' illness perceptions and a randomized controlled trial on the training of physicians' communication skills. Psychosom Med. 2005 Nov-Dec;67(6):897-905. doi: 10.1097/01.psy.0000188403.94327.5b.

  PMID: 16314594 BACKGROUND

• Kleefstra SM, Kool RB, Veldkamp CM, Winters-van der Meer AC, Mens MA, Blijham GH, de Haes JC. A core questionnaire for the assessment of patient satisfaction in academic hospitals in The Netherlands: development and first results in a nationwide study. Qual Saf Health Care. 2010 Oct;19(5):e24. doi: 10.1136/qshc.2008.030825. Epub 2010 Jun 24.

  PMID: 20577001 BACKGROUND

• Feo CV, Portinari M, Tsolaki E, Romagnoni G, Verri M, Camerani S, Volta CA, Mascoli F. The effect of an Enhanced Recovery Program in elective retroperitoneal abdominal aortic aneurysm repair. J Vasc Surg. 2016 Apr;63(4):888-94. doi: 10.1016/j.jvs.2015.09.060. Epub 2016 Jan 21.

  PMID: 26806521 BACKGROUND

• Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.

  PMID: 28097305 RESULT

Study Officials

• Carlo V Feo, MD

  University Hospital Ferrara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: December 22, 2017
• Study Start: January 11, 2013
• Primary Completion: December 18, 2015
• Study Completion: April 11, 2016
• Last Updated: December 22, 2017

Record last verified: 2017-12