Colorectal Surgery Clinical Trial
Official title:
Impact of a Colorectal Enhanced Recovery Program Implementation on Clinical Outcomes and Institutional Costs: A Prospective Cohort Study With Retrospective Control
Verified date | December 2017 |
Source | University Hospital of Ferrara |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | April 11, 2016 |
Est. primary completion date | December 18, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients undergoing elective colorectal resection at the S. Anna University Hospital in Ferrara (Italy) Exclusion Criteria: - age >80 years old, - American Society of Anesthesia (ASA) score IV, - TNM stage IV, - inflammatory bowel disease |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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University Hospital of Ferrara | Ministero della Salute, Italy, Università degli Studi di Ferrara |
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Morbidity. | Postoperative complications. | Within 30 days from date of surgical operation. | |
Secondary | Mortality. | Postoperative mortality rate. | Within 30 days from date of surgical operation. | |
Secondary | 30-day readmission. | 30-day readmission rate to the hospital. | Within 30 days from date of surgical operation. | |
Secondary | Nursing workload evaluated by Project de Recherche en Nursing (PRN). | Nursing workload for postoperative patient care. | From date of surgical operation to the 4th postoperative day. | |
Secondary | Cost-effectiveness. | Direct cost analysis. | From date of preoperative counseling to 30 days from date of surgical operation. | |
Secondary | Predictors of prolonged LOS. | Assessment of the association of different baseline characteristics, intraoperative variable and type of perioperative protocol with prolonged hospital LOS in the univariate Cox regression analysis adopting time to patients' hospital discharge as the endpoint of interest. The hospital LOS is defined as the number of days from the date of surgical operation to the date of hospital discharge. Patients in both study groups wil be discharged from the hospital upon reaching all predefined discharged criteria. The estimated hospital LOS is 4 to 5 days in ERP group and 8 to 10 days in the traditional group. | Within 10 days from date of surgical operation. | |
Secondary | ERP patients' satisfaction 1. | Patients' satisfaction in ERP group will be assessed by the Patient Satisfaction Consultation Questionnaire (PSCQ-7). Due to the retrospective nature of the control group, the questionnaire wil be submitted only to ERP group patients on the day of hospital discharge and will evaluate patients' care since the date of preoperative counseling. Preoperative conseling occurs about 30 days before the surgical operation. The estimated hospital LOS is 4 to 5 days in ERP group and 8 to 10 days in the traditional group. | Within 40 days from date of preoperative counseling. | |
Secondary | ERP patients' satisfaction 2. | Patients' satisfaction in ERP group will be assessed by Core Questionnaire Patient Satisfaction (COPS). Due to the retrospective nature of the control group, the questionnaire wil be submitted only to ERP group patients on the day of hospital discharge and will evaluate patients' care since the date of preoperative counseling. Preoperative conseling occurs about 30 days before the surgical operation. The estimated hospital LOS is 4 to 5 days in ERP group and 8 to 10 days in the traditional group. | Within 40 days from date of preoperative counseling. |
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