Colorectal Surgery Clinical Trial
Official title:
Enhanced Recovery Program in Laparoscopic Colorectal Surgery: an Observational Controlled Trial
NCT number | NCT04378465 |
Other study ID # | 52-2011 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 11, 2013 |
Est. completion date | May 6, 2019 |
Verified date | April 2020 |
Source | University Hospital of Ferrara |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background: A few randomized clinical trials and meta-analysis provide evidence for enhanced
recovery programs (ERPs) in colorectal surgery. Most of the evidence, however, relies on
non-randomized controlled studies that have control groups being either historical or
operated on at different facilities. The aim of this study was to compare a prospective
series of patients undergoing elective colorectal surgery according to ERPs, with a coeval
retrospective series of patients undergoing elective colorectal surgery in a different ward
at the same hospital.
The primary outcome was hospital length of stay, which was used as a proxy of functional
recovery. Secondary outcomes included: postoperative complications, readmission rate,
mortality, and adherence to the protocol.
Materials and Methods: A prospective series of consecutive patients (N = 100) undergoing
elective colorectal resection completing a standardized ERP in 2013-2015 (ERP Group) will be
compared to patients (N = 100) operated at the same institution in the same period with a
traditional perioperative care protocol (Non-ERP group). Despite different surgeons and ward
nurses, the two groups shared the same anaesthesiologists and were located in separate wards.
The exclusion criteria were: >80 years old, ASA score of IV, a stage IV TNM, and diagnosis of
inflammatory bowel disease.
Status | Completed |
Enrollment | 200 |
Est. completion date | May 6, 2019 |
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 |
---|---|
University Hospital of Ferrara |
Aarts MA, Rotstein OD, Pearsall EA, Victor JC, Okrainec A, McKenzie M, McCluskey SA, Conn LG, McLeod RS; iERAS group. Postoperative ERAS Interventions Have the Greatest Impact on Optimal Recovery: Experience With Implementation of ERAS Across Multiple Hospitals. Ann Surg. 2018 Jun;267(6):992-997. doi: 10.1097/SLA.0000000000002632. — View Citation
Depalma N, Cassini D, Grieco M, Barbieri V, Altamura A, Manoochehri F, Viola M, Baldazzi G. Feasibility of a tailored ERAS programme in octogenarian patients undergoing minimally invasive surgery for colorectal cancer. Aging Clin Exp Res. 2020 Feb;32(2):265-273. doi: 10.1007/s40520-019-01195-6. Epub 2019 Apr 13. — View Citation
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. — View Citation
Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg. 2002 Jun;183(6):630-41. Review. — View Citation
Lee TG, Kang SB, Kim DW, Hong S, Heo SC, Park KJ. Comparison of early mobilization and diet rehabilitation program with conventional care after laparoscopic colon surgery: a prospective randomized controlled trial. Dis Colon Rectum. 2011 Jan;54(1):21-8. doi: 10.1007/DCR.0b013e3181fcdb3e. — 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
Pedziwiatr M, Kisialeuski M, Wierdak M, Stanek M, Natkaniec M, Matlok M, Major P, Malczak P, Budzynski A. Early implementation of Enhanced Recovery After Surgery (ERAS®) protocol - Compliance improves outcomes: A prospective cohort study. Int J Surg. 2015 Sep;21:75-81. doi: 10.1016/j.ijsu.2015.06.087. Epub 2015 Jul 29. — View Citation
Portinari M, Ascanelli S, Targa S, Dos Santos Valgode EM, Bonvento B, Vagnoni E, Camerani S, Verri M, Volta CA, Feo CV. Impact of a colorectal enhanced recovery program implementation on clinical outcomes and institutional costs: A prospective cohort stud — View Citation
Serclová Z, Dytrych P, Marvan J, Nová K, Hankeová Z, Ryska O, Slégrová Z, Buresová L, Trávníková L, Antos F. Fast-track in open intestinal surgery: prospective randomized study (Clinical Trials Gov Identifier no. NCT00123456). Clin Nutr. 2009 Dec;28(6):618-24. doi: 10.1016/j.clnu.2009.05.009. Epub 2009 Jun 17. — View Citation
Wang Q, Suo J, Jiang J, Wang C, Zhao YQ, Cao X. Effectiveness of fast-track rehabilitation vs conventional care in laparoscopic colorectal resection for elderly patients: a randomized trial. Colorectal Dis. 2012 Aug;14(8):1009-13. doi: 10.1111/j.1463-1318.2011.02855.x. — View Citation
Wilmore DW, Kehlet H. Management of patients in fast track surgery. BMJ. 2001 Feb 24;322(7284):473-6. Review. — View Citation
Zaouter C, Kaneva P, Carli F. Less urinary tract infection by earlier removal of bladder catheter in surgical patients receiving thoracic epidural analgesia. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):542-8. — View Citation
Zhao JH, Sun JX, Gao P, Chen XW, Song YX, Huang XZ, Xu HM, Wang ZN. Fast-track surgery versus traditional perioperative care in laparoscopic colorectal cancer surgery: a meta-analysis. BMC Cancer. 2014 Aug 23;14:607. doi: 10.1186/1471-2407-14-607. — View Citation
* Note: There are 13 references in all — Click here to view all references
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 | Adherence to the ERP protocol | The ERP protocol includes 21 items; the adherence to the items will be evaluated for each patient in the postoperative period. Then, the adherence rate will be calculated. | Within 10 days from date of surgical operation |
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