Clinical trial · Observational
Enhanced Recovery Program in Laparoscopic Colorectal Surgery: an Observational Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Surgery | — | UNRESOLVED | — |
| Recovery of Function | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enhanced Recovery Program (ERP) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- ERP group
- description
- A prospective series of consecutive patients undergoing elective colorectal surgery completing a standardized Enhanced Recovery Program (ERP) protocol at the S. Anna University Hospital in Ferrara (Italy) in 2013-2015
- interventionNames
- Other: Enhanced Recovery Program (ERP)
- label
- Non-ERP group
- description
- A retrospective series of consecutive patients operated at the same hospital (S. Anna University Hospital in Ferrara), in the same period of time (2013-2015), but with a traditional perioperative care protocol.
Primary outcomes (1)
- measure
- Postoperative Hospital Length Of Stay (LOS)
- timeFrame
- Within 10 days from date of surgical operation
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (13)
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- BACKGROUNDLjungqvist 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
- BACKGROUNDWang 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. PMID 21985126
- BACKGROUNDLee 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. PMID 21160309
- BACKGROUNDSerclova Z, Dytrych P, Marvan J, Nova K, Hankeova Z, Ryska O, Slegrova Z, Buresova L, Travnikova 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. PMID 19535182
- BACKGROUNDZhao 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. PMID 25148902
- BACKGROUNDPedziwiatr 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(R)) 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.