Enhanced Recovery Program in Laparoscopic Colorectal Surgery: an Observational Controlled Trial

NCT04378465 | Completed

• 1 other identifier: 52-2011
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Colorectal Surgery; Recovery of Function

Keywords

Laparoscopy; Enhanced Recovery After Surgery; Colorectal Neoplasms

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 (4)

• 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

• Adherence to the ERP protocol

  Within 10 days from date of surgical operation

Study Arms (2)

ERP group

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

Other: Enhanced Recovery Program (ERP)

Non-ERP group

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.

Interventions

Enhanced Recovery Program (ERP) OTHER

An evidence-based perioperative care approach, involving a multidisciplinary team work including surgeons, anaesthesiologists, dieticians, and nurses, which aim to reduce the surgical stress and metabolic responses as well as organ dysfunction, thus leading to a faster recovery after surgery

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 vs Non-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

Related Publications (13)

• Wilmore DW, Kehlet H. Management of patients in fast track surgery. BMJ. 2001 Feb 24;322(7284):473-6. doi: 10.1136/bmj.322.7284.473. No abstract available.

  PMID: 11222424 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 BACKGROUND

• 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.

  PMID: 21985126 BACKGROUND

• 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.

  PMID: 21160309 BACKGROUND

• Serclova 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 BACKGROUND

• 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.

  PMID: 25148902 BACKGROUND

• 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(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.

  PMID: 26231994 BACKGROUND

• 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.

  PMID: 30982218 BACKGROUND

• 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.

  PMID: 29303803 BACKGROUND

• Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg. 2002 Jun;183(6):630-41. doi: 10.1016/s0002-9610(02)00866-8.

  PMID: 12095591 BACKGROUND

• 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. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• 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. doi: 10.1097/aap.0b013e3181ae9fac.

  PMID: 19916208 BACKGROUND

• 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 study with retrospective control. Int J Surg. 2018 May;53:206-213. doi: 10.1016/j.ijsu.2018.03.005. Epub 2018 Mar 13.

  PMID: 29548700 RESULT

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 Officials

• Carlo V Feo, MD

  University Hospital of Ferrara, Italy

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 7, 2020
• Study Start: January 11, 2013
• Primary Completion: December 18, 2015
• Study Completion: May 6, 2019
• Last Updated: May 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share