ERAS Program in Thoracic Surgery Analyzed the Effects on the Rates of Complications, Readmission and Length of Stay

NCT04579601 | Completed DMC

• 1 other identifier: EO071-18_FJD
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer is the leading cause of cancer death worldwide, representing 20,55% and 14% of cancer deaths in Spain and the United States, respectively. Currently, pulmonary resection is the treatment of choice for lung cancer. However, this surgery is associated with significant complications in almost 50% of the cases, possibly delaying patient recovery and consequently increasing hospitalisation costs. Professor Henrik Kehlet described ERAS programs at the end of the last century. His ideas were that the application of specific measures based on scientific evidence during the perioperative period of the patient could decrease the stress produced by surgical aggression. Thus, in recent years, ERAS programs have proven effective in reducing surgical complications, length of stay and hospital costs. Over the last years, specific ERAS surgical approaches have been described for thoracic surgery. Nevertheless, there is still a lack of evidence to support ERAS programs for pulmonary resection surgery, particularly in terms of clinical results combined with minimally invasive procedures. Our study aims to analyze the effects of the implementation of an ERAS program in patients undergoing pulmonary resection in a tertiary university hospital on the rates of complications and readmission and the length of stay.

Conditions

Thoracic Surgery

Keywords

Fast-track rehabilitation; ERAS; VATS

Outcome Measures

Primary Outcomes (1)

• Rate of Surgical complication

  We defined air leakage, bleeding, infection, and reintervention as surgical complications.

  30 days

Secondary Outcomes (1)

• Rate of Non surgical complication

  30 days

Other Outcomes (2)

• ERAS Adherence

  30 days

• Mortality

  30 days

Study Arms (2)

ERAS group

We recruited 50 patients throughout 2018 and 2019, patients undergoing thoracic surgery within an ERAS program

Procedure: ERAS program

Standard group

A group of 50 patients selected randomly prior the implementation of the ERAS program, in 2016.

Interventions

ERAS program PROCEDURE

We designed our centre's ERAS program through different measures during the preoperative, intraoperative and postoperative period. This program incluided received comprehensive multidisciplinary information, daily goals and expected discharge date, explained the expansión exercises, the video-assisted thoracoscopic surgery (VATS) under general anaesthesia combined with regional techniques, leaving only one chest tube at the end of the surgery, maintain normothermia, extubation after the end of the surgery, and early removal of the urinary catheter. From the time of extubation, the patients began oral tolerance and respiratory physiotherapy exercises. Also, the patients were allowed to walk around early.

ERAS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

After informed consent, we included patients consecutively since the implementation, except those who refused the inclusion in the study or were under 18 years old. We also asked for informed consent from the patients who were part of the retrospective cohort

You may qualify if:

• All the patients undergoing of a thoracic surgery during the recruitmet period with
• \>18 years
• always after informed consent.

You may not qualify if:

• PAtients without consent
• \<18 years

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead

Study Sites (1)

Fundación Jiménez Díaz University Hospital

Madrid, 28040, Spain

Location

Related Publications (5)

• Das-Neves-Pereira JC, Bagan P, Coimbra-Israel AP, Grimaillof-Junior A, Cesar-Lopez G, Milanez-de-Campos JR, Riquet M, Biscegli-Jatene F. Fast-track rehabilitation for lung cancer lobectomy: a five-year experience. Eur J Cardiothorac Surg. 2009 Aug;36(2):383-91; discussion 391-2. doi: 10.1016/j.ejcts.2009.02.020. Epub 2009 Mar 26.

  PMID: 19324571 BACKGROUND

• ERAS Compliance Group. The Impact of Enhanced Recovery Protocol Compliance on Elective Colorectal Cancer Resection: Results From an International Registry. Ann Surg. 2015 Jun;261(6):1153-9. doi: 10.1097/SLA.0000000000001029.

  PMID: 25671587 BACKGROUND

• Muehling BM, Halter GL, Schelzig H, Meierhenrich R, Steffen P, Sunder-Plassmann L, Orend KH. Reduction of postoperative pulmonary complications after lung surgery using a fast track clinical pathway. Eur J Cardiothorac Surg. 2008 Jul;34(1):174-80. doi: 10.1016/j.ejcts.2008.04.009. Epub 2008 May 19.

  PMID: 18490173 BACKGROUND

• Ripolles-Melchor J, Ramirez-Rodriguez JM, Casans-Frances R, Aldecoa C, Abad-Motos A, Logrono-Egea M, Garcia-Erce JA, Camps-Cervantes A, Ferrando-Ortola C, Suarez de la Rica A, Cuellar-Martinez A, Marmana-Mezquita S, Abad-Gurumeta A, Calvo-Vecino JM; POWER Study Investigators Group for the Spanish Perioperative Audit and Research Network (REDGERM). Association Between Use of Enhanced Recovery After Surgery Protocol and Postoperative Complications in Colorectal Surgery: The Postoperative Outcomes Within Enhanced Recovery After Surgery Protocol (POWER) Study. JAMA Surg. 2019 Aug 1;154(8):725-736. doi: 10.1001/jamasurg.2019.0995.

  PMID: 31066889 BACKGROUND

• Falcoz PE, Puyraveau M, Thomas PA, Decaluwe H, Hurtgen M, Petersen RH, Hansen H, Brunelli A; ESTS Database Committee and ESTS Minimally Invasive Interest Group. Video-assisted thoracoscopic surgery versus open lobectomy for primary non-small-cell lung cancer: a propensity-matched analysis of outcome from the European Society of Thoracic Surgeon database. Eur J Cardiothorac Surg. 2016 Feb;49(2):602-9. doi: 10.1093/ejcts/ezv154. Epub 2015 Apr 26.

  PMID: 25913824 RESULT

Study Officials

• Soledad Bellas

  Institut Fundación Jiménez Díaz

  PRINCIPAL INVESTIGATOR

• Luis E Muñoz

  Instituto Fundación Jiménez Díaz

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: October 8, 2020
• Study Start: January 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: December 31, 2019
• Last Updated: October 28, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: starting 6 months after publication
• Access Criteria: Upon request the database will be shared, if it were to be included in another study, they would have to include us as collaborators of the same

Locations

ES (1)