Esophagectomy Enhanced Recovery After Surgery Protocol

NCT04750096 | Unknown

• 1 other identifier: ERASE 001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the important advances in anaesthesia and the implementation of perioperative care, pulmonary complications in esophagectomy reach figures of between 20 and 35%, and these complications are also closely associated with the mortality rate. Factors that have been associated with the development of respiratory failure in the literature include among others the presence of previous respiratory pathology, history of smoking, malnutrition and rescue surgery. With the aim of improving morbimortality in patients undergoing esophagectomy, a multidisciplinary protocol based on the best scientific evidence at the present time has been implemented, with actions covering both the preoperative and postoperative areas. Based on this point, a prospective study has been designed that allows us to compare the incidence of respiratory failure before and after the implementation of the protocol.

Conditions

Esophagectomy

Keywords

Esophagectomy; enhanced recovery after surgery; acute lung injury

Outcome Measures

Primary Outcomes (1)

• Post-operative respiratory failure

  Post-operative respiratory failure in esophagectomy after introduction of Enhanced Recovery After Surgery protocol

  1 month

Secondary Outcomes (4)

• Other morbidity

  1 month

• Stay at ICU

  1 month

• Main predisposing factors

  1 month

• Respiratory failure as a prognostic factor

  1 month

Study Arms (1)

Esophagectomy post enhanced recovery after surgery

Patients undergoing esophagectomy due to oesophageal cancer under Enhanced Recovery After Surgery protocol.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing esophagectomy due to oesophageal cancer.

You may qualify if:

• Patients undergone esophagectomy due to neoplastic causes
• Ages between 18 and 90
• Programmed surgery

You may not qualify if:

• Caustic esophagitis
• Esophagectomy for stomach cancer
• Congenital oesophageal malformations
• Respiratory failure at the time of surgery
• Re-interventions of esophagectomy
• Unexpected intraoperative surgical problems

Sponsors & Collaborators

• Raquel Ferrandis Comes: lead

Study Sites (1)

La Fe University and Polytechnic Hospital

Valencia, 46026, Spain

RECRUITING

Related Publications (18)

• Low DE, Kuppusamy MK, Alderson D, Cecconello I, Chang AC, Darling G, Davies A, D'Journo XB, Gisbertz SS, Griffin SM, Hardwick R, Hoelscher A, Hofstetter W, Jobe B, Kitagawa Y, Law S, Mariette C, Maynard N, Morse CR, Nafteux P, Pera M, Pramesh CS, Puig S, Reynolds JV, Schroeder W, Smithers M, Wijnhoven BPL. Benchmarking Complications Associated with Esophagectomy. Ann Surg. 2019 Feb;269(2):291-298. doi: 10.1097/SLA.0000000000002611.

  PMID: 29206677 BACKGROUND

• Takeuchi H, Miyata H, Ozawa S, Udagawa H, Osugi H, Matsubara H, Konno H, Seto Y, Kitagawa Y. Comparison of Short-Term Outcomes Between Open and Minimally Invasive Esophagectomy for Esophageal Cancer Using a Nationwide Database in Japan. Ann Surg Oncol. 2017 Jul;24(7):1821-1827. doi: 10.1245/s10434-017-5808-4. Epub 2017 Feb 21.

  PMID: 28224366 BACKGROUND

• van Adrichem EJ, Meulenbroek RL, Plukker JT, Groen H, van Weert E. Comparison of two preoperative inspiratory muscle training programs to prevent pulmonary complications in patients undergoing esophagectomy: a randomized controlled pilot study. Ann Surg Oncol. 2014 Jul;21(7):2353-60. doi: 10.1245/s10434-014-3612-y. Epub 2014 Mar 7.

  PMID: 24604584 BACKGROUND

• Armestar F, Mesalles E, Font A, Arellano A, Roca J, Klamburg J, Fernandez-Llamazares J. [Serious postoperative complications after esophagectomy for esophageal carcinoma: analysis of risk factors]. Med Intensiva. 2009 Jun-Jul;33(5):224-32. doi: 10.1016/s0210-5691(09)71756-5. Spanish.

  PMID: 19624996 BACKGROUND

• Liu F, Wang W, Wang C, Peng X. Enhanced recovery after surgery (ERAS) programs for esophagectomy protocol for a systematic review and meta-analysis. Medicine (Baltimore). 2018 Feb;97(8):e0016. doi: 10.1097/MD.0000000000010016.

  PMID: 29465538 BACKGROUND

• Findlay JM, Gillies RS, Millo J, Sgromo B, Marshall RE, Maynard ND. Enhanced recovery for esophagectomy: a systematic review and evidence-based guidelines. Ann Surg. 2014 Mar;259(3):413-31. doi: 10.1097/SLA.0000000000000349.

  PMID: 24253135 BACKGROUND

• Lagarde SM, Maris AK, de Castro SM, Busch OR, Obertop H, van Lanschot JJ. Evaluation of O-POSSUM in predicting in-hospital mortality after resection for oesophageal cancer. Br J Surg. 2007 Dec;94(12):1521-6. doi: 10.1002/bjs.5850.

  PMID: 17929231 BACKGROUND

• van der Sluis PC, Schizas D, Liakakos T, van Hillegersberg R. Minimally Invasive Esophagectomy. Dig Surg. 2020;37(2):93-100. doi: 10.1159/000497456. Epub 2019 May 16.

  PMID: 31096214 BACKGROUND

• Lv L, Hu W, Ren Y, Wei X. Minimally invasive esophagectomy versus open esophagectomy for esophageal cancer: a meta-analysis. Onco Targets Ther. 2016 Oct 31;9:6751-6762. doi: 10.2147/OTT.S112105. eCollection 2016.

  PMID: 27826201 BACKGROUND

• Palanivelu C, Prakash A, Senthilkumar R, Senthilnathan P, Parthasarathi R, Rajan PS, Venkatachlam S. Minimally invasive esophagectomy: thoracoscopic mobilization of the esophagus and mediastinal lymphadenectomy in prone position--experience of 130 patients. J Am Coll Surg. 2006 Jul;203(1):7-16. doi: 10.1016/j.jamcollsurg.2006.03.016.

  PMID: 16798482 BACKGROUND

• Kinugasa S, Tachibana M, Yoshimura H, Ueda S, Fujii T, Dhar DK, Nakamoto T, Nagasue N. Postoperative pulmonary complications are associated with worse short- and long-term outcomes after extended esophagectomy. J Surg Oncol. 2004 Nov 1;88(2):71-7. doi: 10.1002/jso.20137.

  PMID: 15499604 BACKGROUND

• Ferguson MK, Celauro AD, Prachand V. Prediction of major pulmonary complications after esophagectomy. Ann Thorac Surg. 2011 May;91(5):1494-1500; discussion 1500-1. doi: 10.1016/j.athoracsur.2010.12.036.

  PMID: 21524462 BACKGROUND

• Kobayashi S, Kanetaka K, Nagata Y, Nakayama M, Matsumoto R, Takatsuki M, Eguchi S. Predictive factors for major postoperative complications related to gastric conduit reconstruction in thoracoscopic esophagectomy for esophageal cancer: a case control study. BMC Surg. 2018 Mar 6;18(1):15. doi: 10.1186/s12893-018-0348-9.

  PMID: 29510754 BACKGROUND

• Biere SS, van Berge Henegouwen MI, Bonavina L, Rosman C, Roig Garcia J, Gisbertz SS, van der Peet DL, Cuesta MA. Predictive factors for post-operative respiratory infections after esophagectomy for esophageal cancer: outcome of randomized trial. J Thorac Dis. 2017 Jul;9(Suppl 8):S861-S867. doi: 10.21037/jtd.2017.06.61.

  PMID: 28815084 BACKGROUND

• Law S, Wong KH, Kwok KF, Chu KM, Wong J. Predictive factors for postoperative pulmonary complications and mortality after esophagectomy for cancer. Ann Surg. 2004 Nov;240(5):791-800. doi: 10.1097/01.sla.0000143123.24556.1c.

  PMID: 15492560 BACKGROUND

• Ferguson MK, Durkin AE. Preoperative prediction of the risk of pulmonary complications after esophagectomy for cancer. J Thorac Cardiovasc Surg. 2002 Apr;123(4):661-9. doi: 10.1067/mtc.2002.120350.

  PMID: 11986593 BACKGROUND

• Choi H, Cho JH, Kim HK, Choi YS, Kim J, Zo JI, Shim YM, Jeon K. Prevalence and clinical course of postoperative acute lung injury after esophagectomy for esophageal cancer. J Thorac Dis. 2019 Jan;11(1):200-205. doi: 10.21037/jtd.2018.12.102.

  PMID: 30863589 BACKGROUND

• Shirinzadeh A, Talebi Y. Pulmonary Complications due to Esophagectomy. J Cardiovasc Thorac Res. 2011;3(3):93-6. doi: 10.5681/jcvtr.2011.020. Epub 2011 Aug 20.

  PMID: 24250962 BACKGROUND

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Silvia Polo, Medical specialist

CONTACT

+34 690 85 39 26; silpomar@mail.ucv.es

Silvia Polo, Medical Specialist

CONTACT

+ 34 690 85 39 26; silpomar@mail.ucv.es

Study Design

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

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 11, 2021
• Study Start: September 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: December 31, 2022
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)