Postopoperarive Outcomes After Colorectal Surgery in Europe (euroPOWER)

NCT03814681 | Unknown DMC

• 1 other identifier: EuroPOWER
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 1

Brief Summary

Methods 30 days European Multicentre observational cohort study of postoperative complications following elective colorectal surgery within any compliance of an ERAS protocol (including patients with 0 compliance) in a participating hospital during the 30-day cohort period with a planned overnight stay. Research sites Hospitals across Europe with an elective colorrectal surgical service Objective To provide detailed data describing post-operative complications and associated mortality To provide detailed data describing adherence to ERAS protocol and its association to morbidity and length of stay. To provide detailed information on the influence of the volume of patients undergoing surgery on each center and postoperative complications censured at 30 days after surgery. Inclusion criteria All adult patients (aged ≥18 years) undergoing elective colorectal surgery during the 30-day study period. Statistical analysis Number of patients: All eligible patients undergoing elective colorectal surgery during the study month in European participating hospitals. Univariate analysis will be used to test factors (patient, surgical, and ERAS related) associated with surgical complications, length of stay (LOS) and in-hospital death. Single and multi-level logistic regression models will be constructed to identify factors independently associated with these outcomes and to adjust for differences in confounding factors. A stepwise approach will be used to enter new terms. A single final analysis is planned at the end of the study. Summary statistics with post hoc Bonferroni corrections will be used to assess possible dose- response dependence in percentage of patients with postoperative complications and LOS.

Conditions

Perioperative Care; Colorectal Surgery; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Predefined mild-moderate-severe postoperative complications

  Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine were published by the EPCO definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome mesures. infectious complications, cardiovascular complications and other types of complications. Each complication will be graded as mild, moderate or severe.

  30 days after surgery

Secondary Outcomes (3)

• In-hospital all-cause mortality

  30 days after surgery

• Compliance with ERAS items

  30 days after surgery

• Duration of hospital stay

  30 days after surgery

Interventions

Colorectal Surgery OTHER

elective Colorectal Surgery

Eligibility Criteria

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

Study Population

adult patients (aged ≥18 years) undergoing primary elective colorectal surgery

You may qualify if:

• All adult patients (aged ≥18 years) undergoing primary elective colorectal surgery and by any approach (Includes surgery with laparoscopic, assisted laparoscopic approach or open approach) in a participating hospital during the 30-day cohort period with a planned overnight stay.

You may not qualify if:

• Patients submitted for emergency surgery
• Patients with complex cancer who required resection of organs other than bowel. (i.e. kidney, gastric resection, ovarian)• Patients treated with endoscopic techniques using the hybrid TaTME technique (Transanal Total Mesorectal Excision)
• Bowel transit reconstruction surgery
• Patients who refuse to participate

Sponsors & Collaborators

• Grupo Español de Rehabilitación Multimodal: lead
• GRACE Group: collaborator
• REDGERM: collaborator

Study Sites (1)

Hospital Universitario Infanta Leonor

Madrid, Spain

Location

Related Publications (3)

• Alves A, Panis Y, Mathieu P, Mantion G, Kwiatkowski F, Slim K; Association Francaise de Chirurgie. Postoperative mortality and morbidity in French patients undergoing colorectal surgery: results of a prospective multicenter study. Arch Surg. 2005 Mar;140(3):278-83, discussion 284. doi: 10.1001/archsurg.140.3.278.

  PMID: 15781793 BACKGROUND

• Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. No abstract available.

  PMID: 23052794 BACKGROUND

• Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.

  PMID: 25058504 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Javier Ripollés-Melchor, MD

  Infanta Leonor University Hospital, Madrid, Spain

  STUDY CHAIR

• Rupert Pearse, Prof

  Queen Mary University London, London, UK

  STUDY CHAIR

• José M Ramírez Rodríguez, Prof

  Lozano Blesa University Hospital, Zaragoza, Spain

  STUDY CHAIR

• Samir Jaber, Prof

  Hospitalier Universitaire de Montpellier, France

  STUDY CHAIR

• Karim Slim, Prof

  Président de GRACE

  STUDY CHAIR

• César Aldecoa, Prof

  Río Hortega University Hospital, Valladolid, Spain

  STUDY CHAIR

• Nader Francis, Prof

  Yeovil District Hospital NHS Foundation Trust

  STUDY CHAIR

• Ane Abad-Motos, MD

  Infanta Leonor University Hospital, Madrid, Spain

  STUDY CHAIR

Central Study Contacts

Javier Ripollés-Melchor, MD

CONTACT

649337762; ripo542@gmail.com

Javi Ripollés-Melchor

CONTACT

649337762; ripo542@gmail.com

Study Design

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

Study Record Dates

• First Submitted: January 20, 2019
• First Posted: January 24, 2019
• Study Start: September 15, 2019
• Primary Completion: December 15, 2019
• Study Completion: January 15, 2020
• Last Updated: January 25, 2019

Record last verified: 2019-01

Locations

ES (1)