Postopoperarive Outcomes After Colorectal Surgery in Europe (euroPOWER) (EuroPOWER)

• ClinicalTrials.gov Identifier: NCT03814681
• Recruitment Status: Unknown
• First Posted: January 24, 2019
• Last Update Posted: January 25, 2019
• Sponsor: Grupo Español de Rehabilitación Multimodal
• Collaborators: GRACE Group; REDGERM
• Information provided by (Responsible Party): Grupo Español de Rehabilitación Multimodal

Tracking Information

• First Submitted Date: January 20, 2019
• First Posted Date: January 24, 2019
• Last Update Posted Date: January 25, 2019
• Estimated Study Start Date: September 15, 2019
• Estimated Primary Completion Date: December 15, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 23, 2019)

Predefined mild-moderate-severe postoperative complications [ Time Frame: 30 days after surgery ]

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: January 23, 2019)

• In-hospital all-cause mortality [ Time Frame: 30 days after surgery ]
  The number and percentage of deaths within 30 days of surgery will be reported for each surgical category
• Compliance with ERAS items [ Time Frame: 30 days after surgery ]
  Overall compliance will be calculated as the average of all pre- and intraoperative ERAS adapted elements, as specified in the ERAS society colon and rectal guidelines ERAS patients' guideline compliance will be categorised into quartiles
• Duration of hospital stay [ Time Frame: 30 days after surgery ]
  The median hospital length of stay (LOS) following the start of surgery, overall, by survival status and by complication status will be reported. Post-operative LOS is the duration in days from the date of the end of surgery to the date of discharge from hospital.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Postopoperarive Outcomes After Colorectal Surgery in Europe (euroPOWER)
• Official Title: Postoperative Outcomes Within/Without an Enhanced Recovery After Surgery Protocol in Colorectal Surgery Across Europe

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.

Detailed Description

The results of this study will allow to identify, on the one hand, the type of patients presenting postoperative complications and, on the other hand, to identify those items of the ERAS protocols that are independently associated with a reduction in postoperative complications and hospital stay, which will allow to focus the perioperative efforts in those items that actually improve the postoperative outcomes.

• Aim 1 will establish the number of patients developing predefined postoperative complications within 30 days of surgery in adult patients undergoing elective colorectal surgery with any compliance of an ERAS protocol (including patients with 0 compliance). This will allow us to determine the actual impact of these protocols.
• Aim 2 will allow us to know the type of predefined complication presented by the patients included in the ERAS protocols and in patients undergoing colorectal surgery; This will allow, on the one hand, to have a starting point for future clinical trials, and, on the other hand, to focus efforts to avoid these complications.
• Aim 3 will allow us to identify those perioperative items of ERAS protocols that are actually associated with a decrease in postoperative complications.

The proposed study will establish a real view of the number of patients presenting postoperative complications that will overcome the limitations of available retrospective studies and provide greater insight into the items of the protocols that are associated with decreased complications; on the other hand, our hypothesis is that the number of patients who develop predefined postoperative complications within 30 days of surgery decreases as there is greater compliance with the predefined ERAS protocol items

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: adult patients (aged ≥18 years) undergoing primary elective colorectal surgery

Condition

• Perioperative Care
• Colorectal Surgery
• Postoperative Complications

Intervention

Other: Colorectal Surgery

elective Colorectal Surgery

• Study Groups/Cohorts: Not Provided

Publications *

• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 23, 2019): 8000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 15, 2020
• Estimated Primary Completion Date: December 15, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT03814681
• Other Study ID Numbers: EuroPOWER
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Grupo Español de Rehabilitación Multimodal
• Original Responsible Party: Same as current
• Current Study Sponsor: Grupo Español de Rehabilitación Multimodal
• Original Study Sponsor: Same as current

Collaborators

• GRACE Group
• REDGERM

Investigators

• Study Chair: 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

• PRS Account: Grupo Español de Rehabilitación Multimodal
• Verification Date: January 2019