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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03814681
Recruitment Status : Unknown
Verified January 2019 by Grupo Español de Rehabilitación Multimodal.
Recruitment status was:  Not yet recruiting
First Posted : January 24, 2019
Last Update Posted : January 25, 2019
Sponsor:
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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
Responsible Party Grupo Español de Rehabilitación Multimodal
Study Sponsor Grupo Español de Rehabilitación Multimodal
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