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Postopoperarive Outcomes After Colorectal Surgery in Europe (euroPOWER)

Postoperative Outcomes Within/Without an Enhanced Recovery After Surgery Protocol in Colorectal Surgery Across Europe

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03814681
Acronym
EuroPOWER
Enrollment
8000
Registered
2019-01-24
Start date
2019-09-15
Completion date
2020-01-15
Last updated
2019-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Surgery, Perioperative Care, Postoperative Complications

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

Interventions

OTHERColorectal Surgery

elective Colorectal Surgery

Sponsors

GRACE Group
CollaboratorOTHER
REDGERM
CollaboratorUNKNOWN
Grupo Español de Rehabilitación Multimodal
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Predefined mild-moderate-severe postoperative complications30 days after surgeryStandards 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.

Secondary

MeasureTime frameDescription
In-hospital all-cause mortality30 days after surgeryThe number and percentage of deaths within 30 days of surgery will be reported for each surgical category
Compliance with ERAS items30 days after surgeryOverall 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 stay30 days after surgeryThe 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.

Countries

Spain

Contacts

Primary ContactJavier Ripollés-Melchor, MD
ripo542@gmail.com649337762
Backup ContactJavi Ripollés-Melchor
ripo542@gmail.com649337762

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026