Postopoperarive Outcomes After Colorectal Surgery in Europe (euroPOWER)

NCT ID: NCT03814681

Last Updated: 2019-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 8000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-15
• Study Completion Date: 2020-01-15

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

Conditions

Perioperative Care; Colorectal Surgery; Postoperative Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Colorectal Surgery

elective Colorectal Surgery

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GRACE Group

OTHER

Sponsor Role: collaborator

REDGERM

UNKNOWN

Sponsor Role: collaborator

Grupo Español de Rehabilitación Multimodal

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Javier Ripollés-Melchor, MD

Role: STUDY_CHAIR

Infanta Leonor University Hospital, Madrid, Spain

Rupert Pearse, Prof

Role: STUDY_CHAIR

Queen Mary University London, London, UK

José M Ramírez Rodríguez, Prof

Role: STUDY_CHAIR

Lozano Blesa University Hospital, Zaragoza, Spain

Samir Jaber, Prof

Role: STUDY_CHAIR

Hospitalier Universitaire de Montpellier, France

Karim Slim, Prof

Role: STUDY_CHAIR

Président de GRACE

César Aldecoa, Prof

Role: STUDY_CHAIR

Río Hortega University Hospital, Valladolid, Spain

Nader Francis, Prof

Role: STUDY_CHAIR

Yeovil District Hospital NHS Foundation Trust

Ane Abad-Motos, MD

Role: STUDY_CHAIR

Infanta Leonor University Hospital, Madrid, Spain

Locations

Hospital Universitario Infanta Leonor

Madrid, , Spain

Countries

Spain

Central Contacts

Javier Ripollés-Melchor, MD

Role: CONTACT

ripo542@gmail.com

649337762

Javi Ripollés-Melchor

Role: CONTACT

ripo542@gmail.com

649337762

References

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.

Reference Type: BACKGROUND

PMID: 15781793 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23052794 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25058504 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EuroPOWER

Identifier Type: -

Identifier Source: org_study_id