MedTrace Logo

Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol

NCT03012802 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2050

Last updated 2019-01-23

No results posted yet for this study

Summary

Short title POWER Audit

Methods 60 days national (Spain) audit of postoperative complications following elective gastrointestinal surgery within an enhanced recovery after surgery (ERAS) protocol.

Research sites Hospitals undertaking elective lower gastrointestinal surgery. Objective To provide detailed data describing post-operative complications and associated mortality; and length of stay.

To provide detailed data describing adherence to ERAS protocol and its association to morbidity.

Number of patients Not specified. All eligible patients undergoing surgery during the study month. Inclusion Criteria All adult patients (aged ≥18 years) undergoing lower gastrointestinal elective surgery within an ERAS protocol during the 60 day study period.

Statistical analysis 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.

Proposed Start Date A 60 day period between 2017

Proposed End Date

Data collection will end by September 2017

Study Duration Six months

Conditions

  • Perioperative Care
  • Postoperative Complications
  • Colorectal Surgery
  • Critical Pathways

Interventions

PROCEDURE

Colorectal Surgery

Postoperative Audit

Sponsors & Collaborators

  • Grupo Español de Rehabilitación Multimodal

    lead OTHER

Principal Investigators

  • Javier Ripollés Melchor, MD · Grupo Español de Rehabilitación Multimodal

  • José María Calvo Vecino, Prof · Grupo Español de Rehabilitación Multimodal

  • Alfredo Abad-Gurumeta, PhD · Grupo Español de Rehabilitación Multimodal

  • José Manuel Ramírez, Prof · Grupo Español de Rehabilitación Multimodal

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-15
Primary Completion
2018-02-25
Completion
2018-03-25

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03012802 on ClinicalTrials.gov