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Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol (POWER)

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ClinicalTrials.gov Identifier: NCT03012802
Recruitment Status : Active, not recruiting
First Posted : January 6, 2017
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Javier Ripollés Melchor, Grupo Español de Rehabilitación Multimodal

Brief 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


Condition or disease Intervention/treatment
Perioperative Care Postoperative Complications Colorectal Surgery Critical Pathways Procedure: Colorectal Surgery

  Show Detailed Description

Study Type : Observational [Patient Registry]
Actual Enrollment : 2050 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol in Lower Gastrointestinal Surgery
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : February 25, 2018
Estimated Study Completion Date : February 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery


Intervention Details:
  • Procedure: Colorectal Surgery
    Postoperative Audit


Primary Outcome Measures :
  1. The incidence of 60-day predefined (according EPCO guidelines) postoperative complications following elective lower gastrointestinal surgery within any compliance of an ERAS protocol. [ Time Frame: 30 days ]
    To confirm the incidence of 30-day in-hospital complications following elective in-patient surgery.


Secondary Outcome Measures :
  1. 30-day in-hospital mortality associated with these complications [ Time Frame: 30 days ]

Other Outcome Measures:
  1. Relationship between ERAS adherence and post- operative complications [ Time Frame: 30 days ]
    To confirm the relationship between ERAS items (according ERAS guidelines) and the predefined postoperative complications.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All adult patients (aged ≥18 years) undergoing elective lower gastrointestinal surgery within any compliance of an ERAS protocol (including patients with 0 compliance) in a participating hospital during the 60-day cohort period with a planned overnight stay.
Criteria

Inclusion Criteria:

  • All adult patients (aged ≥18 years) undergoing elective lower gastrointestinal surgery within any compliance of an ERAS protocol (including patients with 0 compliance) in a participating hospital during the 60-day cohort period with a planned overnight stay.

SURGERY SCHEDULED IN THE INCLUSION CRITERIA

  • Right hemicolectomy
  • Resection of transverse colon
  • Left hemicolectomy
  • Sigmoidectomy
  • Low anterior resection of the rectum
  • Abdominoperineal rectal amputation
  • Subtotal colectomy
  • Total colectomy

Exclusion Criteria:

  • Patients undergoing emergency surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03012802


  Show 80 Study Locations
Sponsors and Collaborators
Grupo Español de Rehabilitación Multimodal
Investigators
Study Chair: Javier Ripollés Melchor, MD Grupo Español de Rehabilitación Multimodal
Principal Investigator: José María Calvo Vecino, Prof Grupo Español de Rehabilitación Multimodal
Principal Investigator: Alfredo Abad-Gurumeta, PhD Grupo Español de Rehabilitación Multimodal
Principal Investigator: José Manuel Ramírez, Prof Grupo Español de Rehabilitación Multimodal

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Responsible Party: Javier Ripollés Melchor, Principal Investigator, Grupo Español de Rehabilitación Multimodal
ClinicalTrials.gov Identifier: NCT03012802     History of Changes
Other Study ID Numbers: GERM01
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be available under request

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes