NCT03012802

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,050

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

80 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

September 15, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2018

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

5 months

First QC Date

January 4, 2017

Last Update Submit

January 20, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • The incidence of 60-day predefined (according EPCO guidelines) postoperative complications following elective lower gastrointestinal surgery within any compliance of an ERAS protocol.

    To confirm the incidence of 30-day in-hospital complications following elective in-patient surgery.

    30 days

Secondary Outcomes (1)

  • 30-day in-hospital mortality associated with these complications

    30 days

Other Outcomes (1)

  • Relationship between ERAS adherence and post- operative complications

    30 days

Interventions

Postoperative Audit

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Patients undergoing emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (80)

Hospital Virgen de los Lirios de Alcoy

Alcoy, Alicante, Spain

Location

Hospital General Universitario de Elche

Elche, Alicante, Spain

Location

Hospital Don Benito-Villanueva de la Serena

Don Benito-Villanueva de La Serena, Badajoz, Spain

Location

Hospital de Mérida

Mérida, Badajoz, Spain

Location

Hospital de Igualada

Igualada, Barcelona, Spain

Location

Hospital Universitario Parc Tauli

Sabadell, Barcelona, Spain

Location

Hospital de Sant Joan Despí Moisès Broggi

Sant Joan d'Espi, Barcelona, Spain

Location

Fundación Hospital del Espíritu Santo

Santa Coloma de Gramanet, Barcelona, Spain

Location

Hospital Mútua Terrassa

Terrassa, Barcelona, Spain

Location

Hospital Universitario de Vic

Vic, Barcelona, Spain

Location

OSI Alto Deba

Arrasate / Mondragón, Bilbao, Spain

Location

Hospital Universitario de Cruces

Barakaldo, Bizkaia, Spain

Location

Hospital Comarcal de Laredo

Laredo, Cantabria, Spain

Location

Hospital de Sierrallana

Torrelavega, Cantabria, Spain

Location

Hospital General Universitario de Castellón

Castellon, Castellón, Spain

Location

Hospital Comarcal de Vinaroz

Vinaròs, Castellón, Spain

Location

Complejo Hospitalario Universitario de A Coruña

A Coruña, Coruña, Spain

Location

Hospital Virgen del Puerto

Plasencia, Cáceres, Spain

Location

Hospital Universitario Puerta del Mar

Cadiz, Cádiz, Spain

Location

Hospital Universitario Jerez de La Frontera

Jerez de la Frontera, Cádiz, Spain

Location

Hospital San Pedro

Logroño, La Rioja, Spain

Location

Complejo Asistencial Universitario de León

León, León, Spain

Location

Hospital Universitario Príncipe de Asturias

Alcalá de Henares, Madrid, Spain

Location

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain

Location

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, Spain

Location

Hospital Universitario Getafe

Getafe, Madrid, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Location

Hospital Rey Juan Carlos

Móstoles, Madrid, Spain

Location

Hospital Universitario de Móstoles

Móstoles, Madrid, Spain

Location

Hospital Universitario Quirón Madrid

Pozuelo de Alarcón, Madrid, Spain

Location

Hospital Universitario de Torrejón

Torrejón de Ardoz, Madrid, Spain

Location

Hospital Comarcal de Inca

Inca, Mallorca, Spain

Location

Hospital de Manacor

Manacor, Mallorca, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, Mallorca, Spain

Location

Hospital General Mateu Orfila

Menorca, Menorca, Spain

Location

Hospital Rafael Méndez

Lorca, Murcia, Spain

Location

Hospital Costa del Sol

Marbella, Málaga, Spain

Location

Hospital Universitario Virgen del Victoria de Málaga

Málaga, Málaga, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Navarre, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Location

Hospital General de La Palma

Santa Cruz de Tenerife, Tenerife, Spain

Location

Hospital Nuestra Señora del Prado

Talavera de la Reina, Toledo, Spain

Location

Hospital de Manises

Manises, Valencia, Spain

Location

Hospital General Universitario de Alicante

Alicante, Spain

Location

Hospital 2 de Mayo

Barcelona, Spain

Location

Hospital Clínic Universitat de Barcelona

Barcelona, Spain

Location

Hospital Universitario Sant Pau

Barcelona, Spain

Location

Hospital Universitario Vall d´Hebrón

Barcelona, Spain

Location

Hospital Universitario de Burgos

Burgos, Spain

Location

Hospital General Universitario de Ciudad Real

Ciudad Real, Spain

Location

Hospital Universitario de Guadalajara

Guadalajara, Spain

Location

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas, Spain

Location

Hospital Universitario Insular de Gran Canaria

Las Palmas de Gran Canaria, Spain

Location

Hospital Universitario Arnau de Vilanova

Lleida, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital de La Princesa

Madrid, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Hospital General Universitario José María Morales Messeguer

Murcia, Spain

Location

Hospital Reina Sofía

Murcia, Spain

Location

Complejo Hospitalario y Universitario de Pontevedra

Pontevedra, Spain

Location

Complejo Hospitalario de Salamanca

Salamanca, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Location

Complejo Asistencial de Segovia

Segovia, Spain

Location

Hospital Universitario Virgen de Valme

Seville, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Spain

Location

Complejo Hospitalario de Toledo

Toledo, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, Spain

Location

Hospital General Universitario de Valencia

Valencia, Spain

Location

Hospital Universitario La Fe

Valencia, Spain

Location

Hospital Clínico de Valladolid

Valladolid, Spain

Location

Hospital Universitario Río Hortega

Valladolid, Spain

Location

Hospital Universitario de Álava

Vitoria-Gasteiz, Spain

Location

Complejo Asistencial de Zamora

Zamora, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain

Location

Hospital Royo Vilanova

Zaragoza, Spain

Location

Hospital Universitario Miguel Server

Zaragoza, Spain

Location

Related Publications (1)

  • Suarez-de-la-Rica A, Ripolles-Melchor J, Abad-Motos A, Aldecoa C, Ferrando C, Abad-Gurumeta A, Diaz-Almiron M, Casans-Frances R, Logrono-Egea M, Garcia-Erce JA, Ramirez Rodriguez JM, Cuellar-Martinez A, Marmana-Mezquita S, Maseda E; POWER Study Investigators Group for the Spanish Perioperative Audit and Research Network (RedGERM-SPARN). Association of perioperative fluid balance and acute kidney injury in patients undergoing elective colorectal surgery: A pre-planned secondary analysis of a multicentre prospective observational study. Eur J Anaesthesiol. 2026 Jan 8. doi: 10.1097/EJA.0000000000002339. Online ahead of print.

Related Links

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Javier Ripollés Melchor, MD

    Grupo Español de Rehabilitación Multimodal

    STUDY CHAIR
  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 4, 2017

First Posted

January 6, 2017

Study Start

September 15, 2017

Primary Completion

February 25, 2018

Study Completion

March 25, 2018

Last Updated

January 23, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

Data will be available under request

Available IPD Datasets

Study Protocol Access
Statistical Analysis Plan Access
Clinical Study Report Access

Locations