Perioperative CarePOWER4NCT03865810
Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol in Gastric Surgery for Cancer
An observational study of Perioperative Care and Postoperative Complications, run by Grupo Español de Rehabilitación Multimodal at 66 sites in Spain.
Trial summary
Methods National audit of a 90-day prospective observational cohort in which postoperative complications will be analyzed at 30 days of follow-up in adult patients undergoing scheduled surgery for gastric resection for cancer with or without an intensified recovery program (ERAS : Enhanced Recovery after Surgery) with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Care, Postoperative Complications, Gastric Cancer
- How many people
- 861 participants
- Where
- 66 sitesSpain
- Study dates
- 22 Oct 2019to 22 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years of age undergoing gastric resection surgery due to cancer
Who may be able to join
- All patients over 18 years of age undergoing gastric resection surgery due to cancer within or not of an intensified recovery program (ERAS) with any level of compliance with the protocol (from 0-100%).
Who cannot join
- Patients undergoing emergency surgery
- Endoscopic procedures
- Non-oncological gastric surgery
- Patients who refuse to participate
Trial locations and contacts
66 sites in 1 country.
66 sites in 1 country
Spain66 sites
Complejo Hospitalario Universitario de A Coruña
A Coruña, Coruña
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid
Hospital Virgen de los Lirios de Alcoy
Alcoy, Alicante
Hospital General Universitario de Alicante
Alicante
Hospital Universitario de Cruces
Barakaldo, Bizkaia
Hospital Clínic Universitat de Barcelona
Barcelona
Hospital Universitario Sant Pau
Barcelona
Hospital Universitario Vall d´Hebrón
Barcelona
Hospital Universitario de Burgos
Burgos
Hospital Universitario Puerta del Mar
Cadiz, Cádiz
Hospital General Universitario de Castellón
Castellon, Castellón
Hospital General Universitario de Ciudad Real
Ciudad Real
Hospital Don Benito-Villanueva de la Serena
Don Benito-Villanueva de La Serena, Badajoz
Hospital General Universitario de Elche
Elche, Alicante
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid
Hospital Universitario Getafe
Getafe, Madrid
Hospital Universitario de Guadalajara
Guadalajara
Hospital de Igualada
Igualada, Barcelona
Hospital Comarcal de Inca
Inca, Mallorca
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria
Complejo Asistencial Universitario de León
León, León
Hospital Universitario Arnau de Vilanova
Lleida
Hospital Rafael Méndez
Lorca, Murcia
Hospital Clínico San Carlos
Madrid
Hospital de La Princesa
Madrid
Hospital General Universitario Gregorio Marañón
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid
Hospital de Manacor
Manacor, Mallorca
Hospital de Manises
Manises, Valencia
Hospital Costa del Sol
Marbella, Málaga
Hospital de Mérida
Mérida, Badajoz
Hospital Rey Juan Carlos
Móstoles, Madrid
Hospital Universitario de Móstoles
Móstoles, Madrid
Hospital General Universitario José María Morales Messeguer
Murcia
Hospital Reina Sofía
Murcia
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias
Complejo Hospitalario de Navarra
Pamplona, Navarre
Complejo Hospitalario y Universitario de Pontevedra
Pontevedra
Hospital Universitario Quirón Madrid
Pozuelo de Alarcón, Madrid
Hospital Universitario Parc Tauli
Sabadell, Barcelona
Complejo Hospitalario de Salamanca
Salamanca
Hospital de Sant Joan Despí Moisès Broggi
Sant Joan d'Espi, Barcelona
Fundación Hospital del Espíritu Santo
Santa Coloma de Gramanet, Barcelona
Hospital Universitario Marqués de Valdecilla
Santander
Complejo Asistencial de Segovia
Segovia
Hospital Universitario Virgen de Valme
Seville
Hospital Universitario Virgen Macarena
Seville
Hospital Nuestra Señora del Prado
Talavera de la Reina, Toledo
Hospital Mútua Terrassa
Terrassa, Barcelona
Complejo Hospitalario de Toledo
Toledo
Hospital Universitario de Torrejón
Torrejón de Ardoz, Madrid
Hospital Clínico Universitario de Valencia
Valencia
Hospital General Universitario de Valencia
Valencia
Hospital Universitario La Fe
Valencia
Hospital Clínico de Valladolid
Valladolid
Hospital Universitario Río Hortega
Valladolid
Hospital Universitario de Vic
Vic, Barcelona
Hospital Comarcal de Vinaroz
Vinaròs, Castellón
Hospital Universitario de Álava
Vitoria-Gasteiz
Complejo Asistencial de Zamora
Zamora
Hospital Clínico Universitario Lozano Blesa
Zaragoza
About this study
Official title: Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol in Gastric Surgery for Cancer (POWER .4)
Methods National audit of a 90-day prospective observational cohort in which postoperative complications will be analyzed at 30 days of follow-up in adult patients undergoing scheduled surgery for gastric resection for cancer with or without an intensified recovery program (ERAS : Enhanced Recovery after Surgery) with any level of protocol compliance (from 0-100%)
Research Locations Spanish Hospitals at the state level where these surgical interventions are performed on a regular basis.
Read more
Objectives To determine the incidence of postoperative complications per patient and procedure, regardless of the degree of adherence to ERAS protocols and its impact on the hospital stay and postoperative complications including 30-day mortality.
Sample Size For an alpha error of 5% (95% confidence) and an accuracy of 3% and estimating a number of patients with complications of 28%, the sample size calculation yields 861 patients, although the final sample size it may be smaller depending on the proportion of complications detected.
Inclusion criteria Patients older than 18 years who are going to undergo surgery for gastric resection surgery due to cancer regardless of their affiliation to an ERAS intensified recovery program and the compliance level of the protocol (0-100%)
Statistical analysis Continuous variables will be described as mean and standard deviation, if it is a normal distribution, or median and interquartile range, if they are not normally distributed. Comparisons of continuous variables will be performed by one-way ANOVA or the Mann-Whitney test, as appropriate. A univariate analysis will be performed to test the factors associated with postoperative complications, hospital stay and death in the hospital. Univariate analyzes and hierarchical multivariate logistic regression models will be constructed to identify factors associated independently with these results and to adjust for differences in confounding factors. The factors will be introduced in the models based on their relationship with the univariate result (p <0.05), the biological plausibility and the low rate of missing data.
Read the 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 scheduled surgery for gastric resection for cancer 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, the investigator's 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
- Medical subject headings
- Postoperative Complications, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gastric Surgery | Adult patients undergoing elective gastric surgery for cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with predefined mild-moderate-severe postoperative complications
Standards 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.
Measured: 30 days after surgery
Number of patients with predefined mild-moderate-severe postoperative complications (gastric cancer surgery specific)
Each complication will be graded as mild, moderate or severe.
Measured: 30 days after surgery
Secondary outcomes (3)
In-hospital all-cause mortality
The number and percentage of deaths within 30 days of surgery will be reported for each surgical category
Measured: 30 days after surgery
Compliance with ERAS items
Overall 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
Measured: 30 days after surgery
Duration of hospital stay
The 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
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start22 Oct 2019 (estimated)
- Primary completion22 Feb 2020 (estimated)
- Study completion22 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Perioperative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 861 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Español de Rehabilitación Multimodal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier Ripollés-Melchor, Study chair, Infanta Leonor University Hospital, Madrid, SpainMarcos Bruna Esteban, Study chair, Hospital General Universitario de Valencia, SpainJosé M Ramírez Rodríguez, Study chair, Lozano Blesa University Hospital, Zaragoza, SpainCésar Aldecoa, Study chair, Hospital Universitario Río Hortega, Valladolid SpainAne Abad Motos, Study chair, Infanta Leonor University Hospital, Madrid, SpainPeter Vorwald, Study director, Hospital Universitario Fundación Jiménez Díaz. Madrid, SpainGloria Crespo, Study director, Infanta Leonor University Hospital, Madrid, SpainCarlos Ferrando Ortolá, Study director, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865810
- Sponsor's protocol ID
- REDGERM05
- Acronym
- POWER4
- Status last verified
- Mar 2019
- First submitted
- 4 Mar 2019
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ripolles-Melchor J, Abad-Motos A, Bruna-Esteban M, Garcia-Nebreda M, Otero-Martinez I, Abdel-Lah Fernandez O, Tormos-Perez MP, Paseiro-Crespo G, Garcia-Alvarez R, A Mayo-Ossorio M, Zugasti-Echarte O, Nespereira-Garcia P, Gil-Gomez L, Logrono-Ejea M, Risco R, Parreno-Manchado FC, Gil-Trujillo S, Benito C, Jerico C, De-Miguel-Cabrera MI, Ugarte-Sierra B, Barragan-Serrano C, Garcia-Erce JA, Munoz-Hernandez H, Rio-Fernandez SD, Herrero-Bogajo ML, Espinosa-Moreno AM, Concepcion-Martin V, Zorrilla-Vaca A, Vaquero-Perez L, Mojarro I, Llacer-Perez M, Gomez-Viana L, Fernandez-Martin MT, Abad-Gurumeta A, Ferrando-Ortola C, Ramirez-Rodriguez JM, Aldecoa C; POWER Study Investigators Group. Association between use of enhanced recovery after surgery protocols and postoperative complications after gastric surgery for cancer (POWER 4): a nationwide, prospective multicentre study. Cir Esp (Engl Ed). 2023 Oct;101(10):665-677. doi: 10.1016/j.cireng.2023.04.011. Epub 2023 Apr 23.
PubMed 37094777Abad-Motos A, Ripolles-Melchor J, Bruna-Esteban M, Ferrando-Ortola C, Paseiro-Crespo G, Abad-Gurumeta A, Garcia-Erce JA, Jerico C, Ramirez JM, Aldecoa C. Postoperative Outcomes Within an Enhanced Recovery after surgery protocol in gastric surgery for cancer (POWER.4): Study protocol for a prospective, multicentre, observational cohort study. Rev Esp Anestesiol Reanim (Engl Ed). 2020 Mar;67(3):130-138. doi: 10.1016/j.redar.2019.10.004. Epub 2019 Nov 22. English, Spanish.
PubMed 31767197
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol in Gastric Surgery for Cancer (POWER .4)
- ClinicalTrials.gov ID
- NCT03865810
- Acronym / sponsor ID
- POWER4 / REDGERM05
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 861 participants (estimated)
- Lead sponsor
- Grupo Español de Rehabilitación MultimodalUniversity, hospital or other
- Study start
- 22 Oct 2019 (estimated)
- Primary completion
- 22 Feb 2020 (estimated)
- Study completion
- 22 Mar 2020 (estimated)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Methods National audit of a 90-day prospective observational cohort in which postoperative complications will be analyzed at 30 days of follow-up in adult patients undergoing scheduled surgery for gastric resection for cancer with or without an intensified recovery program (ERAS : Enhanced Recovery after Surgery) with any level of protocol compliance (from 0-100%)
Research Locations Spanish Hospitals at the state level where these surgical interventions are performed on a regular basis.
Objectives To determine the incidence of postoperative complications per patient and procedure, regardless of the degree of adherence to ERAS protocols and its impact on the hospital stay and postoperative complications including 30-day mortality.
Sample Size For an alpha error of 5% (95% confidence) and an accuracy of 3% and estimating a number of patients with complications of 28%, the sample size calculation yields 861 patients, although the final sample size it may be smaller depending on the proportion of complications detected.
Inclusion criteria Patients older than 18 years who are going to undergo surgery for gastric resection surgery due to cancer regardless of their affiliation to an ERAS intensified recovery program and the compliance level of the protocol (0-100%)
Statistical analysis Continuous variables will be described as mean and standard deviation, if it is a normal distribution, or median and interquartile range, if they are not normally distributed. Comparisons of continuous variables will be performed by one-way ANOVA or the Mann-Whitney test, as appropriate. A univariate analysis will be performed to test the factors associated with postoperative complications, hospital stay and death in the hospital. Univariate analyzes and hierarchical multivariate logistic regression models will be constructed to identify factors associated independently with these results and to adjust for differences in confounding factors. The factors will be introduced in the models based on their relationship with the univariate result (p <0.05), the biological plausibility and the low rate of missing data.
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 scheduled surgery for gastric resection for cancer 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, the investigator's 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric Surgery | – | –Adult patients undergoing elective gastric surgery for cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age undergoing gastric resection surgery due to cancer
Key inclusion criteria (1 listed)
- All patients over 18 years of age undergoing gastric resection surgery due to cancer within or not of an intensified recovery program (ERAS) with any level of compliance with the protocol (from 0-100%).
Key exclusion criteria (4 listed)
- Patients undergoing emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with predefined mild-moderate-severe postoperative complications
Time frame: 30 days after surgery
Standards 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.
Number of patients with predefined mild-moderate-severe postoperative complications (gastric cancer surgery specific)
Time frame: 30 days after surgery
Each complication will be graded as mild, moderate or severe.
3 secondary outcomes
In-hospital all-cause mortality
Time frame: 30 days after surgery
Compliance with ERAS items
Time frame: 30 days after surgery
Duration of hospital stay
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Derived from this study: PubMed 37094777Ripolles-Melchor J, Abad-Motos A, Bruna-Esteban M, Garcia-Nebreda M, Otero-Martinez I, Abdel-Lah Fernandez O, Tormos-Perez MP, Paseiro-Crespo G, Garcia-Alvarez R, A Mayo-Ossorio M, Zugasti-Echarte O, Nespereira-Garcia P, Gil-Gomez L, Logrono-Ejea M, Risco R, Parreno-Manchado FC, Gil-Trujillo S, Benito C, Jerico C, De-Miguel-Cabrera MI, Ugarte-Sierra B, Barragan-Serrano C, Garcia-Erce JA, Munoz-Hernandez H, Rio-Fernandez SD, Herrero-Bogajo ML, Espinosa-Moreno AM, Concepcion-Martin V, Zorrilla-Vaca A, Vaquero-Perez L, Mojarro I, Llacer-Perez M, Gomez-Viana L, Fernandez-Martin MT, Abad-Gurumeta A, Ferrando-Ortola C, Ramirez-Rodriguez JM, Aldecoa C; POWER Study Investigators Group. Association between use of enhanced recovery after surgery protocols and postoperative complications after gastric surgery for cancer (POWER 4): a nationwide, prospective multicentre study. Cir Esp (Engl Ed). 2023 Oct;101(10):665-677. doi: 10.1016/j.cireng.2023.04.011. Epub 2023 Apr 23.
- Derived from this study: PubMed 31767197Abad-Motos A, Ripolles-Melchor J, Bruna-Esteban M, Ferrando-Ortola C, Paseiro-Crespo G, Abad-Gurumeta A, Garcia-Erce JA, Jerico C, Ramirez JM, Aldecoa C. Postoperative Outcomes Within an Enhanced Recovery after surgery protocol in gastric surgery for cancer (POWER.4): Study protocol for a prospective, multicentre, observational cohort study. Rev Esp Anestesiol Reanim (Engl Ed). 2020 Mar;67(3):130-138. doi: 10.1016/j.redar.2019.10.004. Epub 2019 Nov 22. English, Spanish.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Ripollés-Melchor study chair
Infanta Leonor University Hospital, Madrid, Spain
Marcos Bruna Esteban study chair
Hospital General Universitario de Valencia, Spain
José M Ramírez Rodríguez study chair
Lozano Blesa University Hospital, Zaragoza, Spain
66 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Care and Postoperative Complications, run by Grupo Español de Rehabilitación Multimodal at 66 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javier Ripollés-Mellchor (34 649337762, ripo542@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with predefined mild-moderate-severe postoperative complications (time frame: 30 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03865810, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2019.