Adenocarcinoma of StomachPOWER 4 + 3NCT06790238
POWER AUDIT, Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol After Gastric Surgery (POWER 4 + 3)
An observational study of Adenocarcinoma of Stomach and Critical Pathways, run by Grupo Español de Rehabilitación Multimodal at 22 sites in Spain.
Trial summary
The main objective of this study is to analyze the impact on three years survival of an enhanced recovery program (PRI) after radical surgert for adenocarcinoma gastric cancer. As secondaries objectives, we propose to analyze comparing survival distributions between patient groups (ERAS/no ERAS) and the relationship… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of Stomach, Critical Pathways, Enhanced Recovery After Surgery (ERAS) Protocol
- What is being tested?
- gastric surgery and ERAS protocol
- How many people
- 350 participants
- Where
- 22 sitesSpain
- Study dates
- 1 Sep 2024to 15 Jan 2025
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All adult patients (aged ≥18 years) undergoing gastric elective surgery within an ERAS protocol (including patients with 0 compliance) in a participating hospital
Who may be able to join
- All patients over 18 years of age who underwent elective gastric cancer surgery in POWER4
Who cannot join
- Non oncological surgery, refusal of the centers to participate.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Spain22 sites
Hospital Universitario Mancha Centro
Alcázar de San Juan
Hospital Universitario Cruces
Barakaldo
Hospital Clínic de Barcelona
Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Universitario de Basurto
Bilbao
Hospital General Universitario de Ciudad Real
Ciudad Real
Hospital Universitario de Fuenlabrada
Fuenlabrada
Hospital Universitario de Guadalajara
Guadalajara
Hospital Comarcal de Inca
Inca
Hospital Universitario Lucus Augusti Lugo
Lugo
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario de Móstoles
Madrid
Hospital Universitario Infanta Leonor
Madrid
Hospital de Mérida
Mérida
Complexo Hospitalario Universitario de Ourense
Ourense
Hospital Universitario Central de Asturias
Oviedo
Complejo Asistencial universitario de Salamanca
Salamanca
Hospital Sant Joan Despi Moises Broggi
Sant Joan Despí
HU Marqués de Valdecilla
Santander
Hospital Universitario Virgen Macarena
Seville
Hospital Nº Sº Virgen del Prado
Talavera de la Reina
Hospital Universitario Araba
Vitoria-Gasteiz (Álava)
About this study
Official title: POWER AUDIT, Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol After Gastric Surgery
The main objective of this study is to analyze the impact on three years survival of an enhanced recovery program (PRI) after radical surgert for adenocarcinoma gastric cancer. As secondaries objectives, we propose to analyze comparing survival distributions between patient groups (ERAS/no ERAS) and the relationship between the ERAS program and early incorporation into oncology therapies (RIOT).
It is proposed to review the medical records of oncology patients included in POWER 4 (as already foreseen in that study), with the aim of performing a 3-year follow-up.
To create comparable treatment and control groups, the Propensity Index method will be used. To study each variable, multivariate regression will be used. Kaplan-Meier will be used for survival and the log-rank test for comparisons. Significance will be considered if p <0.05 (two tails).
Read the detailed description
Study Data three-year data will be collected from all eligible patients who have undergone elective colorectal surgery within the POWER4 protocol.
Only routine clinical data will be included and, when not available, the field will be left blank, e.g., patients lost to follow-up. Regional groups may supplement their basic data set with a very limited number of additional variables.
Data collection The data will be collected from CRFs collected in POWER4. The list of pseudo-anomized patients delivered at the time will be provided with the new variables to be completed by the centers.
Variables Overall mortality: The number and percentage of deaths occurred since the intervention until the end of the follow-up period.
Overall survival: patients alive from surgery to the last control. Disease-free survival: number of patients alive and without cancer recurrence from the intervention period until the end of follow-up.
Disease recurrence: detected by CT or FCC, from the day of the intervention until the end of the follow-up.
Date until start of adjuvant treatment: date between date of discharge and start of adjuvant treatment
Satistica analyse All regional and institutional level data will be anonymised prior to publication.
Continuous variables will be described as mean and standard deviation, if normally distributed, or median and inter-quartile range, if not normally distributed.
Comparisons of continuous variables will be performed using one-way ANOVA or Mann-Whitney test as appropriate.
Categorical variables will be described as proportions and will be compared using chi-square or Fisher's exact test.
Single-level and hierarchical multi-level logistic regression models will be constructed to identify factors independently associated with these outcomes and to adjust for differences in confounding factors.
Factors will be entered into the models based on their univariate relation to outcome (p<0.05), biological plausibility and low rate of missing data. A stepwise approach will be used to enter new terms.
Results of logistic regression will be reported as adjusted odds ratios (OR) with 95% confidence intervals. The models will be assessed through the use of sensitivity analyses to explore possible interacting factors and examine any effect on the results. A single final analysis is planned at the end of the study.
Survival analyzes will be performed using the Kaplan-Meier method for survival comparisons the log-rank test will be used. The effects will be considered significant if p <0.05.
Monitoring and audit The data collection documents will be audited to ensure that study activities are carried out in accordance with the protocol, good clinical practice and applicable regulatory requirements. In the participating hospitals, local study documents can be selected for local auditing. The quality of the data will be audited.
Limitations of the study Those of a prospective non-randomized study. Difficulty in recruiting patients for potential structural or multidisciplinary team problems. Inappropriate number of patients due loss of follow-up.
- Conditions
- Adenocarcinoma of Stomach, Critical Pathways, Enhanced Recovery After Surgery (ERAS) Protocol, Retrospective Studies, Chemotherapy, Adjuvant, Gastric Cancer
- Being tested
- gastric surgery and ERAS protocol
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric surgery and ERAS protocolOther
Patients under gastric surgery in an ERAS protocol
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Patients alive from surgery to the last control
Measured: 3 years
Disease-free surviva
Number of patients alive and without cancer recurrence from the intervention period until the end of follow-up
Measured: 3 years
Time to disease recurrence
Detected from the day of the intervention until the end of follow-up
Measured: 3 years
Time to return to intended oncologic treatment (RIOT)
Date between discharged and adjuvant treatment
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Sep 2024
- Primary completion15 Jan 2025
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adenocarcinoma of StomachStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Grupo Español de Rehabilitación Multimodal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790238
- Sponsor's protocol ID
- POWER 4 + 3
- Acronym
- POWER 4 + 3
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ripolles-Melchor J, Abad-Motos A, Leon-Bretscher A, Espinosa AV, Amoza-Pais S, Herrero-Bogajo ML, Abad-Gurumeta A, de-la-Plaza-Llamas R, Galan-Menendez P, Zorrilla-Vaca A, Gonzalez-Lopez R, Navarro-Perez R, Jimenez-Vinas C, Parreno-Manchado FC, Ruiz Escobar A, Concepcion-Martin V, Paseiro-Crespo G, Acosta-Merida MA, Puech-de-Oriol M, Mayo-Ossorio MA, Garcia-Nebreda M, Chaveli-Diaz C, Fernandez-Valdes-Bango P, Torres-Alfonso JR, Barragan-Serrano C, Aldecoa C; POWER4 Investigators Group. Disease-free survival after gastrectomy is not influenced by ERAS adherence. Anaesth Crit Care Pain Med. 2026 Apr;45(2):101661. doi: 10.1016/j.accpm.2025.101661. Epub 2025 Oct 30.
PubMed 41175931
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POWER AUDIT, Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol After Gastric Surgery
- ClinicalTrials.gov ID
- NCT06790238
- Acronym / sponsor ID
- POWER 4 + 3 / POWER 4 + 3
- Conditions
- Adenocarcinoma of Stomach, Critical Pathways, Enhanced Recovery After Surgery (ERAS) Protocol, Retrospective Studies, Chemotherapy, Adjuvant, Gastric Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Grupo Español de Rehabilitación MultimodalUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 24 Jan 2025 (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.
The main objective of this study is to analyze the impact on three years survival of an enhanced recovery program (PRI) after radical surgert for adenocarcinoma gastric cancer. As secondaries objectives, we propose to analyze comparing survival distributions between patient groups (ERAS/no ERAS) and the relationship between the ERAS program and early incorporation into oncology therapies (RIOT).
It is proposed to review the medical records of oncology patients included in POWER 4 (as already foreseen in that study), with the aim of performing a 3-year follow-up.
To create comparable treatment and control groups, the Propensity Index method will be used. To study each variable, multivariate regression will be used. Kaplan-Meier will be used for survival and the log-rank test for comparisons. Significance will be considered if p <0.05 (two tails).
Detailed description
Study Data three-year data will be collected from all eligible patients who have undergone elective colorectal surgery within the POWER4 protocol.
Only routine clinical data will be included and, when not available, the field will be left blank, e.g., patients lost to follow-up. Regional groups may supplement their basic data set with a very limited number of additional variables.
Data collection The data will be collected from CRFs collected in POWER4. The list of pseudo-anomized patients delivered at the time will be provided with the new variables to be completed by the centers.
Variables Overall mortality: The number and percentage of deaths occurred since the intervention until the end of the follow-up period.
Overall survival: patients alive from surgery to the last control. Disease-free survival: number of patients alive and without cancer recurrence from the intervention period until the end of follow-up.
Disease recurrence: detected by CT or FCC, from the day of the intervention until the end of the follow-up.
Date until start of adjuvant treatment: date between date of discharge and start of adjuvant treatment
Satistica analyse All regional and institutional level data will be anonymised prior to publication.
Continuous variables will be described as mean and standard deviation, if normally distributed, or median and inter-quartile range, if not normally distributed.
Comparisons of continuous variables will be performed using one-way ANOVA or Mann-Whitney test as appropriate.
Categorical variables will be described as proportions and will be compared using chi-square or Fisher's exact test.
Single-level and hierarchical multi-level logistic regression models will be constructed to identify factors independently associated with these outcomes and to adjust for differences in confounding factors.
Factors will be entered into the models based on their univariate relation to outcome (p<0.05), biological plausibility and low rate of missing data. A stepwise approach will be used to enter new terms.
Results of logistic regression will be reported as adjusted odds ratios (OR) with 95% confidence intervals. The models will be assessed through the use of sensitivity analyses to explore possible interacting factors and examine any effect on the results. A single final analysis is planned at the end of the study.
Survival analyzes will be performed using the Kaplan-Meier method for survival comparisons the log-rank test will be used. The effects will be considered significant if p <0.05.
Monitoring and audit The data collection documents will be audited to ensure that study activities are carried out in accordance with the protocol, good clinical practice and applicable regulatory requirements. In the participating hospitals, local study documents can be selected for local auditing. The quality of the data will be audited.
Limitations of the study Those of a prospective non-randomized study. Difficulty in recruiting patients for potential structural or multidisciplinary team problems. Inappropriate number of patients due loss of follow-up.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients (aged ≥18 years) undergoing gastric elective surgery within an ERAS protocol (including patients with 0 compliance) in a participating hospital
Key inclusion criteria (1 listed)
- All patients over 18 years of age who underwent elective gastric cancer surgery in POWER4
Key exclusion criteria (1 listed)
- Non oncological surgery, refusal of the centers to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gastric surgery and ERAS protocolPatients under gastric surgery in an ERAS protocol | Other | – |
Primary outcome
Overall Survival
Time frame: 3 years
Patients alive from surgery to the last control
Disease-free surviva
Time frame: 3 years
Number of patients alive and without cancer recurrence from the intervention period until the end of follow-up
Time to disease recurrence
Time frame: 3 years
Detected from the day of the intervention until the end of follow-up
Time to return to intended oncologic treatment (RIOT)
Time frame: 3 years
Date between discharged and adjuvant treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Derived from this study: PubMed 41175931Ripolles-Melchor J, Abad-Motos A, Leon-Bretscher A, Espinosa AV, Amoza-Pais S, Herrero-Bogajo ML, Abad-Gurumeta A, de-la-Plaza-Llamas R, Galan-Menendez P, Zorrilla-Vaca A, Gonzalez-Lopez R, Navarro-Perez R, Jimenez-Vinas C, Parreno-Manchado FC, Ruiz Escobar A, Concepcion-Martin V, Paseiro-Crespo G, Acosta-Merida MA, Puech-de-Oriol M, Mayo-Ossorio MA, Garcia-Nebreda M, Chaveli-Diaz C, Fernandez-Valdes-Bango P, Torres-Alfonso JR, Barragan-Serrano C, Aldecoa C; POWER4 Investigators Group. Disease-free survival after gastrectomy is not influenced by ERAS adherence. Anaesth Crit Care Pain Med. 2026 Apr;45(2):101661. doi: 10.1016/j.accpm.2025.101661. Epub 2025 Oct 30.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenocarcinoma of Stomach and Critical Pathways, run by Grupo Español de Rehabilitación Multimodal at 22 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 1 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: under way, not looking for participants, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 3 years). The study lists 4 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 NCT06790238, which also lists 1 linked publication.
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 24 Jan 2025.