Perioperative CarePOWER3NCT03864861
Postoperative Outcomes Within an Enhanced Recovery After Bariatric Surgery Protocol
An observational study of Perioperative Care and Postoperative Complications, run by Grupo Español de Rehabilitación Multimodal at 53 sites in Spain.
Trial summary
Methods National audit of a 90-day prospective observational cohort in which pre-defined postoperative complications were analyzed at 30 days of follow-up in adult patients undergoing elective bariatric surgery with or without an intensified recovery program (ERAS: Enhanced Recovery after Surgery) with any level of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Care, Postoperative Complications, Bariatric Surgery Candidate
- How many people
- 460 participants
- Where
- 53 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
- Adult, Older adult
Study population: Adult patients (aged ≥18 years) undergoing elective bariatric surgery
Who may be able to join
- All adult patients (aged ≥18 years) undergoing elective bariatric surgery and by any approach (Includes surgery with laparoscopic, assisted laparoscopic approach or open approach) in a participating hospital during the 30-day cohort period with a planned overnight stay.
Who cannot join
- Patients undergoing emergency surgery
- Endoscopic procedures
- Patients under 18 years of age
- Patients with previous bariatric surgery who undergo revision surgery
- Patients who refuse to participate
Trial locations and contacts
53 sites in 1 country.
53 sites in 1 country
Spain53 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 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 General Universitario de Elche
Elche, Alicante
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid
Hospital Universitario Getafe
Getafe, Madrid
Hospital Universitario de Guadalajara
Guadalajara
Hospital Universitario Jerez de La Frontera
Jerez de la Frontera, Cádiz
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria
Hospital Clínico San Carlos
Madrid
Hospital de La Princesa
Madrid
Hospital General Universitario Gregorio Marañón
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Infanta Leonor
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid
Hospital Universitario Virgen del Victoria de Málaga
Málaga, Málaga
Hospital Costa del Sol
Marbella, Málaga
Hospital General Mateu Orfila
Menorca, Menorca
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 Universitario Central de Asturias
Oviedo, Principality of Asturias
Complejo Hospitalario y Universitario de Pontevedra
Pontevedra
Hospital Universitario Quirón Madrid
Pozuelo de Alarcón, Madrid
Hospital Universitario Parc Tauli
Sabadell, Barcelona
Hospital de Sant Joan Despí Moisès Broggi
Sant Joan d'Espi, Barcelona
Hospital Universitario Marqués de Valdecilla
Santander
Hospital Universitario Virgen de Valme
Seville
Hospital Universitario Virgen Macarena
Seville
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 Universitario de Álava
Vitoria-Gasteiz
Hospital Clínico Universitario Lozano Blesa
Zaragoza
Hospital Universitario Miguel Server
Zaragoza
About this study
Official title: Postoperative Outcomes Within an Enhanced Recovery After Bariatric Surgery Protocol POWER3
Methods National audit of a 90-day prospective observational cohort in which pre-defined postoperative complications were analyzed at 30 days of follow-up in adult patients undergoing elective bariatric surgery with or without an intensified recovery program (ERAS: Enhanced Recovery after Surgery) with any level of protocol compliance (0-100%)
Research Places Spanish Hospitals where this surgical intervention is carried out.
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 11%, the sample size calculation yields 460 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 be electively operated on for bariatric surgery regardless of their adherence to an ERAS intensified recovery program and the compliance level of the protocol (from 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 elective bariatric surgery 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 bariatric 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
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 |
|---|---|---|
| Elective Bariatric Surgery | Patients older than 18 undergoing elective bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 European Perioperative Clinical Outcome (EPCO) definitions. Infectious complications, cardiovascular complications and other types of complications. Each complication will be graded as mild, moderate or severe.
Measured: 30 days after surgery
Secondary outcomes (3)
In-hospital all-cause mortality
The percentage of deaths within 30 days of surgery will be reported for each surgical category
Measured: 30 days after surgery
ERAS Compliance
Overall compliance will be calculated as the average of all pre- and intraoperative ERAS adapted elements, as specified in the ERAS society bariatric 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 posted6 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 (1)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
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Español de Rehabilitación Multimodal
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedad Española de Cirugía de la Obesidad, REDGERM
- Responsible party
- Sponsor
- Investigators
- Javier M Ripollés-Melchor, Study chair, Infanta Leonor University Hospital, Madrid, SpainRaquel M Sanchez Santos, Study chair, Complejo Hospitalario Universitario de VigoJosé M Ramírez, Study director, Lozano Blesa University Hospital, Zaragoza, SpainJaime Ruiz Tovar, Study director, Hospital Universitario Rey Juan Carlos Móstoles, SpainCésar Aldecoa, Study director, Hospital Universitario Río Hortega, Valladolid, SpainCarlos Ferrando-Ortolá, Study director, Hospital Clinic of BarcelonaEster Martín García-Almenta, Study director, Hospital Universitario Clínico San Carlos, MadridAne Abad-Motos, Study director, Infanta Leonor University Hospital, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864861
- Sponsor's protocol ID
- REDGERM04
- Acronym
- POWER3
- Status last verified
- Mar 2019
- First submitted
- 4 Mar 2019
- Last updated
- 6 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, Sanchez-Santos R, Abad-Motos A, Gimeno-Moro AM, Diez-Remesal Y, Jove-Albores P, Arago-Chofre P, Ortiz-Sebastian S, Sanchez-Martin R, Ramirez-Rodriguez JM, Trullenque-Juan R, Valenti-Azcarate V, Ramiro-Ruiz A, Correa-Chacon OC, Batalla A, Gimeno-Grauwinkel C, Sanahuja-Blasco JM, Gonzalez-Valverde FM, Galan-Menendez P, Diez-Zapirain MJ, Vilallonga R, Zorrilla-Vaca A, Pascual-Bellosta AM, Martinez-Ubieto J, Carrascosa-Miron T, Ruiz-Escobar A, Martin-Garcia-Almenta E, Suarez-de-la-Rica A, Bausili M, Palacios-Cordoba A, Olvera-Garcia MM, Meza-Vega JA, Sanchez-Pernaute A, Abad-Gurumeta A, Ferrando-Ortola C, Martin-Vaquerizo B, Torres-Alfonso JR, Aguado-Sanchez S, Sanchez-Cabezudo-Noguera F, Garcia-Erce JA, Aldecoa C; POWER 3 Study Investigators Group. Higher Adherence to ERAS Society(R) Recommendations is Associated with Shorter Hospital Stay Without an Increase in Postoperative Complications or Readmissions in Bariatric Surgery: the Association Between Use of Enhanced Recovery After Surgery Protocols and Postoperative Complications after Bariatric Surgery (POWER 3) Multicenter Observational Study. Obes Surg. 2022 Apr;32(4):1289-1299. doi: 10.1007/s11695-022-05949-6. Epub 2022 Feb 10.
PubMed 35143011
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Outcomes Within an Enhanced Recovery After Bariatric Surgery Protocol POWER3
- ClinicalTrials.gov ID
- NCT03864861
- Acronym / sponsor ID
- POWER3 / REDGERM04
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Grupo Español de Rehabilitación MultimodalUniversity, hospital or other
- Collaborators
- Sociedad Española de Cirugía de la Obesidad, REDGERM
- Study start
- 22 Oct 2019 (estimated)
- Primary completion
- 22 Feb 2020 (estimated)
- Study completion
- 22 Mar 2020 (estimated)
- First posted
- 6 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 pre-defined postoperative complications were analyzed at 30 days of follow-up in adult patients undergoing elective bariatric surgery with or without an intensified recovery program (ERAS: Enhanced Recovery after Surgery) with any level of protocol compliance (0-100%)
Research Places Spanish Hospitals where this surgical intervention is carried out.
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 11%, the sample size calculation yields 460 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 be electively operated on for bariatric surgery regardless of their adherence to an ERAS intensified recovery program and the compliance level of the protocol (from 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 elective bariatric surgery 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 bariatric 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 |
|---|---|---|
| Elective Bariatric Surgery | – | –Patients older than 18 undergoing elective bariatric surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients (aged ≥18 years) undergoing elective bariatric surgery
Key inclusion criteria (1 listed)
- All adult patients (aged ≥18 years) undergoing elective bariatric surgery and by any approach (Includes surgery with laparoscopic, assisted laparoscopic approach or open approach) in a participating hospital during the 30-day cohort period with a planned overnight stay.
Key exclusion criteria (5 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
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 European Perioperative Clinical Outcome (EPCO) definitions. Infectious complications, cardiovascular complications and other types of complications. Each complication will be graded as mild, moderate or severe.
3 secondary outcomes
In-hospital all-cause mortality
Time frame: 30 days after surgery
ERAS Compliance
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 6 Mar 2019.
- Derived from this study: PubMed 35143011Ripolles-Melchor J, Sanchez-Santos R, Abad-Motos A, Gimeno-Moro AM, Diez-Remesal Y, Jove-Albores P, Arago-Chofre P, Ortiz-Sebastian S, Sanchez-Martin R, Ramirez-Rodriguez JM, Trullenque-Juan R, Valenti-Azcarate V, Ramiro-Ruiz A, Correa-Chacon OC, Batalla A, Gimeno-Grauwinkel C, Sanahuja-Blasco JM, Gonzalez-Valverde FM, Galan-Menendez P, Diez-Zapirain MJ, Vilallonga R, Zorrilla-Vaca A, Pascual-Bellosta AM, Martinez-Ubieto J, Carrascosa-Miron T, Ruiz-Escobar A, Martin-Garcia-Almenta E, Suarez-de-la-Rica A, Bausili M, Palacios-Cordoba A, Olvera-Garcia MM, Meza-Vega JA, Sanchez-Pernaute A, Abad-Gurumeta A, Ferrando-Ortola C, Martin-Vaquerizo B, Torres-Alfonso JR, Aguado-Sanchez S, Sanchez-Cabezudo-Noguera F, Garcia-Erce JA, Aldecoa C; POWER 3 Study Investigators Group. Higher Adherence to ERAS Society(R) Recommendations is Associated with Shorter Hospital Stay Without an Increase in Postoperative Complications or Readmissions in Bariatric Surgery: the Association Between Use of Enhanced Recovery After Surgery Protocols and Postoperative Complications after Bariatric Surgery (POWER 3) Multicenter Observational Study. Obes Surg. 2022 Apr;32(4):1289-1299. doi: 10.1007/s11695-022-05949-6. Epub 2022 Feb 10.
- 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 M Ripollés-Melchor study chair
Infanta Leonor University Hospital, Madrid, Spain
Raquel M Sanchez Santos study chair
Complejo Hospitalario Universitario de Vigo
José M Ramírez study director
Lozano Blesa University Hospital, Zaragoza, Spain
53 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 53 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 5 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 6 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 53 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 M Ripollés-Melchor (34639776364, jramirez@unizar.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predefined mild-moderate-severe postoperative complications (time frame: 30 days after surgery). 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 NCT03864861, 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 6 Mar 2019.