Postoperative Outcomes Within an Enhanced Recovery After Bariatric Surgery Protocol
NCT ID: NCT03864861
Last Updated: 2019-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
460 participants
OBSERVATIONAL
2019-10-22
2020-03-22
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Elective Bariatric Surgery
Patients older than 18 undergoing elective bariatric surgery
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Endoscopic procedures
* Patients under 18 years of age
* Patients with previous bariatric surgery who undergo revision surgery
* Patients who refuse to participate
18 Years
ALL
No
Sponsors
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Sociedad Española de Cirugía de la Obesidad
UNKNOWN
REDGERM
UNKNOWN
Grupo Español de Rehabilitación Multimodal
OTHER
Responsible Party
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Principal Investigators
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Javier M Ripollés-Melchor
Role: STUDY_CHAIR
Infanta Leonor University Hospital, Madrid, Spain
Raquel M Sanchez Santos
Role: STUDY_CHAIR
Complejo Hospitalario Universitario de Vigo
José M Ramírez
Role: STUDY_DIRECTOR
Lozano Blesa University Hospital, Zaragoza, Spain
Jaime Ruiz Tovar
Role: STUDY_DIRECTOR
Hospital Universitario Rey Juan Carlos Móstoles, Spain
César Aldecoa
Role: STUDY_DIRECTOR
Hospital Universitario Río Hortega, Valladolid, Spain
Carlos Ferrando-Ortolá
Role: STUDY_DIRECTOR
Hospital Clinic of Barcelona
Ester Martín García-Almenta
Role: STUDY_DIRECTOR
Hospital Universitario Clínico San Carlos, Madrid
Ane Abad-Motos
Role: STUDY_DIRECTOR
Infanta Leonor University Hospital, Madrid, Spain
Alfredo Abad-Gurumeta
Role: STUDY_DIRECTOR
Infanta Leonor University Hospital, Madrid, Spain
Alejandro Suárez de la Rica
Role: STUDY_DIRECTOR
Hospital Universitario La Paz
Locations
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Hospital Virgen de los Lirios de Alcoy
Alcoy, Alicante, Spain
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital de Mérida
Mérida, Badajoz, Spain
Hospital Universitario Parc Tauli
Sabadell, Barcelona, Spain
Hospital de Sant Joan Despí Moisès Broggi
Sant Joan d'Espi, Barcelona, Spain
Hospital Universitario de Vic
Vic, Barcelona, Spain
Hospital Universitario de Cruces
Barakaldo, Bizkaia, Spain
Hospital General Universitario de Castellón
Castellon, Castellón, Spain
Complejo Hospitalario Universitario de A Coruña
A Coruña, Coruña, Spain
Hospital Universitario Puerta del Mar
Cadiz, Cádiz, Spain
Hospital Universitario Jerez de La Frontera
Jerez de la Frontera, Cádiz, Spain
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, Spain
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain
Hospital Universitario Getafe
Getafe, Madrid, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Rey Juan Carlos
Móstoles, Madrid, Spain
Hospital Universitario de Móstoles
Móstoles, Madrid, Spain
Hospital Universitario Quirón Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario de Torrejón
Torrejón de Ardoz, Madrid, Spain
Hospital General Mateu Orfila
Menorca, Menorca, Spain
Hospital Costa del Sol
Marbella, Málaga, Spain
Hospital Universitario Virgen del Victoria de Málaga
Málaga, Málaga, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Clínic Universitat de Barcelona
Barcelona, , Spain
Hospital Universitario Sant Pau
Barcelona, , Spain
Hospital Universitario Vall d´Hebrón
Barcelona, , Spain
Hospital Universitario de Burgos
Burgos, , Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, , Spain
Hospital Universitario de Guadalajara
Guadalajara, , Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas, , Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital de La Princesa
Madrid, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Infanta Leonor
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital General Universitario José María Morales Messeguer
Murcia, , Spain
Complejo Hospitalario y Universitario de Pontevedra
Pontevedra, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Hospital Universitario Virgen de Valme
Seville, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Complejo Hospitalario de Toledo
Toledo, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Hospital Clínico de Valladolid
Valladolid, , Spain
Hospital Universitario Río Hortega
Valladolid, , Spain
Hospital Universitario de Álava
Vitoria-Gasteiz, , Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, , Spain
Hospital Universitario Miguel Server
Zaragoza, , Spain
Countries
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Central Contacts
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References
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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.
Other Identifiers
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REDGERM04
Identifier Type: -
Identifier Source: org_study_id
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