Loading search results

Brief 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 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.

Outcome Measures

Primary Outcomes (1)

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.
30 days after surgery

Secondary Outcomes (3)

In-hospital all-cause mortality
30 days after surgery
ERAS Compliance
30 days after surgery
Duration of hospital stay
30 days after surgery

Eligibility Criteria

Age18 Years+

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Adult patients (aged ≥18 years) undergoing elective bariatric surgery

You may qualify if:

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.

You may not qualify if:

Study Sites (53)

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

Related Publications (1)

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.

PMID: 35143011DERIVED

Study Officials

Javier M Ripollés-Melchor

Infanta Leonor University Hospital, Madrid, Spain

STUDY CHAIR

Raquel M Sanchez Santos

Complejo Hospitalario Universitario de Vigo

STUDY CHAIR

José M Ramírez

Lozano Blesa University Hospital, Zaragoza, Spain

STUDY DIRECTOR

Jaime Ruiz Tovar

Hospital Universitario Rey Juan Carlos Móstoles, Spain

STUDY DIRECTOR

Postoperative Outcomes Within an Enhanced Recovery After Bariatric Surgery Protocol

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Elective Bariatric Surgery

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (53)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Source record

Locations

Postoperative Outcomes Within an Enhanced Recovery After Bariatric Surgery Protocol

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Elective Bariatric Surgery

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (53)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Source record

Locations