Postoperative Outcomes Within an Enhanced Recovery After Bariatric Surgery Protocol

NCT03864861 | Unknown

• 1 other identifier: REDGERM04
• Study Type: observational
• Target: 460
• Locations: 1 country
• Sites: 53

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.

Conditions

Perioperative Care; Postoperative Complications; Bariatric Surgery Candidate

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

Study Arms (1)

Elective Bariatric Surgery

Patients older than 18 undergoing elective bariatric surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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:

• 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

Sponsors & Collaborators

• Grupo Español de Rehabilitación Multimodal: lead
• Sociedad Española de Cirugía de la Obesidad: collaborator
• REDGERM: collaborator

Study Sites (53)

Hospital Virgen de los Lirios de Alcoy

Alcoy, Alicante, Spain

Location

Hospital General Universitario de Elche

Elche, Alicante, Spain

Location

Hospital de Mérida

Mérida, Badajoz, Spain

Location

Hospital Universitario Parc Tauli

Sabadell, Barcelona, Spain

Location

Hospital de Sant Joan Despí Moisès Broggi

Sant Joan d'Espi, Barcelona, Spain

Location

Hospital Universitario de Vic

Vic, Barcelona, Spain

Location

Hospital Universitario de Cruces

Barakaldo, Bizkaia, Spain

Location

Hospital General Universitario de Castellón

Castellon, Castellón, Spain

Location

Complejo Hospitalario Universitario de A Coruña

A Coruña, Coruña, Spain

Location

Hospital Universitario Puerta del Mar

Cadiz, Cádiz, Spain

Location

Hospital Universitario Jerez de La Frontera

Jerez de la Frontera, Cádiz, Spain

Location

Hospital Universitario Príncipe de Asturias

Alcalá de Henares, Madrid, Spain

Location

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain

Location

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, Spain

Location

Hospital Universitario Getafe

Getafe, Madrid, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Location

Hospital Rey Juan Carlos

Móstoles, Madrid, Spain

Location

Hospital Universitario de Móstoles

Móstoles, Madrid, Spain

Location

Hospital Universitario Quirón Madrid

Pozuelo de Alarcón, Madrid, Spain

Location

Hospital Universitario de Torrejón

Torrejón de Ardoz, Madrid, Spain

Location

Hospital General Mateu Orfila

Menorca, Menorca, Spain

Location

Hospital Costa del Sol

Marbella, Málaga, Spain

Location

Hospital Universitario Virgen del Victoria de Málaga

Málaga, Málaga, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Location

Hospital Clínic Universitat de Barcelona

Barcelona, Spain

Location

Hospital Universitario Sant Pau

Barcelona, Spain

Location

Hospital Universitario Vall d´Hebrón

Barcelona, Spain

Location

Hospital Universitario de Burgos

Burgos, Spain

Location

Hospital General Universitario de Ciudad Real

Ciudad Real, Spain

Location

Hospital Universitario de Guadalajara

Guadalajara, Spain

Location

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas, Spain

Location

Hospital Universitario Insular de Gran Canaria

Las Palmas de Gran Canaria, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital de La Princesa

Madrid, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Hospital General Universitario José María Morales Messeguer

Murcia, Spain

Location

Complejo Hospitalario y Universitario de Pontevedra

Pontevedra, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Location

Hospital Universitario Virgen de Valme

Seville, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Spain

Location

Complejo Hospitalario de Toledo

Toledo, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, Spain

Location

Hospital General Universitario de Valencia

Valencia, Spain

Location

Hospital Universitario La Fe

Valencia, Spain

Location

Hospital Clínico de Valladolid

Valladolid, Spain

Location

Hospital Universitario Río Hortega

Valladolid, Spain

Location

Hospital Universitario de Álava

Vitoria-Gasteiz, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain

Location

Hospital Universitario Miguel Server

Zaragoza, Spain

Location

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: 35143011 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

• César Aldecoa

  Hospital Universitario Río Hortega, Valladolid, Spain

  STUDY DIRECTOR

• Carlos Ferrando-Ortolá

  Hospital Clinic of Barcelona

  STUDY DIRECTOR

• Ester Martín García-Almenta

  Hospital Universitario Clínico San Carlos, Madrid

  STUDY DIRECTOR

• Ane Abad-Motos

  Infanta Leonor University Hospital, Madrid, Spain

  STUDY DIRECTOR

• Alfredo Abad-Gurumeta

  Infanta Leonor University Hospital, Madrid, Spain

  STUDY DIRECTOR

• Alejandro Suárez de la Rica

  Hospital Universitario La Paz

  STUDY DIRECTOR

Central Study Contacts

Javier M Ripollés-Melchor

CONTACT

34639776364; jramirez@unizar.es

Jose M Ramírez

CONTACT

34639776364; jramirez@unizar.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 6, 2019
• Study Start: October 22, 2019
• Primary Completion: February 22, 2020
• Study Completion: March 22, 2020
• Last Updated: March 6, 2019

Record last verified: 2019-03

Locations

ES (53)