Postoperative Outcomes Within an Enhanced Recovery After Bariatric Surgery Protocol

Postoperative Complications Clinical Trial

— POWER3  

Official title:

Postoperative Outcomes Within an Enhanced Recovery After Bariatric Surgery Protocol POWER3

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03864861
• Other study ID #: REDGERM04
• Status: Not yet recruiting
• Start date: October 22, 2019
• Est. completion date: March 22, 2020

Study information

• Verified date: March 2019
• Source: Grupo Español de Rehabilitación Multimodal
• Contact: Javier M Ripollés-Melchor
• Phone: 34639776364
• Email: jramirez[@]unizar.es
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 460
• Est. completion date: March 22, 2020
• Est. primary completion date: February 22, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Perioperative Care
• Postoperative Complications

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario de A Coruña	A Coruna	Coruña
Spain	Hospital Universitario Príncipe de Asturias	Alcalá de Henares	Madrid
Spain	Hospital Universitario Fundación Alcorcón	Alcorcón	Madrid
Spain	Hospital Virgen de los Lirios de Alcoy	Alcoy	Alicante
Spain	Hospital Universitario de Cruces	Baracaldo	Bizkaia
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 Universitario Puerta del Mar	Cadiz	Cádiz
Spain	Hospital General Universitario de Castellón	Castellon de la Plana	Castellón
Spain	Hospital General Universitario de Ciudad Real	Ciudad Real
Spain	Hospital General Universitario de Elche	Elche	Alicante
Spain	Hospital Universitario de Fuenlabrada	Fuenlabrada	Madrid
Spain	Hospital Universitario Getafe	Getafe	Madrid
Spain	Hospital Universitario de Guadalajara	Guadalajara
Spain	Hospital Universitario Jerez de La Frontera	Jerez de La Frontera	Cádiz
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 Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Universitario Virgen del Victoria de Málaga	Malaga	Málaga
Spain	Hospital Costa del Sol	Marbella	Málaga
Spain	Hospital General Mateu Orfila	Menorca
Spain	Hospital de Mérida	Mérida	Badajoz
Spain	Hospital Rey Juan Carlos	Mostoles	Madrid
Spain	Hospital Universitario de Móstoles	Mostoles	Madrid
Spain	Hospital General Universitario José María Morales Messeguer	Murcia
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Complejo Hospitalario y Universitario de Pontevedra	Pontevedra
Spain	Hospital Universitario Quirón Madrid	Pozuelo de Alarcon	Madrid
Spain	Hospital Universitario Parc Tauli	Sabadell	Barcelona
Spain	Hospital de Sant Joan Despí Moisès Broggi	Sant Joan d'Espi	Barcelona
Spain	Hospital Universitario Marqués de Valdecilla	Santander
Spain	Hospital Universitario Virgen de Valme	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Complejo Hospitalario de Toledo	Toledo
Spain	Hospital Universitario de Torrejón	Torrejon de Ardoz	Madrid
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 Vic	Vic	Barcelona
Spain	Hospital Universitario de Álava	Vitoria
Spain	Hospital Clínico Universitario Lozano Blesa	Zaragoza
Spain	Hospital Universitario Miguel Server	Zaragoza

Sponsors (3)

Lead Sponsor	Collaborator
Grupo Español de Rehabilitación Multimodal	REDGERM, Sociedad Española de Cirugía de la Obesidad

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	In-hospital all-cause mortality	The percentage of deaths within 30 days of surgery will be reported for each surgical category	30 days after surgery
Secondary	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	30 days after surgery
Secondary	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.	30 days after surgery