Postoperative Outcomes Within an Enhanced Recovery After Bariatric Surgery Protocol

• Conditions: Perioperative Care; Bariatric Surgery Candidate; Postoperative Complications

• Registration Number: NCT03864861
• Lead Sponsor: Grupo Español de Rehabilitación Multimodal

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.

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 Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-03-05
• Last Update Submitted: 2019-03-05
• Study First Posted: 2019-03-06
• Last Update Posted: 2019-03-06
• Study Start: 2019-10-22
• Primary Completion: 2020-02-22
• Study Completion: 2020-03-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 460

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predefined mild-moderate-severe postoperative complications	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.

Secondary Outcome Measures

Name	Time	Method
In-hospital all-cause mortality	30 days after surgery	The percentage of deaths within 30 days of surgery will be reported for each surgical category
ERAS Compliance	30 days after surgery	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
Duration of hospital stay	30 days after surgery	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.

Trial Locations

Locations (53)

Hospital Universitario de Cruces; 🇪🇸 Baracaldo, Bizkaia, Spain

Hospital General Universitario de Castellón; 🇪🇸 Castellon de la Plana, Castellón, Spain

Hospital Universitario de Vic; 🇪🇸 Vic, Barcelona, Spain

Hospital de Sant Joan Despí Moisès Broggi; 🇪🇸 Sant Joan d'Espi, Barcelona, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

Hospital de Mérida; 🇪🇸 Mérida, Badajoz, Spain

Hospital Costa del Sol; 🇪🇸 Marbella, Málaga, Spain

Hospital Universitario Puerta del Mar; 🇪🇸 Cadiz, Cádiz, Spain

Hospital Virgen de los Lirios de Alcoy; 🇪🇸 Alcoy, Alicante, Spain

Hospital General Universitario de Elche; 🇪🇸 Elche, Alicante, Spain

Hospital Universitario Jerez de La Frontera; 🇪🇸 Jerez de La Frontera, Cádiz, Spain

Hospital Universitario Getafe; 🇪🇸 Getafe, Madrid, Spain

Hospital Universitario Puerta de Hierro; 🇪🇸 Majadahonda, Madrid, Spain

Hospital Rey Juan Carlos; 🇪🇸 Mostoles, Madrid, Spain

Hospital Universitario Virgen del Victoria de Málaga; 🇪🇸 Malaga, Málaga, Spain

Hospital Clínic Universitat de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitario de Burgos; 🇪🇸 Burgos, Spain

Hospital Universitario Vall d´Hebrón; 🇪🇸 Barcelona, Spain

Hospital General Universitario de Ciudad Real; 🇪🇸 Ciudad Real, Spain

Hospital Universitario de Guadalajara; 🇪🇸 Guadalajara, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital de La Princesa; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen de Valme; 🇪🇸 Sevilla, Spain

Hospital Universitario Infanta Leonor; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital General Mateu Orfila; 🇪🇸 Menorca, Spain

Hospital General Universitario José María Morales Messeguer; 🇪🇸 Murcia, Spain

Hospital Universitario La Fe; 🇪🇸 Valencia, Spain

Complejo Hospitalario y Universitario de Pontevedra; 🇪🇸 Pontevedra, Spain

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Spain

Complejo Hospitalario de Toledo; 🇪🇸 Toledo, Spain

Hospital Universitario Príncipe de Asturias; 🇪🇸 Alcalá de Henares, Madrid, Spain

Hospital Universitario Fundación Alcorcón; 🇪🇸 Alcorcón, Madrid, Spain

Complejo Hospitalario Universitario de A Coruña; 🇪🇸 A Coruna, Coruña, Spain

Hospital Universitario de Fuenlabrada; 🇪🇸 Fuenlabrada, Madrid, Spain

Hospital Universitario de Móstoles; 🇪🇸 Mostoles, Madrid, Spain

Hospital Universitario Quirón Madrid; 🇪🇸 Pozuelo de Alarcon, Madrid, Spain

Hospital Universitario de Torrejón; 🇪🇸 Torrejon de Ardoz, Madrid, Spain

Hospital Universitario Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitario Insular de Gran Canaria; 🇪🇸 Las Palmas de Gran Canaria, Spain

Hospital Universitario de Gran Canaria Doctor Negrín; 🇪🇸 Las Palmas, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario Marqués de Valdecilla; 🇪🇸 Santander, Spain

Hospital Clínico de Valladolid; 🇪🇸 Valladolid, Spain

Hospital General Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Universitario Río Hortega; 🇪🇸 Valladolid, Spain

Hospital Universitario de Álava; 🇪🇸 Vitoria, Spain

Hospital Clínico Universitario Lozano Blesa; 🇪🇸 Zaragoza, Spain

Hospital Universitario Miguel Server; 🇪🇸 Zaragoza, Spain

Hospital Universitario Parc Tauli; 🇪🇸 Sabadell, Barcelona, Spain