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Postoperative Outcomes Within an Enhanced Recovery After Bariatric Surgery Protocol (POWER3)

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ClinicalTrials.gov Identifier: NCT03864861
Recruitment Status : Not yet recruiting
First Posted : March 6, 2019
Last Update Posted : March 6, 2019
Sponsor:
Collaborators:
Sociedad Española de Cirugía de la Obesidad
REDGERM
Information provided by (Responsible Party):
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.


Condition or disease
Perioperative Care Postoperative Complications Bariatric Surgery Candidate

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


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Study Type : Observational
Estimated Enrollment : 460 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postoperative Outcomes Within an Enhanced Recovery After Bariatric Surgery Protocol POWER3
Estimated Study Start Date : October 22, 2019
Estimated Primary Completion Date : February 22, 2020
Estimated Study Completion Date : March 22, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Elective Bariatric Surgery
Patients older than 18 undergoing elective bariatric surgery



Primary Outcome Measures :
  1. Predefined mild-moderate-severe postoperative complications [ Time Frame: 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 :
  1. In-hospital all-cause mortality [ Time Frame: 30 days after surgery ]
    The percentage of deaths within 30 days of surgery will be reported for each surgical category

  2. ERAS Compliance [ Time Frame: 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

  3. Duration of hospital stay [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult patients (aged ≥18 years) undergoing elective bariatric surgery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864861


Contacts
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Contact: Javier M Ripollés-Melchor 34639776364 jramirez@unizar.es
Contact: Jose M Ramírez 34639776364 jramirez@unizar.es

  Show 53 Study Locations
Sponsors and Collaborators
Grupo Español de Rehabilitación Multimodal
Sociedad Española de Cirugía de la Obesidad
REDGERM
Investigators
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Study Chair: Javier M Ripollés-Melchor Infanta Leonor University Hospital, Madrid, Spain
Study Chair: Raquel M Sanchez Santos Complejo Hospitalario Universitario de Vigo
Study Director: 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

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Responsible Party: Grupo Español de Rehabilitación Multimodal
ClinicalTrials.gov Identifier: NCT03864861     History of Changes
Other Study ID Numbers: REDGERM04
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes