Interdisciplinary Perioperative Care in Minimally-invasive Heart Valve Surgery
NCT ID: NCT04977362
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
201 participants
INTERVENTIONAL
2021-07-01
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ERAS protocol (intervention group)
The innovative care process in the intervention group is characterized by an interdisciplinary approach according to the previously established enhanced recovery after surgery protocol. This process aims at improving the clinical outcome after cardiac surgery, increasing patient satisfaction and quality of life, enabling early professional reentry and participation, and optimizing the cost-effectiveness of service provision. In addition, intersectoral barriers are being broken down in order to establish an interdisciplinary and cross-sectoral overall care process for patients with heart valve surgery as a new form of care in the future.
Enhanced Recovery After Surgery
Enhanced recovery after surgery is a multimodal, transdisciplinary care approach for patients undergoing surgical procedures. It is implemented in various surgical specialties, among others in cardiac surgery. The care approach aims at promotion of recovery of the patients throughout their perioperative process, reduction of complications, and early return to normal activities.
Treatment as usual (control group)
The control group undergoes standard heart valve surgery. In this case, no preoperative interventions take place, the patient is operated on the affected heart valve in a minimally invasive procedure without prehabilitation. After surgery, the patient is transfered to an intensive care unit (not a specialized postanesthesia care unit) depending on the individual condition and then transfered to the general ward. Patients receive medical, nursing, and physiotherapeutic care in accordance with current hospital standards.
Treatment as Usual
treatment as usual according to standard care in heart valve surgery
Interventions
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Enhanced Recovery After Surgery
Enhanced recovery after surgery is a multimodal, transdisciplinary care approach for patients undergoing surgical procedures. It is implemented in various surgical specialties, among others in cardiac surgery. The care approach aims at promotion of recovery of the patients throughout their perioperative process, reduction of complications, and early return to normal activities.
Treatment as Usual
treatment as usual according to standard care in heart valve surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient's ability to understand the nature and extent of the individual's requirements for participation in the new care setting
* Classification of the patient as "FIT" or "Pre-FRAIL" using the LUCAS functional index (frailty index) (Dapp et al. 2012)
Exclusion Criteria
* Urgent or emergency interventions
* Severe chronic obstructive pulmonary disease (GOLD III or IV)
* Dialysis-dependant renal failure
* Advanced liver cirrhosis (Child stages B + C)
* Severe comorbidities or psychosocial reasons that militate against participation or do not allow for written informed consent (e. g., residual neurological impairment after prior stroke, major restrictions of mobility, neuropsychological disorders, depressive disorder, substance-related addictive disorders)
* Lack of a social environment that can provide supportive patient care
* Previous cardiac surgery (i.e., relative contraindication for minimally invasive technique)
18 Years
ALL
No
Sponsors
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BARMER
OTHER
University Hospital Augsburg
OTHER
Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
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Evaldas Girdauskas
Prof. Dr. med.
Principal Investigators
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Evaldas Girdauskas, Prof.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf
Locations
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Universitätsklinikum Augsburg
Augsburg, Bavaria, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Countries
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References
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Kubitz JC, Schulte-Uentrop L, Zoellner C, Lemke M, Messner-Schmitt A, Kalbacher D, Sill B, Reichenspurner H, Koell B, Girdauskas E. Establishment of an enhanced recovery after surgery protocol in minimally invasive heart valve surgery. PLoS One. 2020 Apr 9;15(4):e0231378. doi: 10.1371/journal.pone.0231378. eCollection 2020.
Petersen J, Kloth B, Konertz J, Kubitz J, Schulte-Uentrop L, Ketels G, Reichenspurner H, Girdauskas E. Economic impact of enhanced recovery after surgery protocol in minimally invasive cardiac surgery. BMC Health Serv Res. 2021 Mar 20;21(1):254. doi: 10.1186/s12913-021-06218-5.
Klotz SGR, Ketels G, Behrendt CA, Konig HH, Kohlmann S, Lowe B, Petersen J, Stock S, Vettorazzi E, Zapf A, Zastrow I, Zollner C, Reichenspurner H, Girdauskas E. Interdisciplinary and cross-sectoral perioperative care model in cardiac surgery: implementation in the setting of minimally invasive heart valve surgery (INCREASE)-study protocol for a randomized controlled trial. Trials. 2022 Jun 23;23(1):528. doi: 10.1186/s13063-022-06455-x.
Related Links
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Other Identifiers
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1564/108
Identifier Type: -
Identifier Source: org_study_id