Microcomplications in Lap. Cholecystectomy: Reducing Intraoperative Interruptions by High Resolution Standardization
NCT ID: NCT03329859
Last Updated: 2017-11-06
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
39 participants
INTERVENTIONAL
2012-05-01
2016-11-30
Brief Summary
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Background: Interruptions of the surgical workflow or microcomplications (MC) lead to prolonged procedure times and costs and can be indicative for surgical mistakes. Reducing MC can improve operating room efficiency and prevent intraoperative complications.
Methods: Audio video records of laparoscopic cholecystectomies were reviewed regarding type, frequency and duration of MC before and after the implementation of a HRSL which included the introduction of a stepwise protocol for the procedure and a teaching video. After consent operating team members were obliged to prepare the operation with these resources.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Interventional arm
"High resolution standardized laparoscopic cholecystectomy" Patients in which laparoscopic cholecystectomy was performed after high Resolution standardization and Training of the OR Team according to the Standard.
High resolution standardized laparoscopic cholecystectomy
High resolution standardized laparoscopic cholecystectomy
Control arm
No 'High resolution standardized laparoscopic cholecystectomy' Patients in which laparoscopic cholecystectomy was performed in the conventional way without prior standardization
High resolution standardized laparoscopic cholecystectomy
High resolution standardized laparoscopic cholecystectomy
Interventions
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High resolution standardized laparoscopic cholecystectomy
High resolution standardized laparoscopic cholecystectomy
Eligibility Criteria
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Inclusion Criteria
* indication for laparoscopic cholecystectomy
* written informed consent of patient
* written informed consent of the operating team
Exclusion Criteria
* other laparoscopic or open surgical procedure in the same operation.
18 Years
ALL
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Marco von Strauss und Torney, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Basel, Department of General and Visceral Surgery, Spitalstrasse 21, CH-4031 Basel
Locations
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University Hospital Basel/Dep. of General and Visceral Surgery
Basel, Canton of Basel-City, Switzerland
Countries
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References
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von Strauss Und Torney M, Aghlmandi S, Zeindler J, Nowakowski D, Nebiker CA, Kettelhack C, Rosenthal R, Droeser RA, Soysal SD, Hoffmann H, Mechera R. High-resolution standardization reduces delay due to workflow disruptions in laparoscopic cholecystectomy. Surg Endosc. 2018 Dec;32(12):4763-4771. doi: 10.1007/s00464-018-6224-y. Epub 2018 May 21.
Other Identifiers
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EK10/12
Identifier Type: -
Identifier Source: org_study_id