Microcomplications in Lap. Cholecystectomy: Reducing Intraoperative Interruptions by High Resolution Standardization

NCT03329859 — Not applicable, Completed, 39 participants, University Hospital, Basel, Switzerland

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Impact of Microcomplications in Laparoscopic Surgery on Operative Time and Costs - Multimodal Strategy to Reduce Microcomplications

Registry	NCT03329859
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, sequential, masking: none, health services research
Enrollment	39 (Actual)
Sponsor	University Hospital, Basel, Switzerland (Other)
Conditions	Workflow, Costs, Laparoscopy, Cholecystectomy
Interventions	High resolution standardized laparoscopic cholecystectomy (Procedure)
Dates	start 2012-05-01, primary completion 2015-06-30, completion 2016-11-30, first posted 2017-11-06, last updated 2017-11-06
Locations	1 site in Switzerland

-Summary

Objective: Investigators aimed to evaluate the impact of a high resolution standardized laparoscopic (HRSL) cholecystectomy protocol on operative time and intraoperative interruptions in a teaching hospital.

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Interventional arm	Experimental	Procedure: High resolution standardized laparoscopic cholecystectomy	"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.
Control arm	Active comparator	Procedure: High resolution standardized laparoscopic cholecystectomy	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 (Procedure): High resolution standardized laparoscopic cholecystectomy

+Outcome measures

Primary outcomes

median hourly delay due to microcomplications [Any microcomplications are recorded between skin incision to skin closure during laparoscopic cholecysectomy]: median hourly increase in operative time in seconds due to microcomplications before and after an intervention to reduce microcomplications. Microcomplications are defined as any interruption of the surgical workflow.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* age above and including 18 years
* indication for laparoscopic cholecystectomy
* written informed consent of patient
* written informed consent of the operating team

Exclusion Criteria:

* age below 18 years
* other laparoscopic or open surgical procedure in the same operation.

+Locations (1)

Facility	City	Country	Status
University Hospital Basel/Dep. of General and Visceral Surgery	Basel, Canton of Basel-City	Switzerland

+Publications

Results publication: 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. PMID 29785458

+Investigators

Marco von Strauss und Torney, MD, Principal investigator, University Hospital Basel, Department of General and Visceral Surgery, Spitalstrasse 21, CH-4031 Basel