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

Study Overview
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Brief Summary
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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.

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

Conditions
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Workflow, Costs, Laparoscopy, Cholecystectomy

Intervention / Treatment
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* Procedure: High resolution standardized laparoscopic cholecystectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional arm<br>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. | Procedure: High resolution standardized laparoscopic cholecystectomy<br>* High resolution standardized laparoscopic cholecystectomy<br>|
| Active Comparator: Control arm<br>No 'High resolution standardized laparoscopic cholecystectomy' Patients in which laparoscopic cholecystectomy was performed in the conventional way without prior standardization | Procedure: High resolution standardized laparoscopic cholecystectomy<br>* High resolution standardized laparoscopic cholecystectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| median hourly delay due to microcomplications | 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. | Any microcomplications are recorded between skin incision to skin closure during laparoscopic cholecysectomy |