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

University Hospital Basel

Status: Completed

Conditions: Cholecystectomy; Laparoscopy; Costs; Workflow

Treatments: Procedure: High resolution standardized laparoscopic cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03329859

EK10/12

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

Interventional arm

Experimental group

Description:

"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.

Treatment:

Procedure: High resolution standardized laparoscopic cholecystectomy

Control arm

Active Comparator group

Description:

No 'High resolution standardized laparoscopic cholecystectomy' Patients in which laparoscopic cholecystectomy was performed in the conventional way without prior standardization

Treatment:

Procedure: High resolution standardized laparoscopic cholecystectomy