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

Not Applicable

Completed

• Conditions: Workflow; Costs; Laparoscopy; Cholecystectomy
• Interventions: Procedure: High resolution standardized laparoscopic cholecystectomy

• Registration Number: NCT03329859
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-01
• Primary Completion: 2015-06-30
• Study Completion: 2016-11-30
• Status Verified: 2017-10
• Study First Submitted: 2017-10-30
• Study First Submitted QC: 2017-10-30
• Last Update Submitted: 2017-10-30
• Study First Posted: 2017-11-06
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Control arm	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
Interventional arm	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Hospital Basel/Dep. of General and Visceral Surgery; 🇨🇭 Basel, Basel Stadt, Switzerland