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

Laparoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03329859
• Other study ID #: EK10/12
• Status: Completed
• Phase: N/A
• First received: October 30, 2017
• Last updated: October 30, 2017
• Start date: May 1, 2012
• Est. completion date: November 30, 2016

Study information

• Verified date: October 2017
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 30, 2016
• Est. primary completion date: June 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholecystectomy
• Costs
• Laparoscopy
• Workflow

Intervention

Procedure:
• High resolution standardized laparoscopic cholecystectomy
High resolution standardized laparoscopic cholecystectomy

Locations

Country	Name	City	State
Switzerland	University Hospital Basel/Dep. of General and Visceral Surgery	Basel	Basel Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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