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

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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Key information

Conditions

Workflow Cholecystectomy Costs Laparoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel/Dep. of General and Visceral Surgery

Basel, Canton of Basel-City, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High resolution standardized laparoscopic cholecystectomy

Procedure

High resolution standardized laparoscopic cholecystectomy

Primary outcomes

median hourly delay due to microcomplications

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2016
First posted: Nov 6, 2017
Registry last updated: Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed