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

October 30, 2017 updated by: University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Basel Stadt
      • Basel, Basel Stadt, Switzerland, 4031
        • University Hospital Basel/Dep. of General and Visceral Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional arm
"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
High resolution standardized laparoscopic cholecystectomy
Active Comparator: Control arm
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
High resolution standardized laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Any microcomplications are recorded between skin incision to skin closure during laparoscopic cholecysectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Marco von Strauss und Torney, MD, University Hospital Basel, Department of General and Visceral Surgery, Spitalstrasse 21, CH-4031 Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2012

Primary Completion (Actual)

June 30, 2015

Study Completion (Actual)

November 30, 2016

Study Registration Dates

First Submitted

October 30, 2017

First Submitted That Met QC Criteria

October 30, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

October 30, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • EK10/12

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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