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

NCT03329859 | Completed

• 1 other identifier: EK10/12
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Workflow; Costs; Laparoscopy; Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Interventional arm

EXPERIMENTAL

"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

Control arm

ACTIVE COMPARATOR

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

Interventions

High resolution standardized laparoscopic cholecystectomy PROCEDURE

High resolution standardized laparoscopic cholecystectomy

Control arm; Interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age above and including 18 years
• indication for laparoscopic cholecystectomy
• written informed consent of patient
• written informed consent of the operating team

You may not qualify if:

• age below 18 years
• other laparoscopic or open surgical procedure in the same operation.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel/Dep. of General and Visceral Surgery

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (1)

• von Strauss Und Torney M, Aghlmandi S, Zeindler J, Nowakowski D, Nebiker CA, Kettelhack C, Rosenthal R, Droeser RA, Soysal SD, Hoffmann H, Mechera R. High-resolution standardization reduces delay due to workflow disruptions in laparoscopic cholecystectomy. Surg Endosc. 2018 Dec;32(12):4763-4771. doi: 10.1007/s00464-018-6224-y. Epub 2018 May 21.

  PMID: 29785458 DERIVED

Study Officials

• Marco von Strauss und Torney, MD

  University Hospital Basel, Department of General and Visceral Surgery, Spitalstrasse 21, CH-4031 Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 6, 2017
• Study Start: May 1, 2012
• Primary Completion: June 30, 2015
• Study Completion: November 30, 2016
• Last Updated: November 6, 2017

Record last verified: 2017-10

Locations

CH (1)