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OpenTrials
Completed

NCT Number: NCT02667249

Compliance of Clinical Pathways in Elective Laparoscopic Cholecystectomy: Evaluation of Different Implementation Methods

Compliance to the clinical pathway, postoperative complication and total cost of the hospitalisation of patients undergoing elective cholecystectomy for symptomatic cholecystolithiasis were collected over two different periods: using a clinical pathway in form of a paper based check-list (group 1, n=118) or a clinical pathway integrated into the paper based medical treatment and nursing documentation (group 2, n=123). Outcome measures were compliance of the clinical pathway and total costs per case.

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Key information

About this study

Data of patients undergoing elective cholecystectomy for symptomatic cholecystolithiasis were collected over two different periods: a clinical pathway in form of a paper based check-list (check-list group, n=118, or in form of a clinical pathway integrated into the paper based medical treatment and nursing documentation (integrated clinical pathway group, n=123. A standardized clinical pathway for elective laparoscopic cholecystectomy in form of a check list was initially established in 2008 and evaluated during a 6-month period (August 2011 until January 2012) at the University of Tuebingen. The integrated clinical pathway was evaluated during a 6-month period after an introduction phase of 2 months (November 2012 until April 2013). The contents of both clinical pathways were identical, especially concerning the standardization of perioperative fluid management, perioperative monitoring, nutrition, analgesia, reserve medications, preoperative and postoperative examinations, detailed laboratory blood testing, nursing standards and planned discharge.

Primary outcome measure was the compliance to the clinical pathway defined as an adherence of more than 80% to the presetted pathway items.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients undergoing elective laparoscopic cholecystectomy

Exclusion criteria

  • emergency procedures
  • conversion to open cholecystectomy

Treatment and study plan

Clinical Pathway

Other

implementation of a standardized clinical pathway

Primary outcomes

  1. compliance to clinical pathway

    Time frame: time period which is covered by the clinical pathway beginning from preclinical check up until final discharge after cholecystctomy (usually a time frame of 7-14 days)

    Compliance to clinical pathway defined as an adherence of more than 80% to the presetted pathway items as reported on a paper based check-list

Secondary outcomes

  1. complication

    Time frame: 30 days complication rate

    Complications assessed according to Clavien classification 30 days postoperative

  2. total cost

    Time frame: total cost of the hospitalization covering the period from preclinical check up until final discharge after cholecystctomy (usually a time frame of 7-14 days)

    total costs per case covering the period from preclinical check up until final and discharge after cholecystctomy (€) were assessed using our prospective. electronic patient and quality assessment data base. Costs were calculated according to our internal transfer prices.

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 28, 2016
Registry last updated
Jan 28, 2016

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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