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.

Study Overview

• Status: Completed
• Conditions: Gallstones
• Intervention / Treatment: Other: clinical pathway

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 241

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients undergoing elective laparoscopic cholecystectomy

Description

Inclusion Criteria:

• patients undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

• emergency procedures
• conversion to open cholecystectomy

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
check list; clinical pathway using a paper based check-list	Other: clinical pathway; implementation of a standardized clinical pathway
integrated clinical pathway; clinical pathway in form of a clinical pathway integrated into the paper based medical treatment and nursing documentation	Other: clinical pathway; implementation of a standardized clinical pathway

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compliance to clinical pathway	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	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complication	Complications assessed according to Clavien classification 30 days postoperative	30 days complication rate
total cost	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.	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)

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: December 8, 2015
• First Submitted That Met QC Criteria: January 25, 2016
• First Posted (Estimate): January 28, 2016

Study Record Updates

• Last Update Posted (Estimate): January 28, 2016
• Last Update Submitted That Met QC Criteria: January 25, 2016
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: cholecystectomy, check list
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Cholelithiasis; Cholecystolithiasis; Gallstones
• Other Study ID Numbers: ICP 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No