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

Completed

• Conditions: Gallstones
• Interventions: Other: clinical pathway

• Registration Number: NCT02667249
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

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.

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 Timeline

• Study Start: 2011-08
• Primary Completion: 2013-04
• Study Completion: 2013-06
• Status Verified: 2015-11
• Study First Submitted: 2015-12-08
• Study First Submitted QC: 2016-01-25
• Last Update Submitted: 2016-01-25
• Study First Posted: 2016-01-28
• Last Update Posted: 2016-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

Inclusion Criteria

• patients undergoing elective laparoscopic cholecystectomy

Exclusion Criteria

• emergency procedures
• conversion to open cholecystectomy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
integrated clinical pathway	clinical pathway	clinical pathway in form of a clinical pathway integrated into the paper based medical treatment and nursing documentation
check list	clinical pathway	clinical pathway using a paper based check-list

Primary Outcome Measures

Name	Time	Method
compliance to clinical pathway	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 Outcome Measures

Name	Time	Method
complication	30 days complication rate	Complications assessed according to Clavien classification 30 days postoperative
total cost	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.