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

Study Overview
=================
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.

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

Conditions
-----------------
Gallstones

Intervention / Treatment
-----------------
* Other: clinical pathway


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing elective laparoscopic cholecystectomy Exclusion Criteria: emergency procedures conversion to open cholecystectomy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| check list<br>clinical pathway using a paper based check-list | Other: clinical pathway<br>* implementation of a standardized clinical pathway<br>|
| integrated clinical pathway<br>clinical pathway in form of a clinical pathway integrated into the paper based medical treatment and nursing documentation | Other: clinical pathway<br>* implementation of a standardized clinical pathway<br>|

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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cholecystectomy, check list