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

Sponsor
University Hospital Tuebingen (Other)
Overall Status
Completed
CT.gov ID
NCT02667249
Collaborator
(none)
241
22

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
241 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Compliance of Clinical Pathways in Elective Laparoscopic Cholecystectomy: Evaluation of Different Implementation Methods
Study Start Date :
Aug 1, 2011
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. complication [30 days complication rate]

    Complications assessed according to Clavien classification 30 days postoperative

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patients undergoing elective laparoscopic cholecystectomy
Exclusion Criteria:
  • emergency procedures

  • conversion to open cholecystectomy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital Tuebingen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT02667249
Other Study ID Numbers:
  • ICP 001
First Posted:
Jan 28, 2016
Last Update Posted:
Jan 28, 2016
Last Verified:
Nov 1, 2015
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by University Hospital Tuebingen
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 28, 2016