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

NCT ID: NCT02667249

Last Updated: 2016-01-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 241 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-06-30

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.

Conditions

Gallstones

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

check list

clinical pathway using a paper based check-list

clinical pathway

Intervention Type: OTHER

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

clinical pathway

Intervention Type: OTHER

implementation of a standardized clinical pathway

Interventions

clinical pathway

implementation of a standardized clinical pathway

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patients undergoing elective laparoscopic cholecystectomy

Exclusion Criteria

• emergency procedures
• conversion to open cholecystectomy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ICP 001

Identifier Type: -

Identifier Source: org_study_id