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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02667249
Enrollment
241
Registered
2016-01-28
Start date
2011-08-31
Completion date
2013-06-30
Last updated
2016-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gallstones

Keywords

cholecystectomy, check list

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.

Interventions

implementation of a standardized clinical pathway

Sponsors

University Hospital Tuebingen
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* patients undergoing elective laparoscopic cholecystectomy

Exclusion criteria

* emergency procedures * conversion to open cholecystectomy

Design outcomes

Primary

MeasureTime frameDescription
compliance to clinical pathwaytime 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

MeasureTime frameDescription
complication30 days complication rateComplications assessed according to Clavien classification 30 days postoperative
total costtotal 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026