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

NCT02667249 | Completed

• 1 other identifier: ICP 001
• Study Type: observational
• Target: 241
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gallstones

Keywords

cholecystectomy, check list

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• complication

  30 days complication rate

• 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)

Study Arms (2)

check list

clinical pathway using a paper based check-list

Other: 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

Interventions

clinical pathway OTHER

implementation of a standardized clinical pathway

check list; integrated clinical pathway

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients undergoing elective laparoscopic cholecystectomy

You may qualify if:

• patients undergoing elective laparoscopic cholecystectomy

You may not qualify if:

• emergency procedures
• conversion to open cholecystectomy

Sponsors & Collaborators

• University Hospital Tuebingen: lead

MeSH Terms

Conditions

Gallstones

Interventions

Critical Pathways

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: January 28, 2016
• Study Start: August 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 28, 2016

Record last verified: 2015-11

Data Sharing

• IPD Sharing: Will not share