The Impact of Surgical Outcomes Monitoring Using Control Chart on Surgical Performance: A Cluster Randomized Trial

Hospices Civils de Lyon1 site in 1 country157,594 target enrollmentOctober 2015

ConditionsDigestive Surgery

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Digestive Surgery
Sponsor: Hospices Civils de Lyon
Enrollment: 157594
Locations: 1
Primary Endpoint: Occurrence of any major adverse event during hospitalization
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This two arms parallel cluster-randomized trial will evaluate the impact of monitoring surgical outcomes using Shewhart control chart (intervention) on the occurence of major adverse events, among a large sample of French surgical departments. Trends in surgical outcomes before and after the intervention will be compared between arms.

Registry

clinicaltrials.gov

Start Date

October 2015

End Date

December 31, 2018

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hospices Civils de Lyon

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All adults needing a digestive surgery who are hospitalized in one of the 40 departments

Exclusion Criteria

•Age \< 18 years old
•Hospitalization \<24 hours
•Absence of surgical procedure
•Ambulatory care
•Palliative care
•Organ transplantation

Outcomes

Primary Outcomes

Occurrence of any major adverse event during hospitalization

Time Frame: within 30 days following surgical procedure

Major adverse events include postoperative death, complication, unplanned intensive care stay or reoperation within 30 days of surgery.

Secondary Outcomes

Occurrence of reoperation during hospitalization within 30 days of surgery(within 30 days following surgical procedure)
Number of hospital bed-days consumed(within 30 days following surgical procedure)
Hospitalization costs from a health insurance perspective(within 30 days following surgical procedure)
Occurrence of any death during hospitalization within 30 days of surgery(within 30 days following surgical procedure)
Occurrence of unplanned intensive care stay during hospitalization within 30 days of surgery(within 30 days following surgical procedure)
Occurrence of any complication during hospitalization within 30 days of surgery(at the end of hospitalization)