Skip to content

Evaluation of Control Chart Impact on Surgical Outcomes

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02569450
Acronym
SHEWHART
Enrollment
157594
Registered
2015-10-06
Start date
2015-10-31
Completion date
2018-12-31
Last updated
2022-03-17

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

Conditions

Digestive Surgery

Keywords

Surgery, Performance, Outcome, Control chart

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.

Interventions

BEHAVIORALSurgical outcomes monitoring using Shewhart control chart

* Assistance by a local surgeon responsible for the implementation of intervention within his/her department * Quarterly team meeting to interpret variations in observed outcomes on the control charts * Restitution of surgical outcomes based on wall posters in operating room * Training sessions provided to local surgeon for appropriate control chart utilization

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of any major adverse event during hospitalizationwithin 30 days following surgical procedureMajor adverse events include postoperative death, complication, unplanned intensive care stay or reoperation within 30 days of surgery.

Secondary

MeasureTime frame
Occurrence of any complication during hospitalization within 30 days of surgeryat the end of hospitalization
Occurrence of unplanned intensive care stay during hospitalization within 30 days of surgerywithin 30 days following surgical procedure
Occurrence of any death during hospitalization within 30 days of surgerywithin 30 days following surgical procedure
Number of hospital bed-days consumedwithin 30 days following surgical procedure
Hospitalization costs from a health insurance perspectivewithin 30 days following surgical procedure
Occurrence of reoperation during hospitalization within 30 days of surgerywithin 30 days following surgical procedure

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026