Evaluation of Control Chart Impact on Surgical Outcomes

Completed

• Conditions: Digestive Surgery
• Interventions: Behavioral: Surgical outcomes monitoring using Shewhart control chart

• Registration Number: NCT02569450
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-05
• Study First Submitted QC: 2015-10-05
• Study First Posted: 2015-10-06
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-02
• Last Update Posted: 2022-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157594

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention arm	Surgical outcomes monitoring using Shewhart control chart	Hospitals randomly assigned to the intervention arm with surgical outcomes monitoring

Primary Outcome Measures

Name	Time	Method
Occurrence of any major adverse event during hospitalization	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 Outcome Measures

Name	Time	Method
Hospitalization costs from a health insurance perspective	within 30 days following surgical procedure
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
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

Trial Locations

Locations (1)

Hospices Civils de Lyon, Pôle IMER; 🇫🇷 Lyon, France