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Completed

NCT Number: NCT02569450

Evaluation of Control Chart Impact on Surgical Outcomes

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.

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Key information

Conditions

Digestive Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de Lyon, Pôle IMER

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical outcomes monitoring using Shewhart control chart

Behavioral
  • 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

Primary outcomes

  1. 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

  1. Occurrence of any death during hospitalization within 30 days of surgery

    Time frame: within 30 days following surgical procedure

  2. Occurrence of any complication during hospitalization within 30 days of surgery

    Time frame: at the end of hospitalization

  3. Occurrence of unplanned intensive care stay during hospitalization within 30 days of surgery

    Time frame: within 30 days following surgical procedure

  4. Occurrence of reoperation during hospitalization within 30 days of surgery

    Time frame: within 30 days following surgical procedure

  5. Number of hospital bed-days consumed

    Time frame: within 30 days following surgical procedure

  6. Hospitalization costs from a health insurance perspective

    Time frame: within 30 days following surgical procedure

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: SHEWHART

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 6, 2015
Registry last updated
Mar 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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