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OpenTrials
Completed

NCT Number: NCT02788331

Trends in Volume-Outcome Relationship in Surgery

The explanatory mechanism of the relationship between the volume of surgical procedures performed by individual hospitals and the occurrence of serious adverse events is not clear. Based on the " practice makes perfect " dogma, we will explore whether a learning effect can explain the volume-outcome relationship for complex surgical procedures using a nationwide dataset. Especially, we assume that increasing volume of procedures over time may be associated with improved outcomes.

Completed

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Key information

Conditions

Surgical Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon

Lyon, 69002, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

All adults hospitalized to have one of the following major surgery: resection of oeso-gastric, intestinal and pancreatic cancer, treatment of intra-abdominal aortic aneurysm, coronary artery bypass graft, endarterectomy, hip fracture prosthesis

Exclusion criteria

  • Hospitalization <24 hours
  • Absence of surgical procedure
  • Ambulatory care
  • Palliative care
  • Organ transplantation

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Inpatient mortality

    Time frame: Within 30 days of surgical procedure

Secondary outcomes

  1. Reoperation occurence

    Time frame: Within 30 days of surgical procedure

  2. Occurence of intensive or critical care unit stay

    Time frame: Within 30 days of surgical procedure

  3. Occurence of postoperative complication

    Time frame: Within 30 days of surgical procedure

    Postoperative complication includes sepsis, pulmonary embolism or deep vein thrombosis and cardiac arrest

  4. Occurence of unplanned hospital readmission

    Time frame: Within 30 days of hospital discharge related to index stay

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Revisiting the Volume-outcome Relationship in Surgery: Trends Analysis in French Hospitals

Acronym: TREVORS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 2, 2016
Registry last updated
Jun 19, 2017

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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