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Validation Study of ClassIntra®
NCT03009929 · View on ClinicalTrials.gov ↗
Study Summary
Whereas there are several validated systems for reporting postoperative complications, there are only a few and not prospectively validated systems for reporting intraoperative complications. The investigators developed a definition and CLASSification for Intraoperative Complications CLASSIC within a Delphi study involving international interdisciplinary experts. As both surgery and anaesthesia may be involved in complications in the perioperative period, all patient-related intraoperative complications occurring between skin incision and closure are considered in this reporting system. CLASSIC was updated to ClassIntra® v1·0, by encompassing five severity grades to align with the validated Clavien-Dindo Classification for grading postoperative complications. The aim of this international multicentre observational cohort study is to assess the validity and practicability of this newly derived and updated classification system ClassIntra® in patient undergoing an in-hospital surgical procedure. Providing an easy applicable and internationally validated classification system is a contribution to improve quality of health care and patient safety.
Conditions Studied
Interventions
- OTHER Observational study
Study Locations (18)
Other
- Northern Sydney Colorectal Clinic — Sydney
- Medical University of Innsbruck — Innsbruck
- Barmherzige Brüder Krankenhaus — Vienna
- Medical School, Aristotle University Thessaloniki — Thessaloniki
- Trinity College Dublin at Tallaght — Dublin
- National Cancer Institute — Naples
- Radboud University Medical Centre — Nijmegen
- Auckland City Hospital — Auckland
- Hospital Valle de Hebron — Barcelona
- University Childrens Hospital Basel — Basel
- Kantonsspital Graubünden — Chur
- University Hospital Lausanne — Lausanne
- Bürgerspital Solothurn — Solothurn
- Schulthess Clinique Zurich — Zurich
- Ankara University Medical School — Ankara
- Guy's and St. Thomas Hospital — London
North Carolina
- Carolinas Healthcare System — Charlotte
Canton of Basel-City
- University Hopsital Basel — Basel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,500 participants |
| Start Date | 2017-02-15 |
| Est. Completion | 2018-08-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03009929
The ClinicalTrials.gov registry entry for NCT03009929 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Hospital, Basel, Switzerland, which has 10 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Postoperative Complications appearing as the primary indexed condition, and to 1 intervention — of which Observational study is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03009929 reports 18 study locations spanning 3 distinct geographic areas — top geographies include Other, North Carolina, Canton of Basel-City. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03009929 about?
NCT03009929 is a clinical study titled "Validation Study of ClassIntra®". Whereas there are several validated systems for reporting postoperative complications, there are only a few and not prospectively validated systems for reporting intraoperative complications. The investigators developed a definition and CLASSification for Intraoperative Complications CLASSIC within ...
What is the current status of trial NCT03009929?
This trial is currently completed. The enrollment target is 2,500 participants. The study started on 2017-02-15. Estimated completion is 2018-08-31.
What conditions does trial NCT03009929 study?
This clinical trial studies the following conditions: Postoperative Complications, Patient Safety, Intraoperative Complications, Risk Management. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03009929?
The interventions under investigation include: Observational study (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03009929?
This trial is sponsored by University Hospital, Basel, Switzerland, which has 10 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03009929 being conducted?
This trial has 18 study locations across North Carolina, Canton of Basel-City. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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