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NCT03009929 · ClinicalTrials.gov registry record
Validation Study of ClassIntra®
A clinical trial of Postoperative Complications and Patient Safety, sponsored by University Hospital, Basel, Switzerland.
- Completed
- Registry status
- 2,500
- Enrollment target
- 18
- Study locations
NCT03009929 is a study of Postoperative Complications and Patient Safety that has completed, run by University Hospital, Basel, Switzerland. The registered enrollment target is 2,500 participants, above the 240-participant average among 17 other Postoperative Complications trials with a reported enrollment target (942% higher). The trial reports 18 study locations across 3 states.
The verdict
NCT03009929, a study of Postoperative Complications and Patient Safety, has completed, sponsored by University Hospital, Basel, Switzerland.
- COMPLETED
- Registry status
- 2,500 participants
- Enrollment target
- 18
- Study locations
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 |
Interested in This Trial?
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, categorized as an unspecified phase. The registered enrollment target is 2,500 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 240-participant average among 17 other Postoperative Complications trials with a reported enrollment target (942% higher). The listed sponsor is University Hospital, Basel, Switzerland, which has 12 total studies on file at ClinicalTrials.gov.
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.
NCT03009929 reports 18 study locations spanning 3 distinct geographic areas - top geographies include Other, North Carolina, Canton of Basel-City.
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.
What interventions are being tested in trial NCT03009929?
The interventions under investigation include: Observational study (OTHER).
Who is sponsoring clinical trial NCT03009929?
This trial is sponsored by University Hospital, Basel, Switzerland, which has 12 total clinical trials registered on ClinicalTrials.gov.
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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