Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational study | Other | No intervention, observational only |
|
| Measure | Description | Time Frame |
|---|---|---|
| intraoperative complications according to ClassIntra® | All intraoperative complications are recorded and classified according to their severity | during surgery (intraoperatively) |
| Measure | Description | Time Frame |
|---|---|---|
| in-hospital postoperative complications | All postoperative complications observed during the hospital stay are recorded and classified according to their severity | From after surgery up to hospital discharge, timeframe up to 30 days |
| Duration of surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
All in-hospital patients (consecutive or random sample) undergoing surgery in the operating room with anaesthesia involvement
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Salome Dell-Kuster, MD MSc | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolinas Healthcare System | Charlotte | North Carolina | 28204 | United States | ||
| Northern Sydney Colorectal Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35177252 | Derived | Gawria L, Rosenthal R, van Goor H, Dell-Kuster S; ClassIntra Study Group. Classification of intraoperative adverse events in visceral surgery. Surgery. 2022 Jun;171(6):1570-1579. doi: 10.1016/j.surg.2021.12.011. Epub 2022 Feb 15. | |
| 32843333 | Derived | Dell-Kuster S, Gomes NV, Gawria L, Aghlmandi S, Aduse-Poku M, Bissett I, Blanc C, Brandt C, Ten Broek RB, Bruppacher HR, Clancy C, Delrio P, Espin E, Galanos-Demiris K, Gecim IE, Ghaffari S, Gie O, Goebel B, Hahnloser D, Herbst F, Ioannidis O, Joller S, Kang S, Martin R, Mayr J, Meier S, Murugesan J, Nally D, Ozcelik M, Pace U, Passeri M, Rabanser S, Ranter B, Rega D, Ridgway PF, Rosman C, Schmid R, Schumacher P, Solis-Pena A, Villarino L, Vrochides D, Engel A, O'Grady G, Loveday B, Steiner LA, Van Goor H, Bucher HC, Clavien PA, Kirchhoff P, Rosenthal R. Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study. BMJ. 2020 Aug 25;370:m2917. doi: 10.1136/bmj.m2917. |
Not provided
Not provided
Not provided
Not provided
Not provided
Time from start to end of the surgical procedure |
| From start to the end of the surgical procedure |
| Complexity of main surgical procedure | Complexity according to British United Provident Association (BUPA) classification | Baseline |
| in-hospital mortality | From after surgery up to hospital discharge, timeframe up to 30 days |
| 30-day mortality | 30 days postoperatively |
| Agreement in assessment of intraoperative complications between several raters using fictitious clinical case-scenarios using a questionnaire among physicians | Baseline |
| Sydney |
| Australia |
| Medical University of Innsbruck | Innsbruck | Austria |
| Barmherzige Brüder Krankenhaus | Vienna | Austria |
| Medical School, Aristotle University Thessaloniki | Thessaloniki | Greece |
| Trinity College Dublin at Tallaght | Dublin | Ireland |
| National Cancer Institute | Naples | Italy |
| Radboud University Medical Centre | Nijmegen | Netherlands |
| Auckland City Hospital | Auckland | New Zealand |
| Hospital Valle de Hebron | Barcelona | Spain |
| University Hopsital Basel | Basel | Canton of Basel-City | 4031 | Switzerland |
| University Childrens Hospital Basel | Basel | Switzerland |
| Kantonsspital Graubünden | Chur | Switzerland |
| University Hospital Lausanne | Lausanne | Switzerland |
| Bürgerspital Solothurn | Solothurn | Switzerland |
| Schulthess Clinique Zurich | Zurich | Switzerland |
| Ankara University Medical School | Ankara | Turkey (Türkiye) |
| Guy's and St. Thomas Hospital | London | United Kingdom |
| ID | Term |
|---|---|
| D007431 | Intraoperative Complications |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
Not provided
Not provided