Clavien-Dindo, comprehensive complication index and classification of intraoperative adverse events

Clavien-Dindo, comprehensive complication index and classification of intraoperative adverse events: a uniform and holistic approach in adverse event registration for (deep) endometriosis surgery

Metzemaekers, Jeroen (Leiden University Medical Center)
Bouwman, Lotte (Leiden University Medical Center)
De Vos, Marit (Leiden University Medical Center)
Van Nieuwenhuizen, Kim (Leiden University Medical Center)
Twijnstra, A.R.H. (Leiden University Medical Center)
Smeets, Maddy (Leiden University Medical Center)
Jansen, F.W. (TU Delft Medical Instruments & Bio-Inspired Technology; Leiden University Medical Center)
Blikkendaal, Mathijs (Leiden University Medical Center)

2023

STUDY QUESTION: What is the additional value of the comprehensive complication index (CCI) and ClassIntra system (classification for intraoperative adverse events (ioAEs)) in adverse event (AE) reporting in (deep) endometriosis (DE) surgery compared to only using the Clavien-Dindo (CD) system? SUMMARY ANSWER: The CCI and ClassIntra are useful additional tools alongside the CD system for a complete and uniform overview of the total AE burden in patients with extensive surgery (such as DE), and with this uniform data registration, it is possible to provide greater insight into the quality of care. WHAT IS KNOWN ALREADY: Uniform comparison of AEs reported in the literature is hampered by scattered registration. In endometriosis surgery, the usage of the CD complication system and the CCI is internationally recommended; however, the CCI is not routinely adapted in endometriosis care and research. Furthermore, a recommendation for ioAEs registration in endometriosis surgery is lacking, although this is vital information in surgical quality assessments. STUDY DESIGN, SIZE, DURATION: A prospective mono-center study was conducted with 870 surgical DE cases from a nonuniversity DE expertise center between February 2019 and December 2021. PARTICIPANTS/MATERIALS, SETTING, METHODS: Endometriosis cases were collected with the EQUSUM system, a publicly available web-based application for registration of surgical procedures for endometriosis. Postoperative adverse events (poAEs) were classified with the CD complication system and CCI. Differences in reporting and classifying AEs between the CCI and the CD were assessed. ioAEs were assessed with the ClassIntra. The primary outcome measure was to assess the additional value toward the CD classification with the introduction of the CCI and ClassIntra. In addition, we report a benchmark for the CCI in DE surgery. MAIN RESULTS AND THE ROLE OF CHANCE: A total of 870 DE procedures were registered, of which 145 procedures with one or more poAEs, resulting in a poAE rate of 16.7% (145/870), of which in 36 cases (4.1%), the poAE was classified as severe (Grade 3b). The median CCI (interquartile range) of patients with poAEs was 20.9 (20.9-31.7) and 33.7 (33.7-39.7) in the group of patients with severe poAEs. In 20 patients (13.8%), the CCI was higher than the CD because of multiple poAEs. There were 11 ioAEs reported (11/870, 1.3%) in all procedures, mostly minor and directly repaired serosa injuries. LIMITATIONS, REASONS FOR CAUTION: This study was conducted at a single center; thus, trends in AE rates and type of AEs could differ from other centers. Furthermore, no conclusion could be drawn on ioAEs in relation to the postoperative course because the power of this database is not robust enough for that purpose. WIDER IMPLICATIONS OF THE FINDINGS: From our data, we would advise to use the Clavien-Dindo classification system together with the CCI and ClassIntra for a complete overview of AE registration. The CCI appeared to provide a more complete overview of the total burden of poAEs compared to only reporting the most severe poAEs (as with CD). If the use of the CD, CCI, and ClassIntra is widely adapted, uniform data comparison will be possible at (inter)national level, providing better insight into the quality of care. Our data could be used as a first benchmark for other DE centers to optimize information provision in the shared decision-making process.

adverse events
Clavien-Dindo
complications
deep endometriosis
endometriosis

http://resolver.tudelft.nl/uuid:21e4b745-8843-4c0b-b4dc-3181002fa33f

https://doi.org/10.1093/hropen/hoad019

Human Reproduction Open, 2023 (2)

Institutional Repository

journal article

© 2023 Jeroen Metzemaekers, Lotte Bouwman, Marit De Vos, Kim Van Nieuwenhuizen, A.R.H. Twijnstra, Maddy Smeets, F.W. Jansen, Mathijs Blikkendaal