Classification of mesh complications It’s time for a new patient-centred classification system, practical for clinical use
a year). S (site) establishes that the least severe complication involves the anatomical site into which it was inserted (vaginal complications S1, S2). Surrounding anatomical structures involved will be S3 (trocar passage related), S4 (not associated with trocar skin or musculoskeletal complications) and S5 (intraabdominal complications). S0 (Systemic complications with no specific site) (Figure 1). The classification system replaced the term ‘‘erosion’’ with more specific terms for clarity. The new proposed terms are Contraction (shrinkage), Prominence (protrusion, with no epithelial separation), Separation, Exposure (mesh visualisation), Extrusion (gradual exposure), Perforation (opening into a hollow organ), Dehiscence (open along sutured lines), and Sinus tract formation (fistulous tract). It also determines that all complications should be listed and reported separately, and if there is a progression over time, the highest category should be used. "However, the classification system has also been criticised for being cumbersome for clinical use and more suitable for research." The system translates complex clinical findings into organised descriptions, including essential details for treatment planning. It also gives surgeons a well-characterised understanding of potential complications, which is advantageous in preoperative counselling. In addition, the CTS standardises communication, making it suitable for surgical audits, complication registries, and publications. Usability in the real world? After its publication, several groups assessed the usability of the ICS/IUGA CTS system in academic and clinical practice. The applicability and reliability of the system have been proven [10, 11]. However, the system has also been criticised for being cumbersome for clinical use and more suitable for research [12]. A large number of variables makes it difficult to compare subgroups, and interobserver variability has also been demonstrated [13]. Batalden et al. [12] argue that 30% of their cases could not be retrospectively coded in an academic tertiary care referral hospital with Female Pelvic Medicine and Reconstructive Surgery board-certified surgeons. In the same study, the authors concluded that the CTS classification did not predict treatment or outcome, while patient symptoms predicted both. Several publications recommend altering the system to include common functional disorders such as voiding dysfunction and, de novo overactive bladder [11, 12]. Petri et al. [14] also suggested that rare complications like dyspareunia of the partner, urine loss during intercourse, and foreign body sensation may be placed in the miscellaneous category. The CTS system is also considered doctor- centred since patient satisfaction is not included in the classification [12]. "Over 92,000 women in England, complications have been reported in 9.8% of cases at 5 years [4]." Another problem with the classification system is that it does not specify the type of mesh. Some patients may have more than one mesh with multiple complications, for example, more than one extrusion or exposure. In 2013 Gutman et al. [15] published a pelvic floor complication scale (PFCS). They aimed to develop a tool for assessing peri and postoperative complications specific to pelvic
Dr. Carolina Ochoa Vargas Consultant Urological Surgeon, Bristol Urological Institute, Bristol (GB)
carolina.ochoavargas@ gmail.com
Prof. Hashim Hashim
Consultant Urological Surgeon & Director of the Urodynamics Unit, Bristol Urological Institute, Bristol (GB)
h.hashim@ gmail.com
Figure 1. International Continence Society/International Urogynecological Association classification system, see www.ics.org.
The use of synthetic material in female pelvic floor surgery over the last 30 years has been significant. In the 1990’s, tension-free retropubic sub-urethral synthetic tapes/slings for stress urinary incontinence (SUI) were introduced [1]. Following that, the transobturator tapes (TOT) and single-incision slings were introduced [2]. The use of mesh for vaginal prolapse surgery has also spread as it achieved anatomical efficacy with a 29% risk reduction of recurrence [3]. However, most of these trials did not report long-term complications. In a retrospective study of over 92,000 women in England, complications have been reported in 9.8% of cases at 5 years [4]. Complications can either be mesh related, such as infection and healing abnormalities [5] and/or procedural-related, such as during insertion. A wide range of complications have been reported, such as mesh exposure (2.7–4.4%), voiding dysfunction requiring surgery in 3%, urinary tract infections (UTIs) in 10.7–17.1%, neurological symptoms in 5.4–9.7% [6] chronic pain in 4.5% up to 9% [7], bowel related problems and even systemic complications [8]. "The classification system translates complex clinical findings into organised descriptions, standardising communication." In 2011, due to the uniqueness of the complications, the International Continence Society (ICS) and the International Urogynecological Association (IUGA), jointly established a classification system based on the category, time and site (CTS) [9]. The purpose was to standardise the language and increase awareness of complications following female pelvic floor procedures using prostheses and grafts in pelvic surgery. The secondary aim was to support the creation of a registry of complications to inform and guide surgeons, patients, and the industry. This registry, known as CTS Classification, incorporates a vast range of clinical scenarios into a numerical and ordinal code so that no additional descriptors are necessary. How CTS Classification works The CTS system describes a complication according to its anatomical site and severity involving three (or four) letters and three numerals. C stands for category [1 to 7]. The first three are vaginal complications from no exposure to more than 1 cm. Categories 4 and 5 include perforation into the urinary tract, rectal or bowel accordingly. Category 6 includes musculoskeletal complications (fistula); the last one, 7, includes systemic complications. Next to the number will be a capital letter (A-D). A: Asymptomatic, B: Symptomatic, C: Infection, D: Abscess. A subclassification for pain is also included in the system, with a lowercase letter ‘a’ being no pain to ‘e’ being spontaneous pain. The time (T) is when the complication is clinically diagnosed, starting from T1 (48 h) to T4 (over
reconstructive surgery (prolapse and urinary incontinence). The investigators rated specific intraoperative plus immediate and delayed postoperative complications on a scale from 0 to 10 based on severity, patient bothers, and duration of the disability. They compared their system with the Clavien-Dindo classification system. They concluded that PFCS could reflect complications specific to pelvic floor surgery. However, despite being specific for pelvic floor surgery, this scale includes non-mesh procedures. Moreover, it still needs to be validated. Conclusion In summary, the CTS is the most currently available specific mesh-related complications classification system. However, there is a need
for a new classification system, which ideally would be patient-centred, adequately describe the complication, and be agile enough to use in clinical practice. In addition, it needs to include associated symptoms, e.g. bowel and bladder, and functional disorders may enhance the ability to use it in counselling and management.
References are available on request from the authors.
Sunday, 12 March 14:12 - 14:17 EAU Guidelines Session: Non-neurogenic female LUTS Yellow Area, eURO Auditorium 2
Opening Ceremony & Networking Reception
Opening and welcome by Professor C. Chapple
EAU Ernest Desnos Prize 2023
EAU Prostate Cancer Research Award 2023 Supported by the FRITZ H. SCHRODER FOUNDATION
Announcement of the new EAU Honorary Members
EAU Patient Advocacy Medal of Excellence 2023
Special EAU Award presentations
EAU Willy Gregoir Medal 2023
Plus live performances.
EAU Frans Debruyne Life Time Achievement Award 2023
Please join us after the Opening Ceremony for the Networking Reception which will give all delegates the opportunity to renew ties with colleagues from all over the world.
EAU Crystal Matula Award 2023 Supported by LABORIE
EAU Hans Marberger Award 2023 Supported by KARL STORZ SE & CO.KG
EAU Innovators in Urology Award 2023
You are invited!
Friday, 10 March Yellow Area: eURO Auditorium 1 18.00 - 19.30 hrs Opening Ceremony followed by a Networking Reception in the foyer
European Urology Today
16
February/March 2023
Powered by FlippingBook