The Pelvic Floor Complication Scale: a new instrument for reconstructive pelvic surgery

Abstract

Objective To develop and test a unique, new pelvic floor surgery complication scale and compare it to an existing validated measure. Study Design Surgeons from two clinical trials networks rated complications based on perceived patient bother, severity, and duration of disability to develop a pelvic floor complication scale (PFCS). PFCS scores were calculated for subjects in two multicenter pelvic floor surgical trials. The PFCS and modified Clavien-Dindo scores were evaluated for associations with length of hospitalization(LOH), satisfaction, and quality-of-life (QoL) measures {Health Utilities Index(HUI), Short Form-36(SF-36), Urogenital Distress Inventory(UDI) and Incontinence Impact Questionnaire(IIQ)}. Results We calculated PFCS scores for 977 subjects. Higher PFCS and Clavien-Dindo scores were similarly associated with longer LOH (p<0.01), lower satisfaction (p<0.01); lower HUI (p=0.02), lower SF-36 (p=0.02), higher UDI (p<0.01) and IIQ (p<0.01) scores at 3 months. No associations were present at 1 year. Conclusion The PFCS compares favorably to the validated modified Clavien-Dindo instrument.

Systematic assessment of surgical complications in 438 cases of vaginal native tissue repair for pelvic organ prolapse adopting Clavien–Dindo classification

“…Unlike previous studies [12], our analysis specifically focused on criteria that were directly related to the surgical technique and surgical wounds rather than on mid-or long-term outcomes after pelvic floor surgery. With regards to the relatively elderly age of patients with POP and to the quality of life consequences, the decision as to perform surgical or conservative treatment should be made considering the complications that are inherent to the different surgical techniques.…”

The effect of vaginal pelvic organ prolapse surgery on sexual function

“…Furthermore, “success” may have to include complication parameters, in addition to objective, subjective and functional outcomes. Development of a pelvic floor complication scale might pave the way for a composite outcome score …”

Gaining the patient perspective on pelvic floor disorders’ surgical adverse events

“…Most IRBs, which provide oversight for surgical trials, implement and use similar language as that used by the FDA for AEs. 6,7 In routine clinical care, established classifications of perioperative complications are used, such as the Clavien-Dindo scale, 8,9 which was validated in the general surgical population and the Pelvic Floor Complication Scale, 10 which is a more condition-specific classification system for AEs from pelvic reconstructive surgery.…”