This study aims to investigate the incidence and distribution of complications after different pelvic reconstruction surgeries using mesh/native tissue in multi-centers using the IUGA/ICS complication classification system(the Category-Time-Site(CTS) coding).
Patients who undergo different pelvic floor reconstructive surgeries for the cure of pelvic organ prolapse(POP)and/or stress urinary incontinence(SUI) between June 2018 and June 2023 from 27 tertiary hospitals are prospectively collected.Our study aims to follow-up and report the incidences of postoperative complications according to the International Urogynecological Association-International Continence Society(IUGA-ICS) Complication Classification Coding(Category-Time-Site coding system).The aimed pelvic floor reconstructive surgeries involve anterior,apical, posterior or total pelvic reconstruction with trans-vaginal mesh,open/laparoscopic sacrocolpopexy(Y-tape/self-cut synthesized mesh),repair using native tissue(sacrospinous ligament fixation, high uterosacral ligament suspension,ischial spinous fascia fixation, the Lefort operation and so on)and as well as anti-urinary incontinence surgeries(tension-free vaginal tape). Our follow-up process start after patients have completed the operation,thus our study do not affect patients' choice of surgical method.
Study Type
OBSERVATIONAL
Enrollment
13,120
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Beijing, Beiing, China
RECRUITINGThe frequency and incidence rate of different complications
Postoperative follow-up and record the occurrence of complications according to the International Urogynecological Association-International Continence Society(IUGA-ICS)Complication Classification Coding(Category-Time-Site coding system).
Time frame: at 6-week postoperatively
The frequency and incidence rate of different complications
Postoperative follow-up and record the occurrence of complications according to the International Urogynecological Association-International Continence Society(IUGA-ICS)Complication Classification Coding(Category-Time-Site coding system).
Time frame: at 3-month postoperatively
The frequency and incidence rate of different complications
Postoperative follow-up and record the occurrence of complications according to the International Urogynecological Association-International Continence Society(IUGA-ICS)Complication Classification Coding(Category-Time-Site coding system).
Time frame: at 1-year postoperatively
The frequency and incidence rate of different complications
Postoperative follow-up and record the occurrence of complications according to the International Urogynecological Association-International Continence Society(IUGA-ICS)Complication Classification Coding(Category-Time-Site coding system).
Time frame: at 2-year postoperatively
The frequency and incidence rate of different complications
Postoperative follow-up and record the occurrence of complications according to the International Urogynecological Association-International Continence Society(IUGA-ICS)Complication Classification Coding(Category-Time-Site coding system).
Time frame: up to 3-year postoperatively
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Anatomical cure rates in treated compartment of different pelvic reconstructive surgeries
The percentage of patients who reach the anatomical success criteria at each time point(6 weeks, 3 months and each year, up to 3-year postoperatively)
Time frame: 6 weeks, 3 months and each year, up to 3-year postoperatively
Change from Preoperative scores of POP-Q(Pelvic organ prolapse quantitation) at each follow-up
POP-Q is used for evaluation the severity(staging) of prolapse by pelvic examination preoperatively and postoperatively. The score is reported in cm. The changes from baseline scores at 6 weeks, 3 months, 1 year and up to 3 years postoperatively are respectively compared.
Time frame: Preoperatively; At 6weeks, 3 months, 1 year and assessed up to 3 year postoperatively.