Pelvic Floor
Conditions
Keywords
Pelvic floor reconstructive surgery, Mesh, Native tissue, Tape, Complication, the CTS coding
Brief summary
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).
Detailed description
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.
Interventions
None listed
Sponsors
Peking University People's Hospital
Qilu Hospital of Shandong University
Obstetrics & Gynecology Hospital of Fudan University，Shanghai Red House Obstetrics & Gynecology Hospital
Peking University Third Hospital
First Hospitals affiliated to the China PLA General Hospital
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Tongji Hospital
The First Affiliated Hospital of Guangzhou Medical University
The First Affiliated Hospital with Nanjing Medical University
Wuxi Obsetrics & Gynecology Hospital
Fuzhou General Hospital
The First Affiliated Hospital of Jinan Hospital
Women's Hospital School Of Medicine Zhejiang University
Renmin Hospital of Wuhan University
The Third Hospital Affiliated Zhengzhou University
Shengjing Hospital
General Hospital of Ningxia Medical University
The Second Hospital of Hebei Medical University
Gansu Provincial Maternal and Child Health Care Hospital
First Affiliated Hospital of Xinjiang Medical University
Yantai Yuhuangding Hospital，Medical College, Qingdao University
Southwest Hospital, China
West China Second University Hospital
Jiangxi Maternal and Child Health Hospital
Shanxi Coal Central Hospital
Chongqing Medical University
Peking Union Medical College Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
\- 1. Patients who undergo pelvic floor reconstructive surgeries for pelvic organ prolapse and/or stress urinary incontinence. The aimed pelvic floor reconstructive surgeries involve anterior, apical, posterior or total pelvic reconstruction with trans-vaginal mesh, open/laparoscopic sacrocolpopexy (Y-shape 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). The indications are respectively as follows: 1. Total pelvic reconstruction with trans-vaginal mesh Indications: 1) Patients experienced recurrence of prolapse in the same compartment that has a history of pelvic floor repair surgery; 2) The choice for elder patients who will accept primary surgery for advanced POP (staging III or IV). 2. Open/Laparoscopic sacrocolpopexy (Y-shape tape/self-cut synthesized mesh) Indications: 1) Presenting with at least 3 prolapse of the uterus, with or without concomitant cystocele and rectocele; 2) Symptomatic stage 2 or greater prolapse of the vaginal vault or apical recurrence. 3. Repair using native tissue(sacrospinous ligament fixation, high uterosacral ligament suspension, ischial spinous fascia fixation, Lefort) Indications:1)Presenting symptomatic stage 2 or greater prolapse of the uterus, with or without concomitant cystocele and rectocele. The procedure(sacrospinous ligament fixation, high uterosacral ligament suspension, ischial spinous fascia fixation) usually is performed after hysterectomy or when the uterus is preserved. 2)If postmenopausal women present with advanced uterus or vaginal apex prolapse, and have no desire of sexual life, the Lefort operation would be performed. 4. Anti-urinary incontinence surgeries: tension-free vaginal tape. Indications: Stress urinary incontinence(SUI) patients who have 1）hyperactivity of urethra, or 2）internal urethral sphincter disorder; Or 3）mainly presenting SUI symptoms in patients with mixed urinary incontinence. 2\. The failure or recurrence of prolapse the same compartment that has been underwent repair using native tissue.
Exclusion criteria
* (1) the recurrence occurred on the same pelvic compartment with a prior history of prolapse repair surgery using mesh, an implant or a graft; (2) a prior history of anti-incontinence surgery using tape; however, patients who are inferred to accept procedures for POP this time are not included; (3) acute/chronic pelvic inflammation, genital tract infections；(4) any severe medical diseases that precluded the operations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The frequency and incidence rate of different complications | at 6-week postoperatively | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anatomical cure rates in treated compartment of different pelvic reconstructive surgeries | 6 weeks, 3 months and each year, up to 3-year postoperatively | 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） |
| Change from Preoperative scores of POP-Q(Pelvic organ prolapse quantitation) at each follow-up | Preoperatively; At 6weeks, 3 months, 1 year and assessed up to 3 year postoperatively. | 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. |
Countries
China
Contacts
Primary ContactShuo Liang, MD
Backup ContactLan Zhu, MD
Outcome results
None listed