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| Name | Class |
|---|---|
| Peking University People's Hospital | OTHER |
| Qilu Hospital of Shandong University | OTHER |
| Obstetrics & Gynecology Hospital of Fudan University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic sacrocolpopexy(LSC) | Patients who prefer to accept laparoscopic sacrocolpopexy after hysterectomy. For patients who has desire of uterine-preservation,laparoscopic sacrocervicopexy or sacrohysteropexy is carried. | ||
| Reconstruction with transvaginal mesh(TVM) | Patients who undertake pelvic reconstruction with tran-vaginal mesh(commercial mesh kits or self-cut synthesized mesh). | ||
| Reconstruction with native tissue(NT) | Patients who prefer to accept reconstruction with native tissue,mainly including high uterosacral ligament suspension, sacrospinous ligament fixation,ischial spinous fascia fixation,the Lefort operation. | ||
| Tension-free vaginal tape surgery(TVT) | Patients who undertake anti-incontinence surgeries(tension-free vaginal tape procedure). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | 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). | 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). | up to 3-year postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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） | 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 |
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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:
2. The failure or recurrence of prolapse the same compartment that has been underwent repair using native tissue.
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuo Liang, MD | Contact | +8613718879529 | leahleung@foxmail.com | |
| Lan Zhu, MD | Contact | zhu_julie@vip.sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Lan Zhu, MD | Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences | Recruiting | Beijing | Beiing | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33443938 | Derived | Sun ZJ, Wang XQ, Lang JH, Xu T, Lu YX, Hua KQ, Han JS, Li HF, Tong XW, Wang P, Wang JL, Yang X, Huang XH, Liu PS, Song YF, Jin HM, Xie JY, Wang LW, Wu QK, Gong J, Wang Y, Wang LQ, Li ZA, Xu HC, Xia ZJ, Gu LN, Liu Q, Zhu L. A 14-year multi-institutional collaborative study of Chinese pelvic floor surgical procedures related to pelvic organ prolapse. Chin Med J (Engl). 2021 Jan 20;134(2):200-205. doi: 10.1097/CM9.0000000000001237. |
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| Peking University Third Hospital |
| OTHER |
| First Hospitals affiliated to the China PLA General Hospital | OTHER_GOV |
| Shanghai Jiao Tong University Affiliated Sixth People's Hospital | OTHER |
| Tongji Hospital | OTHER |
| The First Affiliated Hospital of Guangzhou Medical University | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| Wuxi Obsetrics & Gynecology Hospital | UNKNOWN |
| Fuzhou General Hospital | OTHER |
| First Affiliated Hospital of Jinan University | OTHER |
| Women's Hospital School Of Medicine Zhejiang University | OTHER |
| Renmin Hospital of Wuhan University | OTHER |
| Third Affiliated Hospital of Zhengzhou University | OTHER |
| Shengjing Hospital | OTHER |
| General Hospital of Ningxia Medical University | OTHER |
| The Second Hospital of Hebei Medical University | OTHER |
| Gansu Provincial Maternal and Child Health Care Hospital | OTHER |
| First Affiliated Hospital of Xinjiang Medical University | OTHER |
| Qingdao University | OTHER |
| Southwest Hospital, China | OTHER |
| West China Second University Hospital | OTHER |
| Jiangxi Maternal and Child Health Hospital | OTHER |
| Shanxi Coal Central Hospital | UNKNOWN |
| Chongqing Medical University | OTHER |
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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. |
| Preoperatively; At 6weeks, 3 months, 1 year and assessed up to 3 year postoperatively. |