Clinical trial NCT03617211: The Follow-up of Mesh/Native Tissue Complications Study(Part II)
Official title: A Multi-center Study: The Follow-up of Complications for Women Having Pelvic Reconstruction Surgery With Mesh/Native Tissue(Part II).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Organ Prolapse
Keywords: pelvic reconstructive surgery
mesh
native tissue
tape
complications
Category-time-site (CTS) coding
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Peking University People's Hospital
name: Qilu Hospital of Shandong University
name: Obstetrics & Gynecology Hospital of Fudan University，Shanghai Red House Obstetrics & Gynecology Hospital
name: Peking University Third Hospital
name: First Hospitals affiliated to the China PLA General Hospital
name: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
name: Tongji Hospital
name: The First Affiliated Hospital of Guangzhou Medical University
name: The First Affiliated Hospital with Nanjing Medical University
name: Wuxi Obsetrics & Gynecology Hospital
name: Fuzhou General Hospital
name: The First Affiliated Hospital of Jinan Hospital
name: Women's Hospital School Of Medicine Zhejiang University
name: Renmin Hospital of Wuhan University
name: The Third Hospital Affiliated Zhengzhou University
name: Shengjing Hospital
name: General Hospital of Ningxia Medical University
name: The Second Hospital of Hebei Medical University
name: Gansu Provincial Maternal and Child Health Care Hospital
name: First Affiliated Hospital of Xinjiang Medical University
name: Yantai Yuhuangding Hospital，Medical College, Qingdao University
name: Southwest Hospital, China
name: West China Second University Hospital
name: Jiangxi Maternal and Child Health Hospital
name: Chongqing Medical University
name: Shanxi Coal Central Hospital
First posted: 2018-08-06
Enrollment: 1530
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients are inferred to 27 tertiary hospitals with the complaint of de novo complications after pelvic reconstructive surgeries using mesh, tape and native tissue between June 2018 and June 2023. The subjects include patients who accept treatment not only at our participating hospitals but also from other hospital.And the date of surgeries carried is not restricted during the study period.

Brief summary: To study the incidence and distribution of complications after different pelvic reconstruction surgeries (mesh/native tissue) in multi-centers. The investigators aimed to report and summarize the postoperative complications diagnosed in the prior 1 year, 3 years and 5 years respectively, according to the International Urogynecological AssociationInternational Continence Society(IUGA-ICS) Complication Classification Coding(Category-Time-Site coding system) .

Detailed description: Patients are inferred to 27 tertiary hospitals with the complaint of de novo complications after pelvic reconstructive surgeries using mesh, tape and native tissue between June 2018 and June 2023. The subjects include patients who accept treatment not only at 27 participating hospitals but also from other hospital. And the date of surgeries carried is not restricted in the study period.

This is a study of real world. The researchers focus to investigate the incidence of complications in clinical practice.

Eligibility criteria: Inclusion Criteria:

* 1) Patients are inferred to the clinic with the complaint of de novo complications after pelvic reconstructive surgeries with mesh,tape or native tissue.
* 2) Pelvic reconstructive surgeries include but not limited to open/laparoscopic sacrocolpopexy (Y-shape tape/self-cut synthesized mesh), anterior, apical, posterior or total pelvic reconstruction with trans-vaginal mesh(commercial mesh kits or self-cut synthesized mesh), repair using native tissue(sacrospinous ligament fixation, high uterosacral ligament suspension, ischial spinous fascia fixation, the Lefort operation) and as well as anti-urinary incontinence surgeries(tension-free vaginal tape).
* 3) Both primary and repeated pelvic surgery are included.

Exclusion Criteria:

* If the same patient who developed complications after pelvic floor reconstructive surgeries has been diagnosed and reported in 27 participating hospitals, and again treated for "the same code complication in other 26 hospitals, she will be ruled out.

Primary outcomes:
measure: The frequency and ratio of different postoperative complications
timeFrame: 1-year;3-year;5-year
Secondary outcomes:
measure: The distribution of complications after each kind of pelvic reconstructive surgery
timeFrame: 1-year;3-year;5-year
measure: The percentage of various pelvic reconstructive surgeries under the same complication classification coding.
timeFrame: 1-year;3-year;5-year
Other outcomes:
Locations:
city: Beijing
country: China
facility: First Affiliated Hospital of PLA General Hospital (304)
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Wuxi
country: China
facility: Wuxi Obstetrics & Gynecology Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Obstetrics & Gynecology Hospital of Fudan University，Shanghai Red House Obstetrics & Gynecology Hospital
state: Shanghai
Study officials:
affiliation: Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
name: Lan Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References: