Clinical trial NCT04025047: A Multi-center Registry Study: The Follow-up the Complications for Trans-vaginal Mesh Surgery
Official title: A Multi-center Registry Study: The Complications After Women Having Pelvic Reconstruction Surgery With Trans-vaginal Mesh
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pelvic Organ Prolapse
Keywords: trans-vaginal mesh
pelvic reconstruction surgery
complications
the CTS(category-time-site) coding system
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Qilu Hospital of Shandong University
name: The First Affiliated Hospital of Nanchang University
name: Jiangxi Maternal and Child Health Hospital
name: Fuzhou General Hospital
name: Obstetrics & Gynecology Hospital of Fudan University
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
name: Affiliated Wuhu Clinical College of Nantong University
name: The Second Hospital of Anhui Medical University
name: Renmin Hospital of Wuhan University
name: Second Xiangya Hospital of Central South University
name: Changsha Hospital for Maternal and Child Health Care
name: The Third Xiangya Hospital of Central South University
name: Wuhan Union Hospital, China
name: Shenzhen People's Hospital
name: Fourth Medical Center of PLA General Hospital
name: Beijing Chao Yang Hospital
name: The Second Affiliated Hospital of Harbin Medical University
name: Second Hospital of Jilin University
name: Shengjing Hospital
name: Yantai Yuhuangding Hospital
name: Shanxi Coal Center Hospital
name: Mianyang Central Hospital
name: West China Second University Hospital
name: Chongqing Medical Center for Women and Children
name: Southwest Hospital, China
name: Shaanxi Provincial People's Hospital
name: First Affiliated Hospital of Xinjiang Medical University
name: People's Hospital of Xinjiang Uygur Autonomous Region
name: Dalian Maternity and Child Care Hospital
name: Henan Provincial People's Hospital
name: Shanghai 10th People's Hospital
name: Shanghai First Maternity and Infant Hospital
name: Nanjing Maternity and Child Health Care Hospital
name: Affiliated Renhe Hospital of China Three Gorges University, China
name: Guizhou Provincial People's Hospital
name: The First Affiliated Hospital of the Medical College, Shihezi University，China
name: Yangpu District Central Hospital Affiliated to Tongji University
name: Wuhan Central Hospital
First posted: 2019-07-18
Enrollment: 4147
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women who prefer to undertake pelvic reconstruction surgery with trans-vaginal mesh for 1) a newly diagnosed severe POP: at least stage III (ICS-classification according to POP-Q system) in one or more compartments; 2) The failure or recurrence after pelvic floor reconstruction with native-tissue(symptomatic II and above).

Brief summary: This is a multi-center, prospective, observational, hospital-based registry of pelvic organ prolapse(POP) patients who having trans-vaginal mesh implantation with 12 month and 36 month follow-up.To investigate the incidence of postoperative complications according to the International Urogynecological Association/International Continence Society (IUGA/ICS) complication classification system(the Category- Time-Site(CTS) coding).

Detailed description: Patients who undergo pelvic floor reconstructive surgery with trans-vaginal mesh for the cure of pelvic organ prolapse (POP) between June 2019 and December 2022 from 41 centers across the country are going to be prospectively collected. The study is designed to report the clinical data，outcomes and complications of transvaginal mesh surgery in China. The information gathered will identify the incidence rate of complications, especially mesh exposure/erosion, in Chinese women and whether published, professional guidelines on POP surgical treatment as well as mesh complications management are being applied appropriately. Findings from this registry may help in knowing the current status of transvaginal mesh use in China as well as identify issues that may affect the surgical outcome and complications occurrence. Based on the registry study, clinical practice on the management of transvaginal mesh implantation including selection patients, pre- and post-operative evaluation and complications surgical database will be established.

The follow-up process starts after patients have completed the operation; thus, our study does not affect patients' choice of surgical method.

Eligibility criteria: Inclusion Criteria:

1） Patients who undergo the pelvic reconstruction surgery with trans-vaginal mesh; 2) Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation; 3）Willing to participate in 36 months of longitudinal follow-up and able to provide written informed consent. Willing to provide an email address and complete questionnaires on we-chat, either in clinic or elsewhere when they have access to the internet.

Exclusion Criteria:

* 1) Currently pregnant at enrollment;
* 2) Physically or mentally unable to participate in up to 36 months of follow-up;
* 3) Desires other surgical management of POP other than trans-vaginal mesh.

Primary outcomes:
measure: The incidence rate of complications
timeFrame: 12 months postoperatively
measure: The incidence rate of complications
timeFrame: 36 months postoperatively
Secondary outcomes:
measure: Anatomical cure rate in treated compartment of pelvic reconstructive surgery with trans-vaginal mesh
timeFrame: 6 weeks, 3 months and each year, up to 3-year postoperatively
measure: Change from preoperative scores of POP-Q(Pelvic organ prolapse quantitation) at each follow-up
timeFrame: Preoperatively; At 6weeks, 3 months, 1 year and assessed up to 3 year postoperatively
measure: Patient global impression of improvement (PGI-I)
timeFrame: At 6weeks, 3 months, 1 year and assessed up to 3 year postoperatively
measure: Changes in Pelvic Floor Distress Inventory-20 (PFDI-20) scores
timeFrame: Preoperatively; At 1 year and 3 year postoperatively
measure: Changes in Pelvic Floor Impact Questionnaire-7（PFIQ-7）scores
timeFrame: Preoperatively; At 1 year and 3 year postoperatively
measure: Changes in sexual function and measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire（PISQ-12）scores
timeFrame: Preoperatively; At 1 year and 3 year postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
name: Lan Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References: