Clinical trial NCT03620565: The Follow-up of Mesh/Native Tissue Complications Study(Part I)
Official title: A Multi-center Study: The Follow-up of Complications for Women Having Pelvic Reconstruction Surgery With Mesh/Native Tissue(Part I)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Floor
Keywords: Pelvic floor reconstructive surgery
Mesh
Native tissue
Tape
Complication
the 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: Shanxi Coal Central Hospital
name: Chongqing Medical University
First posted: 2018-08-08
Enrollment: 13120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The frequency and incidence rate of different complications
timeFrame: at 6-week postoperatively
measure: The frequency and incidence rate of different complications
timeFrame: at 3-month postoperatively
measure: The frequency and incidence rate of different complications
timeFrame: at 1-year postoperatively
measure: The frequency and incidence rate of different complications
timeFrame: at 2-year postoperatively
measure: The frequency and incidence rate of different complications
timeFrame: up to 3-year postoperatively
Secondary outcomes:
measure: Anatomical cure rates in treated compartment of different pelvic reconstructive surgeries
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.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
state: Beiing
Study officials:
affiliation: Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
name: Lan Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.