The Follow-up of Mesh/Native Tissue Complications Study(Part I)

NCT03620565 | Unknown

• 1 other identifier: JS-1566-1
• Study Type: observational
• Target: 13,120
• Locations: 1 country
• Sites: 1

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).

Conditions

Pelvic Floor

Keywords

Pelvic floor reconstructive surgery; Mesh; Native tissue; Tape; Complication; the CTS coding

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (2)

• Anatomical cure rates in treated compartment of different pelvic reconstructive surgeries

  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.

Study Arms (4)

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).

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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:
• 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).
• 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.
• 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.
• 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.
• \. The failure or recurrence of prolapse the same compartment that has been underwent repair using native tissue.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Peking University People's Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• Obstetrics & Gynecology Hospital of Fudan University，Shanghai Red House Obstetrics & Gynecology Hospital: collaborator
• Peking University Third Hospital: collaborator
• First Hospitals affiliated to the China PLA General Hospital: collaborator
• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: collaborator
• Tongji Hospital: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Wuxi Obsetrics & Gynecology Hospital: collaborator
• Fuzhou General Hospital: collaborator
• The First Affiliated Hospital of Jinan Hospital: collaborator
• Women's Hospital School Of Medicine Zhejiang University: collaborator
• Renmin Hospital of Wuhan University: collaborator
• The Third Hospital Affiliated Zhengzhou University: collaborator
• Shengjing Hospital: collaborator
• General Hospital of Ningxia Medical University: collaborator
• The Second Hospital of Hebei Medical University: collaborator
• Gansu Provincial Maternal and Child Health Care Hospital: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• Yantai Yuhuangding Hospital，Medical College, Qingdao University: collaborator
• Southwest Hospital, China: collaborator
• West China Second University Hospital: collaborator
• Jiangxi Maternal and Child Health Hospital: collaborator
• Shanxi Coal Central Hospital: collaborator
• Chongqing Medical University: collaborator

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

Beijing, Beiing, 100730, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 33443938 DERIVED

Study Officials

• Lan Zhu, MD

  Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuo Liang, MD

CONTACT

+8613718879529; leahleung@foxmail.com

Lan Zhu, MD

CONTACT

zhu_julie@vip.sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: August 8, 2018
• Study Start: June 1, 2018
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 8, 2018

Record last verified: 2018-06

Locations

CN (1)