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

Pelvic Floor Clinical Trial

Official title:

A Multi-center Study: The Follow-up of Complications for Women Having Pelvic Reconstruction Surgery With Mesh/Native Tissue(Part I)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03620565
• Other study ID #: JS-1566-1
• Status: Recruiting
• Start date: June 1, 2018
• Est. completion date: December 2023

Study information

• Verified date: June 2018
• Source: Peking Union Medical College Hospital
• Contact: Shuo Liang, MD
• Phone: +8613718879529
• Email: leahleung[@]foxmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13120
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Floor

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences	Beijing	Beiing

Sponsors (27)

Lead Sponsor

Collaborator

Peking Union Medical College Hospital

First Affiliated Hospital of PLA General Hospital (304), First Affiliated Hospital of Xinjiang Medical University, Fuzhou General Hospital, Gansu Provincial Maternity and Child-care Hospital, General Hospital of Ningxia Medical University, Jiangxi Maternal and Child Health Hospital, Obstetrics & Gynecology Hospital of Fudan University,Shanghai Red House Obstetrics & Gynecology Hospital, Peking University Third Hospital, People's Hospital of Peking University, Qilu Hospital of Shandong University, Renmin Hospital of Wuhan University, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital, Shanxi Coal Central Hospital, Shengjing Hospital, The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Jinan Hospital, The First Affiliated Hospital with Nanjing Medical University, The first Hospital Affiliated To Army Medical University, The Second Hospital of Hebei Medical University, The Third Affiliated Hospital of Chongqing Medical University, The Third Hospital Affiliated Zhengzhou University, Tongji Hospital of Tongji University, West China Second University Hospital, Women's Hospital School Of Medicine Zhejiang University, Wuxi Obsetrics & Gynecology Hospital, Yantai Yuhuangding Hospital,Medical College, Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Change from Preoperative scores of POP-Q(Pelvic organ prolapse quantitation) at each follow-up	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.