The Follow-up of Mesh/Native Tissue Complications Study(Part I)
NCT ID: NCT03620565
Last Updated: 2018-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
13120 participants
OBSERVATIONAL
2018-06-01
2023-12-31
Brief Summary
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Detailed Description
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Our follow-up process start after patients have completed the operation,thus our study do not affect patients' choice of surgical method.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Reconstruction with transvaginal mesh(TVM)
Patients who undertake pelvic reconstruction with tran-vaginal mesh(commercial mesh kits or self-cut synthesized mesh).
No interventions assigned to this group
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.
No interventions assigned to this group
Tension-free vaginal tape surgery(TVT)
Patients who undertake anti-incontinence surgeries(tension-free vaginal tape procedure).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
18 Years
80 Years
FEMALE
No
Sponsors
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Peking University People's Hospital
OTHER
Qilu Hospital of Shandong University
OTHER
Obstetrics & Gynecology Hospital of Fudan University，Shanghai Red House Obstetrics & Gynecology Hospital
UNKNOWN
Peking University Third Hospital
OTHER
First Hospitals affiliated to the China PLA General Hospital
OTHER_GOV
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
OTHER
Tongji Hospital
OTHER
The First Affiliated Hospital of Guangzhou Medical University
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Wuxi Obsetrics & Gynecology Hospital
UNKNOWN
Fuzhou General Hospital
OTHER
The First Affiliated Hospital of Jinan Hospital
UNKNOWN
Women's Hospital School Of Medicine Zhejiang University
OTHER
Renmin Hospital of Wuhan University
OTHER
The Third Hospital Affiliated Zhengzhou University
UNKNOWN
Shengjing Hospital
OTHER
General Hospital of Ningxia Medical University
OTHER
The Second Hospital of Hebei Medical University
OTHER
Gansu Provincial Maternal and Child Health Care Hospital
OTHER
First Affiliated Hospital of Xinjiang Medical University
OTHER
Yantai Yuhuangding Hospital，Medical College, Qingdao University
UNKNOWN
Southwest Hospital, China
OTHER
West China Second University Hospital
OTHER
Jiangxi Maternal and Child Health Hospital
OTHER
Shanxi Coal Central Hospital
UNKNOWN
Chongqing Medical University
OTHER
Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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Lan Zhu, MD
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Locations
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Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Beijing, Beiing, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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JS-1566-1
Identifier Type: -
Identifier Source: org_study_id
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