RCT for SSLF vs. ISFF With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients
NCT ID: NCT04213027
Last Updated: 2020-01-02
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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RECRUITING
NA
320 participants
INTERVENTIONAL
2020-01-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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SSLF-CSI
native tissue repair procedure with conventional surgical instruments in Chinese apical prolapse female patients randomized to Sacrospinous ligament fixation (SSLF) .
native tissue repair procedures with conventional surgical instruments
Sacrospinous ligament fixation (SSLF): treatment for apical prolapse with vaginal fornix suspended to sacrospinous ligament; Ischial spinous fascia fixation (ISFF): treatment for apical prolapse with vaginal fornix suspended to ischial spinous fascia (ISFF).
ISFF-CSI
native tissue repair procedure with conventional surgical instruments in Chinese apical prolapse female patients randomized to Ischial spinous fascia fixation (ISFF)
native tissue repair procedures with conventional surgical instruments
Sacrospinous ligament fixation (SSLF): treatment for apical prolapse with vaginal fornix suspended to sacrospinous ligament; Ischial spinous fascia fixation (ISFF): treatment for apical prolapse with vaginal fornix suspended to ischial spinous fascia (ISFF).
Interventions
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native tissue repair procedures with conventional surgical instruments
Sacrospinous ligament fixation (SSLF): treatment for apical prolapse with vaginal fornix suspended to sacrospinous ligament; Ischial spinous fascia fixation (ISFF): treatment for apical prolapse with vaginal fornix suspended to ischial spinous fascia (ISFF).
Eligibility Criteria
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Inclusion Criteria
2. SSLF or ISFF is proceeded as described before，while ancillary procedures like vaginal hysterectomy, anterior/posterior vaginal wall repair without mesh or mid-urethral suspension could be performed simultaneously.
3. Women who have been eligible for long-term follow-up.
4. Women who agreed to participate in the study and signed informed consent.
Exclusion Criteria
2. Women who have contraindication for surgical procedure
3. Women who are unable to comply with the study procedures
FEMALE
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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zhulan
Professor
Principal Investigators
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Yongxian Lu
Role: PRINCIPAL_INVESTIGATOR
1st Affiliated hospital of PLA general hospital
Zhiyuan Dai
Role: PRINCIPAL_INVESTIGATOR
Shanghai First Maternity and Infant Hospital
Wenyan Wang
Role: PRINCIPAL_INVESTIGATOR
2nd Affiliated hospital of Anhui Medical college
Zhaoai Li
Role: PRINCIPAL_INVESTIGATOR
Shan'xi Province Women's and Children's Hospital
Yuling Wang
Role: PRINCIPAL_INVESTIGATOR
Foshan Women's and Children's Hospital
Shunyu Hou
Role: PRINCIPAL_INVESTIGATOR
Suzhou City Hospital
Xiangjuan Li
Role: PRINCIPAL_INVESTIGATOR
Hangzhou Women's and Children's Hospital
Lubin Liu
Role: PRINCIPAL_INVESTIGATOR
Chongqing Women's and Children's Hospital
Le Ma
Role: PRINCIPAL_INVESTIGATOR
Beijing Obstetrics and Gynecology Hospital
Tao Xu
Role: PRINCIPAL_INVESTIGATOR
Statistics Department of Peking Union Medical College
Joseph Schaffer
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center
Marko J Jachtorowycz
Role: PRINCIPAL_INVESTIGATOR
Saint Francis Hospital
Lan Zhu
Role: STUDY_CHAIR
Peking Union Medical College Hospital
Yuxin Dai
Role: STUDY_DIRECTOR
Peking Union Medical College Hospital
Locations
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2nd Affiliated hospital of Anhui Medical college
Hefei, Anhui, China
1st Affiliated hospital of PLA general hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Suzhou City Hospital
Suzhou, Jiangsu, China
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Lan Zhu, MD
Role: CONTACT
Facility Contacts
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Wenyan Wang
Role: primary
Yongxian Lu
Role: primary
Lan Zhu
Role: backup
Shunyu Hou
Role: primary
Zhiyuan Dai
Role: primary
References
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Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD004014. doi: 10.1002/14651858.CD004014.pub5.
Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013 Nov;24(11):1815-33. doi: 10.1007/s00192-013-2172-1.
Zhu L, Lang J, Zhang Q. Clinical study of ischia spinous fascia fixation--a new pelvic reconstructive surgery. Int Urogynecol J. 2011 Apr;22(4):499-503. doi: 10.1007/s00192-010-1307-x.
Ren C, Song XC, Zhu L, Ai FF, Shi HH, Sun ZJ, Chen J, Lang JH. [Prospective cohort study on the outcomes of sacrospinous ligament fixation using conventional instruments in treating stage Ⅲ-Ⅳ pelvic organ prolapse]. Zhonghua Fu Chan Ke Za Zhi. 2017 Jun 25;52(6):369-373. doi: 10.3760/cma.j.issn.0529-567X.2017.06.003. Chinese.
Haya N, Baessler K, Christmann-Schmid C, de Tayrac R, Dietz V, Guldberg R, Mascarenhas T, Nussler E, Ballard E, Ankardal M, Boudemaghe T, Wu JM, Maher CF. Prolapse and continence surgery in countries of the Organization for Economic Cooperation and Development in 2012. Am J Obstet Gynecol. 2015 Jun;212(6):755.e1-755.e27. doi: 10.1016/j.ajog.2015.02.017. Epub 2015 Feb 25.
Other Identifiers
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PekingUMCH SSLFvsISFF-CSI
Identifier Type: -
Identifier Source: org_study_id
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