Sacrospinous Ligament Fixation vs. Ischial Spine Fasicia Fixation With Conventional Surgical Instruments in Chinese Apical Prolapse Female Patients: a Multi-center, Prospective, Randomized Clinical Trial
Sponsor study identifier
interventional
320
1 country
5
Study Start
January 1, 2020
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Primary Completion
December 31, 2022
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Study Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This trial is designed to investigate the efficacy and safety of two native tissue repair procedure with conventional surgical instruments in Chinese apical prolapse female patients (POP-Q II-IV) and compare the outcome in prolapse women randomized to Sacrospinous ligament fixation (SSLF) and Ischial spinous fascia fixation (ISFF).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2025
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 25, 2019
Actual (reported)December 30, 2019
Actual (reported)January 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
rate of surgical success
definition for surgical success is symptomatic prolapse below grade II occurred at 3 months after operation, and the severest indication point in POP-Q evaluation was taken as the criterion. No vaginal swelling sensation, that is answer "no" for PFDI-20 Questionnaire Question 3, "Do you often see or feel vaginal tumors come out?". The patient's self-perception symptoms is improved or improved significantly, that is answer 1 or 2 for the PGI-C questionnaire. There is no need of further treatment for prolapse, such as reoperation or pessary.
up to 36 months after operation
rate of Postoperative recurrence
from 3 months after operation up to 36 months after operation
visual analogue scales
up to 36 months after operation, usuallly within 3 days after operation
changes between preoperative and postoperative symptomatic improvement using validated instruments(PFIQ-7)
up to 36 months after operation
changes between preoperative and postoperative symptomatic improvement using validated instruments(PFDI-20)
up to 36 months after operation
changes between preoperative and postoperative symptomatic improvement using validated instruments(PISQ-12)
up to 36 months after operation
native tissue repair procedure with conventional surgical instruments in Chinese apical prolapse female patients randomized to Sacrospinous ligament fixation (SSLF) .
native tissue repair procedure with conventional surgical instruments in Chinese apical prolapse female patients randomized to Ischial spinous fascia fixation (ISFF)
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
2nd Affiliated hospital of Anhui Medical college
Hefei, Anhui, 230041, China
1st Affiliated hospital of PLA general hospital
Beijing, Beijing Municipality, 100037, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
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.
Yongxian Lu
1st Affiliated hospital of PLA general hospital
Zhiyuan Dai
Shanghai First Maternity and Infant Hospital
Wenyan Wang
2nd Affiliated hospital of Anhui Medical college
Zhaoai Li
Shan'xi Province Women's and Children's Hospital
Lan Zhu, MD
CONTACT
First Submitted
December 25, 2019
First Posted
December 30, 2019
Study Start
January 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Concordance of Pelvic Organ Mobility Measurements Between the Finite Element Model and the Dynamic Pelvic Floor MRI in Patients Undergoing a Sacrospinofixation Surgery
Contact the study team to confirm eligibility.
Suzhou City Hospital
Suzhou, Jiangsu, 215008, China
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, 200040, China
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.
Yuling Wang
Foshan Women's and Children's Hospital
Shunyu Hou
Suzhou City Hospital
Xiangjuan Li
Hangzhou Women's and Children's Hospital
Lubin Liu
Chongqing Women's and Children's Hospital
Le Ma
Beijing Obstetrics and Gynecology Hospital
Tao Xu
Statistics Department of Peking Union Medical College
Joseph Schaffer
University of Texas Southwestern Medical Center
Marko J Jachtorowycz
Saint Francis Hospital
Lan Zhu
Peking Union Medical College Hospital
Yuxin Dai
Peking Union Medical College Hospital
December 31, 2022
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Study Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 2, 2020
Record last verified: 2019-12
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