Sacrospinous Ligament Fixation vs Ischial Spine Fascia Fixation
NCT ID: NCT03005613
Last Updated: 2019-12-30
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
NA
76 participants
INTERVENTIONAL
2017-01-31
2020-12-31
Brief Summary
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Detailed Description
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Study title：A Prospective, Randomized Comparison of Efficacy and Effect on Quality of Life Between Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation.
Principal Investigator：Chang Ren, M.D., Department of Obstetrics \& Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences \& Peking Union Medical College.
Study subjects：Adult patients with symptomatic stage II\~IV pelvic organ prolapse will be eligible if all the inclusion criteria are met and without any reason for exclusion.
Study objectives：The primary objective of this study is to assess the short and mid-term efficacy of Sacrospinous Ligament Fixation and Ischial Spine Fascia Fixation in treating stage II\~ IV pelvic organ prolapse and their recurrence rate as well as their impacts on quality of life.
Study design：Prospective, Single-Blind, Randomized, Clinical Trial
Intervention：
* ISFF group：Patients receive ISFF according to randomization.
* SSLF group：Patients receive SSLF according to randomization
Sample size：76 patients (38 in ISFF group, 38 in SSLF group)
Primary endpoint:
•objective success rates at 3 months after operations.
Secondary endpoints:
* peri-operative parameters .
* subjective satisfactory rates at 1 year after operations
* quality of life questionnaires at 1 year after operations
Safety endpoints: complications
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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sacrospinous ligament fixation group
The patients will receive sacrospinous ligament fixation operation.
sacrospinous ligament fixation
The participants will receive sacrospinous ligament fixation.
ischial spine fascia fixation group
The patients will receive ischial spine fascia fixation operation.
ischial spine fascia fixation
The participants will receive ischial spine fascia fixation.
Interventions
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ischial spine fascia fixation
The participants will receive ischial spine fascia fixation.
sacrospinous ligament fixation
The participants will receive sacrospinous ligament fixation.
Eligibility Criteria
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Inclusion Criteria
* patients with symptomatic stage II\~IV uterine or vaginal vault prolapse
* receiving SSLF or ISFF in the gynecological department at Peking Union Medical College Hospital
Exclusion Criteria
* contradiction to these two operations: acute genital infection, narrow vagina (less than two finger-breadth), too-ill to receive operations
* patients with hip joint problem who could not pose a lithotomy position
25 Years
65 Years
FEMALE
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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Chang Ren, M.D.
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Department of Ob & Gyn, Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Chang Ren, M.D.
Role: primary
References
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Dwyer PL, Lee ET, Hay DM. Obesity and urinary incontinence in women. Br J Obstet Gynaecol. 1988 Jan;95(1):91-6. doi: 10.1111/j.1471-0528.1988.tb06486.x.
Sze EH, Karram MM. Transvaginal repair of vault prolapse: a review. Obstet Gynecol. 1997 Mar;89(3):466-75. doi: 10.1016/S0029-7844(96)00337-7.
Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6.
Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010 Nov;116(5):1096-100. doi: 10.1097/AOG.0b013e3181f73729.
Boyles SH, Weber AM, Meyn L. Procedures for pelvic organ prolapse in the United States, 1979-1997. Am J Obstet Gynecol. 2003 Jan;188(1):108-15. doi: 10.1067/mob.2003.101.
Barber MD, Maher C. Apical prolapse. Int Urogynecol J. 2013 Nov;24(11):1815-33. doi: 10.1007/s00192-013-2172-1.
Jones KA, Shepherd JP, Oliphant SS, Wang L, Bunker CH, Lowder JL. Trends in inpatient prolapse procedures in the United States, 1979-2006. Am J Obstet Gynecol. 2010 May;202(5):501.e1-7. doi: 10.1016/j.ajog.2010.01.017. Epub 2010 Mar 11.
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.
Other Identifiers
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RC-H0407-8160061244
Identifier Type: -
Identifier Source: org_study_id