Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418451
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-13
Brief Title:
A Randomized Controlled Trial of Modified Ischial Spinous Fascia Fixation and Sacrospinous Ligament Fixation in the Treatment of Pelvic Organ Prolapse
Sponsor:
Lan Zhu
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
To Compare the Clinical Efficacy and Complications of Modified Ischial Spinous Fascia Fixation and Sacrospinous Ligament Fixation in the Treatment of Pelvic Organ Prolapse
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Pelvic organ prolapse is one of the most common benign gynecological disorders in middle-aged and elderly women and it has a significant negative impact on womens social physical and psychological health Sacrospinous ligament fixation SSLF is one of the main surgical procedures for reconstructing pelvic floor defects In previous studies the ischial spine fascia fixation ISFF technique developed by our team has been shown to be a safe and effective alternative to SSLF However both procedures have inadequate support for the anterior vaginal wall Therefore based on the traditional ISFF we fix the anterior vaginal wall to the ipsilateral ischial spine fascia to enhance support for the anterior vaginal wall This modified procedure is called modified ISFF This trial aims to compare the subjective and objective therapeutic effects recurrence rates quality of life perioperative parameters and complications of modified ISFF and SSLF in the treatment of patients with pelvic organ prolapse of degrees II-IV
Methods This trial is a randomized controlled multicenter non-inferiority trial The primary outcome measure is the composite surgical success rate at one-year follow-up defined as the absence of subjective vaginal bulge symptoms no need for retreatment and absence of POP-Q points at or beyond the hymen or vaginal introitus ie Aa Ba C Ap Bp all 0 cm The secondary outcomes include anatomical outcomes of each vaginal segment based on the POP-Q score subjective improvement in quality of life evaluated by questionnaires PFIQ-7 PFDI-20 PISQ-12 and PGI-I perioperative parameters operation time blood loss length of hospital stay pain VAS score hospital costs and complications Data analysis will be conducted according to the intention-to-treat principle Based on a composite success rate of 88 and a non-inferiority margin of -10 one-sided α 0025 β 02 370 patients will be recruited from 9 centers including a 10 dropout rate The purpose of this study is to investigate whether modified ISFF is non-inferior to SSLF in terms of clinical efficacy and complications
Discussion This multicenter non-inferiority trial will evaluate the effectiveness and safety of modified ISFF compared to SSLF in symptomatic patients with degrees II-IV uterovaginal prolapse If modified ISFF is proven to be non-inferior to SSLF it would be a preferable alternative for patients with a shorter vaginal length and those who have difficulties with SSLF due to anatomical factors
Methods This trial is a randomized controlled multicenter non-inferiority trial The primary outcome measure is the composite surgical success rate at one-year follow-up defined as the absence of subjective vaginal bulge symptoms no need for retreatment and absence of POP-Q points at or beyond the hymen or vaginal introitus ie Aa Ba C Ap Bp all 0 cm The secondary outcomes include anatomical outcomes of each vaginal segment based on the POP-Q score subjective improvement in quality of life evaluated by questionnaires PFIQ-7 PFDI-20 PISQ-12 and PGI-I perioperative parameters operation time blood loss length of hospital stay pain VAS score hospital costs and complications Data analysis will be conducted according to the intention-to-treat principle Based on a composite success rate of 88 and a non-inferiority margin of -10 one-sided α 0025 β 02 370 patients will be recruited from 9 centers including a 10 dropout rate The purpose of this study is to investigate whether modified ISFF is non-inferior to SSLF in terms of clinical efficacy and complications
Discussion This multicenter non-inferiority trial will evaluate the effectiveness and safety of modified ISFF compared to SSLF in symptomatic patients with degrees II-IV uterovaginal prolapse If modified ISFF is proven to be non-inferior to SSLF it would be a preferable alternative for patients with a shorter vaginal length and those who have difficulties with SSLF due to anatomical factors
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None