Ignite Creation Date:
2024-07-17 @ 10:53 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482697
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-25
Brief Title:
Safety and Efficacy of Different Procedures of Colpocleisis a Randomized Controlled Trial
Sponsor:
Lan Zhu
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
To Compare the Clinical Efficacy and Complications of Total Colpocleisis and Partial Colpocleisis in the Treatment of Pelvic Organ Orolapse
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 POP is one of the most common benign gynecological diseases among middle-aged and elderly women which severely affects the quality of life of patients Colpocleisis for the treatment of POP has a high success rate and low incidence of complications The classic colpocleisis is divided into total colpocleisis and partial colpocleisis LeFort However there are no long-term follow-up large-scale randomized trials to compare the clinical efficacy complications between the two surgical methods This study aims to compare the incidence of surgical complications objective surgical success rate subjective satisfaction rate pelvic floor symptom improvement rate and regret rate in patients with pelvic organ prolapse treated by total colpocleisis and LeFort
Methods This trial is a prospective multicenter randomized non-blinded non-inferiority trial comparing the application of hysterectomy with total colpocleisis and LeFort in symptomatic pelvic organ prolapse patients with no need for vaginal sexual life and aged 70 years The primary outcome measure is the incidence of surgical complications including perioperative and postoperative complications within 3 months as well as the incidence of severe complications Secondary outcomes include the objective surgical success rate subjective satisfaction rate pelvic floor symptom improvement rate and regret rate at 3 months 1 year and 2 years post-surgery This study is a non-inferiority study based on the literature reports that the incidence of complications for colpocleisis and LeFort with hysterectomy are 114 and 70 respectively with a non-inferiority boundary value of 5 α0025 one-sided β02 and a ratio of 11 between the two groups The sample size is calculated to be n296 considering a 10 dropout rate a total of 330 patients need to be included
Discussion This is a randomized multicenter clinical trial that will provide evidence to demonstrate the differences in complications and efficacy between colpocleisis and LeFort with hysterectomy
Methods This trial is a prospective multicenter randomized non-blinded non-inferiority trial comparing the application of hysterectomy with total colpocleisis and LeFort in symptomatic pelvic organ prolapse patients with no need for vaginal sexual life and aged 70 years The primary outcome measure is the incidence of surgical complications including perioperative and postoperative complications within 3 months as well as the incidence of severe complications Secondary outcomes include the objective surgical success rate subjective satisfaction rate pelvic floor symptom improvement rate and regret rate at 3 months 1 year and 2 years post-surgery This study is a non-inferiority study based on the literature reports that the incidence of complications for colpocleisis and LeFort with hysterectomy are 114 and 70 respectively with a non-inferiority boundary value of 5 α0025 one-sided β02 and a ratio of 11 between the two groups The sample size is calculated to be n296 considering a 10 dropout rate a total of 330 patients need to be included
Discussion This is a randomized multicenter clinical trial that will provide evidence to demonstrate the differences in complications and efficacy between colpocleisis and LeFort with hysterectomy
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